Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study

Rheumatoid Arthritis Clinical Trial

— New Indices  

Official title:

Current Adoption Of Composite Indices In Evaluating Rheumatoid Arthritis Patients: An Observational Study ("NEW INDICES Study")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793403
• Other study ID #: 0881A1-102317
• Secondary ID: 0881A-102317 ; B
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: December 31, 2012
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.

Description:

All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines.

• Patients eligible to anti-TNF therapy

• Patients naïve to anti-TNFa drugs

• Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form

Exclusion Criteria:

• Patients with tumors

• Patients already included in clinical trials

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• As per routinary clinical care
As per routine clinical care

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6	Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).	Month 6	No
Primary	Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12	Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).	Month 12	No
Primary	Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6	OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).	Month 6	No
Primary	Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12	OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.	Month 12	No
Primary	Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6	GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.	Month 6	No
Primary	Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12	GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.	Month 12	No
Primary	Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6	Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.; Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.	Month 6	No
Primary	Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12	Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.; Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.	Month 12	No
Primary	Disease Activity Score Based on 28-joints Count (DAS28) at Month 6	DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.	Month 6	No
Primary	Disease Activity Score Based on 28-joints Count (DAS28) at Month 12	DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.	Month 12	No
Primary	Simplified Disease Activity Index (SDAI) at Month 6	The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.	Month 6	No
Primary	Simplified Disease Activity Index (SDAI) at Month 12	The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.	Month 12	No
Primary	Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6	RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.	Month 6	No
Primary	Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12	RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.	Month 12	No
Primary	Clinical Disease Activity Index (CDAI) at Month 6	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.	Month 6	No
Primary	Clinical Disease Activity Index (CDAI) at Month 12	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.	Month 12	No
Primary	Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6	PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.	Month 6	No
Primary	Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12	PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.	Month 12	No
Primary	Clinical Arthritis Activity (CLARA) Index at Month 6	CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.	Month 6	No
Primary	Clinical Arthritis Activity (CLARA) Index at Month 12	CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.	Month 12	No
Primary	Patient Global Assessment (PtGA) of Disease Activity at Month 6	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.	Month 6	No
Primary	Patient Global Assessment (PtGA) of Disease Activity at Month 12	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.	Month 12	No
Primary	Physician Global Assessment (PGA) of Disease Activity at Month 6	Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.	Month 6	No
Primary	Physician Global Assessment (PGA) of Disease Activity at Month 12	Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.	Month 12	No
Primary	Visual Analog Fatigue Scale (VAFS) at Month 6	Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.	Month 6	No
Primary	Visual Analog Fatigue Scale (VAFS) at Month 12	Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.	Month 12	No
Primary	C-reactive Protein (CRP) at Month 6	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Month 6	No
Primary	C-reactive Protein (CRP) at Month 12	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Month 12	No
Primary	Erythrocyte Sedimentation Rate (ESR) at Month 6	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.	Month 6	No
Primary	Erythrocyte Sedimentation Rate (ESR) at Month 12	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.	Month 12	No
Primary	Number of Participants With Rheumatoid Factor (RF) at Month 6	RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.	Month 6	No
Primary	Number of Participants With Rheumatoid Factor (RF) at Month 12	RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.	Month 12	No
Primary	Patient's General Health Assessment at Month 6	Participants answered: "How would you describe your general health today?" Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.	Month 6	No
Primary	Patient's General Health Assessment at Month 12	Participants answered: "How would you describe your general health today?" Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.	Month 12	No
Primary	Patient Assessment of Arthritis Pain at Month 6	Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.	Month 6	No
Primary	Patient Assessment of Arthritis Pain at Month 12	Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.	Month 12	No
Primary	Duration of Morning Stiffness at Month 6	Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Month 6	No
Primary	Duration of Morning Stiffness at Month 12	Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Month 12	No
Primary	Health Assessment Questionnaire (HAQ) at Month 6	HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Month 6	No
Primary	Health Assessment Questionnaire (HAQ) at Month 12	HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Month 12	No
Primary	Recent-Onset Arthritis Disability (ROAD) at Month 6	ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.	Month 6	No
Primary	Recent-Onset Arthritis Disability (ROAD) at Month 12	ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.	Month 12	No
Primary	Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6	SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.	Month 6	No
Primary	Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12	SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.	Month 12	No

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