Rheumatoid Arthritis Clinical Trial
Official title:
A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
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.
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Observational Model: Cohort, Time Perspective: Prospective
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