Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period |
The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method. |
From randomization to first flare or last ISGA assessment (up to 52 weeks) |
|
| Primary |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention). |
Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks) |
|
| Secondary |
Number of Flare-Free Days During the DB Period |
Flare - free days was the sum of the duration of flare-free maintenance during the DB maintenance period for each participant. |
Up to maximum of 52 weeks |
|
| Secondary |
Number of Flares During the DB Period |
Flare was defined as an ISGA score of >=2. The ISGA is a 5-point scale (range 0 to 4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). |
Up to maximum of 52 weeks |
|
| Secondary |
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS |
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA>=2) during 52-week DB period evaluated among pruritus responders at randomization. Responders=participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline obtained at randomization. If event (e.g., death, first flare[ISGA >=2], lost to follow up or end of study) occurred before loss of pruritus response for first flare-free period, duration of pruritus response maintenance was time from randomization to last assessment and was censored. Here,pruritus response maintenance duration was presented for participants aged >=12 years with OL baseline PP NRS >=3, >=4 and >=3, >=4 points reduction from OL baseline to randomization in PP NRS. PP NRS: Participants were asked to rate their itch at worst moment during previous 24 hours on a scale of 0 to 10; 0=no itch and 10=worst itch imaginable". |
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks) |
|
| Secondary |
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS |
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset (ISGA>=2) during 52-week DB period. Evaluated among pruritus responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline that was obtained at randomization. If an event (e.g., death, first flare [ISGA >=2], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 6 to <12 years with baseline PRIS >=2 and >=2 points reduction from baseline to randomization in PRIS. PRIS: a 5-point scale (range: 0=no itch to 4=worst itch imaginable) and was completed by participants. |
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks) |
|
| Secondary |
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months |
Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA>=2)during52-weekDB period. Evaluated among pruritus responders (success in ISGA, EASI 50) at randomization. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline obtained at randomization. If event(e.g., death, first flare[ISGA >=2], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 3 to <6 months with OL baseline ORIS>=3 or >=4 and >=3 or >=4 points reduction from OL baseline to randomization in ORIS. Caregivers were asked to rate observation of their child's itch(scratching, rubbing) at worst moment during previous 24 hours on a scale of 0 to 10;0=no itch,10=worst itch imaginable. |
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks) |
|
| Secondary |
Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. EASI response maintenance = score that does not lose more than 50% of achieved reduction from Day1/Baseline run-in EASI score. |
From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks) |
|
| Secondary |
Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period |
Duration of DLQI maintenance=time from randomization to loss of DLQI response during 52-week DB period for responders at randomization. If event(e.g., death, first flare[ISGA >=2], lost to follow up or end of study) occurred before loss of DLQI response, duration of maintenance of DLQI response=time from randomization to last assessment and censored. Responders=participants with success in ISGA,EASI50 criteria. DLQI response maintenance=response that does not lose more than minimal clinical important difference. DLQI =10-item questionnaire, measured impact of skin disease in participants aged >=16 years. Children's DLQI (CDLQI): participants aged 4 to15 years. Each question in DLQI and CDLQI evaluated on 4-point scale (range 0=not at all to 3=very much). Scores from10 items were added for DLQI/CDLQI total score, range:0 (not at all) to 30 (very much). Higher scores=more impact on quality of life of participants/children. |
From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks) |
|
| Secondary |
Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period |
POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Duration of POEM maintenance was time from randomization to loss of POEM response during 52-week DB period for responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. If an event (e.g., death, first flare [ISGA >=2], lost to follow up, or end of study) occurred before loss of POEM response, duration of maintenance of POEM response was time from randomization to last assessment and was censored. Proxy POEM was used for participants aged 3 months to <12 years. |
From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks) |
|
| Secondary |
Investigator's Static Global Assessment (ISGA) Score for the First Flare Period |
ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. First flare period was the time from the onset of flare (ISGA>=2) during DB maintenance period where the participant was switched to receive open-label crisaborole ointment 2%, BID for up to 12 weeks until resolution of flares. |
Week 0 (Day 1), Week 4, Week 8 and Week 12 |
|
| Secondary |
EASI Score for the First Flare Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema[E], induration/papulation[I], excoriation[Ex], lichenification[L]) and % body surface area(BSA) affected.Each of clinical signs scored separately for each of 4 body regions (head and neck[h], upper limbs[u], trunk[t] [including axillae and groin], lower limbs[l] [including buttocks]) on 4-point scale: 0= absent; 1=mild; 2= moderate; 3= severe.EASI area score(A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.First flare period=time from onset of flare(ISGA>=2) during DB maintenance period where participant was switched to receive open-label crisaborole ointment 2%,BID for up to 12 weeks until resolution of flares. |
Week 0 (Day 1), Week 4, Week 8 and Week 12 |
|
| Secondary |
Duration (Days) of Flare Period |
Duration of flare period was average duration calculated from sum of durations divided by number of flares for each participant. |
Up to 52 weeks |
|
| Secondary |
Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to % BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. |
Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period |
EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. |
Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period |
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period |
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period |
ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period |
ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. The period for which OL crisaborole 2% ointment BID was initiated for treatment of flare developed during DB maintenance until resumption of DB treatment was defined as flare treatment period. |
Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12 |
|
| Secondary |
Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period |
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD. |
Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8 |
|
| Secondary |
Change From Baseline in Treatable %BSA: DB Period |
