A phase 3B/4 randomized double blind placebo controlled study of methotrexate (MTX) withdrawal in subjects with rheumatoid arthritis (RA) treated with tofacitinib 11MG modified release (MR) formulation
Abstract
This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.
Conditions: Rheumatoid Arthritis.
Primary outcome: Double Blind Phase: Change From Randomization in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 48.
Enrollment: 694 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 694 participants or records.
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