Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

Completed

Conditions: Rheumatoid Arthritis

Registration Number: NCT00234884

Lead Sponsor: Abbott

Brief Summary: The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Detailed Description: This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3435

Inclusion Criteria

Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
Participants must have been willing to consent to data being collected and provided to Abbott.

Exclusion Criteria

· Participants with contraindications according to the SmPC.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.
American College of Rheumatology 20% (ACR20) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 50% (ACR50) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 70% (ACR70) Response Rate	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value	HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (311): Site Ref # / Investigator 5606
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Camperdown, New South Wales, Australia
Site Ref # / Investigator 49504
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New Lambton, New South Wales, Australia
Site Ref # / Investigator 49508
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Brisbane, Queensland, Australia
Site Ref # / Investigator 49505
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Woodville, South Australia, Australia
Site Ref # / Investigator 49503
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West Heidelberg, Victoria, Australia
Site Ref # / Investigator 49502
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Cairns, Australia
Site Ref # / Investigator 49747
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Bad Schallerbach, Austria
Site Ref # / Investigator 49517
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Graz, Austria
Site Ref # / Investigator 49521
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Graz, Austria
Site Ref # / Investigator 49518
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Innsbruck, Austria
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Site Ref # / Investigator 5606
🇦🇺Camperdown, New South Wales, Australia