Rheumatoid Arthritis Clinical Trial
Official title:
Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
The objective of a multicenter prospective observational study is to compare effectiveness and safety of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderately to severely active rheumatoid arthritis patients who have had an inadequate response or intolerace to methotrexate.
This study is a multicenter prospective observational study to show non-inferiority of
clinical efficacy for small molecular inhibitors after 48 week of treatment to biologic
disease modifying anti-rheumatic drugs (bDMARDs) in patients having moderately to severely
active RA and who have been intolerant to conventional synthetic disease modifying
anti-rheumatic drugs (csDMARDs) including methotrexate.
Primary end point is a percentage of participants of achieving low disease activity according
to Disease Activity Score in 28 joints-Erythrocyte Sedientation Rate (DAS28-ESR) at weeks 24.
A total of 506 RA patients will be included, and allocated in ratio of 1:1 to bDMARD group
and small molecule inhibitor group. Group allocation is determined by shared-decision making,
so that the number of participants could be re-assessed according to recruitment status of
participatns.
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