Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202565
• Other study ID #: P12-165
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: July 15, 2014
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlRomania: Ethics CommitteeHungary: Research Ethics Medical CommitteeUkraine: State Pharmacological Center - Ministry of HealthSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeEstonia: The State Agency of MedicineCzech Republic: State Institute for Drug ControlSlovak Republic: Ethics Committee
• Study type: Observational

Clinical Trial Summary

There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.

The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.

Description:

This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.

Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).

As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index [PASI]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients will be enrolled in this PMOS if they fulfill all of the below criteria:

1. Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines

2. Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet = 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score = 10)

3. Adult (=18 years of age)

4. Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines

5. Willing to provide informed consent if requested by the local law regulations

Exclusion Criteria:

Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:

1. Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)

2. Participate in another clinical/observational study

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Czech Republic	Site Reference ID/Investigator# 63776	Chotoviny
Czech Republic	Site Reference ID/Investigator# 58083	Jihlava
Czech Republic	Site Reference ID/Investigator# 56762	Klimkovice
Czech Republic	Site Reference ID/Investigator# 56763	Klimkovice
Czech Republic	Site Reference ID/Investigator# 30742	Kostelec nad Ohri
Czech Republic	Site Reference ID/Investigator# 54503	Prague 10
Czech Republic	Site Reference ID/Investigator# 56542	Prague 2
Czech Republic	Site Reference ID/Investigator# 58084	Prague 8
Estonia	Site Reference ID/Investigator# 57562	Tallinn
Estonia	Site Reference ID/Investigator# 57563	Tallinn
Estonia	Site Reference ID/Investigator# 57564	Tallinn
Estonia	Site Reference ID/Investigator# 57567	Tartu
Hungary	Site Reference ID/Investigator# 30743	Budapest
Hungary	Site Reference ID/Investigator# 42506	Debrecen
Hungary	Site Reference ID/Investigator# 42507	Debrecen
Hungary	Site Reference ID/Investigator# 42508	Debrecen
Hungary	Site Reference ID/Investigator# 42509	Debrecen
Hungary	Site Reference ID/Investigator# 42510	Debrecen
Hungary	Site Reference ID/Investigator# 42514	Kaposvar
Hungary	Site Reference ID/Investigator# 42515	Kecskemet
Hungary	Site Reference ID/Investigator# 42516	Miskolc
Hungary	Site Reference ID/Investigator# 42511	Pecs
Hungary	Site Reference ID/Investigator# 42512	Pecs
Hungary	Site Reference ID/Investigator# 42513	Pecs
Hungary	Site Reference ID/Investigator# 44854	Pecs
Hungary	Site Reference ID/Investigator# 42502	Szeged
Hungary	Site Reference ID/Investigator# 42517	Szombathely
Israel	Site Reference ID/Investigator# 30744	Afula
Israel	Site Reference ID/Investigator# 49888	Jerusalem
Israel	Site Reference ID/Investigator# 49886	Petach Tiqwa
Israel	Site Reference ID/Investigator# 49887	Ramat Gan
Israel	Site Reference ID/Investigator# 51783	Tel Aviv
Romania	Site Reference ID/Investigator# 46184	Alexandria
Romania	Site Reference ID/Investigator# 44563	Bucharest
Romania	Site Reference ID/Investigator# 44564	Bucharest
Romania	Site Reference ID/Investigator# 44566	Bucharest
Romania	Site Reference ID/Investigator# 44567	Bucharest
Romania	Site Reference ID/Investigator# 44569	Bucharest
Romania	Site Reference ID/Investigator# 44571	Bucharest
Romania	Site Reference ID/Investigator# 44572	Bucharest
Romania	Site Reference ID/Investigator# 44575	Bucharest
Romania	Site Reference ID/Investigator# 44576	Bucharest
Romania	Site Reference ID/Investigator# 44580	Bucharest
Romania	Site Reference ID/Investigator# 46185	Bucharest
Romania	Site Reference ID/Investigator# 30745	Cluj-Napoca
Romania	Site Reference ID/Investigator# 44561	Constanta
Romania	Site Reference ID/Investigator# 44562	Constanta
Romania	Site Reference ID/Investigator# 44557	Craiova
Romania	Site Reference ID/Investigator# 44558	Craiova
Romania	Site Reference ID/Investigator# 44559	Craiova
Romania	Site Reference ID/Investigator# 44560	Craiova
Romania	Site Reference ID/Investigator# 44547	Iasi
Romania	Site Reference ID/Investigator# 44548	Iasi
Romania	Site Reference ID/Investigator# 44549	Iasi
Romania	Site Reference ID/Investigator# 46183	Oradea
Romania	Site Reference ID/Investigator# 44555	Ploiesti
Romania	Site Reference ID/Investigator# 44554	Reghin
Romania	Site Reference ID/Investigator# 44550	Targu Mures
