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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,435
commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
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.
Time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 20% (ACR20) Response Rate
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).
Time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 50% (ACR50) Response Rate
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).
Time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 70% (ACR70) Response Rate
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).
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Site Ref # / Investigator 5606
Camperdown, New South Wales, Australia
Site Ref # / Investigator 49504
New Lambton, New South Wales, Australia
Site Ref # / Investigator 49508
Brisbane, Queensland, Australia
Site Ref # / Investigator 49505
Woodville, South Australia, Australia
Site Ref # / Investigator 49503
West Heidelberg, Victoria, Australia
Site Ref # / Investigator 49502
Cairns, Australia
Site Ref # / Investigator 49747
Bad Schallerbach, Austria
Site Ref # / Investigator 49517
Graz, Austria
Site Ref # / Investigator 49521
Graz, Austria
Site Ref # / Investigator 49518
Innsbruck, Austria
...and 301 more locations
Time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
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).
Time frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value