Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit. Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups: - Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2) - Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2) - Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2) - Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2) Starting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD. ;
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