Slovakia	Site Reference ID/Investigator# 30746	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 42521	Bratislava
Slovakia	Site Reference ID/Investigator# 42519	Kosice
Slovakia	Site Reference ID/Investigator# 42522	Martin
Slovakia	Site Reference ID/Investigator# 42518	Presov
Slovenia	Site Reference ID/Investigator# 30747	Ljubljana
Slovenia	Site Reference ID/Investigator# 44544	Ljubljana
Slovenia	Site Reference ID/Investigator# 44542	Maribor
Slovenia	Site Reference ID/Investigator# 47702	Sezana
Ukraine	Site Reference ID/Investigator# 64524	Donetsk
Ukraine	Site Reference ID/Investigator# 66642	Donetsk
Ukraine	Site Reference ID/Investigator# 62304	Kharkiv
Ukraine	Site Reference ID/Investigator# 56699	Kiev
Ukraine	Site Reference ID/Investigator# 55443	Lviv
Ukraine	Site Reference ID/Investigator# 70493	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Czech Republic,  Estonia,  Hungary,  Israel,  Romania,  Slovakia,  Slovenia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12	NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: 0 = none; 1 = present in 1/4 nail quadrants; 2 = present in 2/4 nail quadrants; 3 = present in 3/4 nail quadrants; 4 = present in 4/4 nail quadrants.; The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).; Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.	Baseline and Month 12	No
Primary	Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12	The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.; Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.	Baseline and Month 12	No
Secondary	Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: 0 = none; 1 = present in 1/4 nail quadrants; 2 = present in 2/4 nail quadrants; 3 = present in 3/4 nail quadrants; 4 = present in 4/4 nail quadrants.; The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).; A negative change from Baseline indicates improvement.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis	Good clinical response on nails is defined as = 50% improvement from Baseline in total NAPSI score.; The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: 0 = none; 1 = present in 1/4 nail quadrants; 2 = present in 2/4 nail quadrants; 3 = present in 3/4 nail quadrants; 4 = present in 4/4 nail quadrants.; The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving Complete Clearing of Nails	Complete clearing of nails is defined as a total NAPSI score of zero.; The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: 0 = none; 1 = present in 1/4 nail quadrants; 2 = present in 2/4 nail quadrants; 3 = present in 3/4 nail quadrants; 4 = present in 4/4 nail quadrants.; The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).	Months 3, 6, 9, and 12	No
Secondary	Change From Baseline in Psoriasis Scalp Severity Index (PSSI)	The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving Good Clinical Response on Scalp	Good clinical response on scalp is defined as a = 50% improvement from Baseline in PSSI score.; The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving Complete Clearing of Scalp	Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.	Months 3, 6, 9, and 12	No
Secondary	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.	Baseline and Month 12	No
Secondary	Change From Baseline in PASI Score	The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving a PASI 90 Response	The percentage of participants with a = 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.; PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving a PASI 75 Response	The percentage of participants with a = 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.; PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percentage of Participants Achieving a PASI 50 Response	The percentage of participants with a = 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.; PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score	The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.	Baseline and Month 12	No
Secondary	Change From Baseline in DLQI Score	The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.	Baseline and Months 3, 6, 9, and 12	No
Secondary	Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis	Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.	Baseline and Month 12	No
Secondary	Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis	Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.	Baseline and Month 12	No
Secondary	Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis	Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.	Baseline and Month 12	No
Secondary	Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis	Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.	Baseline and Month 12	No
Secondary	Associations Between General Improvement in Psoriasis With Improvement in Quality of Life	Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.	Baseline and Month 12	No

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