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Change From Baseline in Treatable %BSA: First Flare Free Period |
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Change From Baseline in Treatable %BSA: First Flare Period |
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD. |
Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12 |
|
| Secondary |
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period |
The investigators were required to draw the skin areas affected by AD for each participant in a body map and the most commonly affected BSA was documented. |
Baseline (last observation up to and including the randomization day), Weeks 24 and 52 |
|
| Secondary |
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period |
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Night Time Itch Score for Participants >=12 Years of Age: DB Period |
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period |
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period |
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency. |
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period |
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period |
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period |
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain. |
Weeks 0, 4, 8, 12 |
|
| Secondary |
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period |
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Patient/Observer Global Impression of Severity Score: OL Run-in Period |
Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Patient/Observer Global Impression of Severity Score: DB Period |
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Patient/Observer Global Impression of Severity Score: First Flare Period |
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Patient/Observer Global Impression of Severity Score: First Flare Free Period |
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Patient/Observer Global Impression of Change Score: OL Run-in Period |
Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age. |
Weeks 2, 4, 6 and 8 |
|
| Secondary |
Patient/Observer Global Impression of Change Score: DB Period |
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Patient/Observer Global Impression of Change Score: First Flare Period |
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Patient/Observer Global Impression of Change Score: First Flare Free Period |
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period |
The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period |
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure. |
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period |
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period |
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period |
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period |
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period |
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period |
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period |
EQ-5D Y VAS was used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period |
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health). |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period |
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQoL. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period |
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period |
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period |
EQ-5D-5L VAS to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state. |
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period |
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state. |
Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period |
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health). |
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period |
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period |
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period |
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period |
EQ-5D-5L VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period |
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period |
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health). |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period |
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period |
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status. |
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period |
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant. |
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period |
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state. |
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period |
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state. |
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period |
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health). |
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period |
WPAI plus CIQ was a 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1= currently employed; Q2= work hours missed due to health problems; Q3= work hours missed due to other reasons; Q4= hours actually worked; Q5= degree health affected productivity while working (0-10 scale, higher scores = less productivity); Q6= classes attended in academic setting or not; Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, higher scores = less productivity). Percent work time missed was calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher scores = greater impairment and less productivity. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were:Q1= currently employed;Q2= work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4= hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent impairment while working due to health problem was calculated as: 100*Q5/10 and score ranged from 0-100%,higher scores =greater impairment and less productivity. |
Weeks 0, 2, 4, 6 and 8 |
|
| Secondary |
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities (0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity. |
Weeks 0, 2, 4, 6 and 8 |
|
| Secondary |
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period |
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged: 0-100%, high numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%, higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5= degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged:0-100%, high numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%,higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
|
| Secondary |
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged:0-100%, high numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%, higher numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period |
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period |
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-anxiety (HADS-A) and HADS-depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. |
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8 |
|
| Secondary |
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period |
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. |
Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52] |
|
| Secondary |
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period |
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. |
Weeks 0, 4, 8 and 12 |
|
| Secondary |
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period |
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms. |
Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32 |
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