A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

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This Phase 3 multicenter study included two periods. Period 1 was a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and 15 mg once daily versus placebo for the treatment of signs and symptoms of...

This Phase 3 multicenter study included two periods. Period 1 was a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs. Period 2 is a blinded long-term (up to 5 years) extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and 15 mg daily in participants who had completed Period 1 that is currently ongoing. Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups: Group 1: Upadacitinib 30 mg QD in Period 1 ? Upadacitinib 30 mg QD in Period 2 Group 2: Upadacitinib 15 mg QD in Period 1 ? Upadacitinib 15 mg QD in Period 2 Group 3: Placebo in Period 1 ? Upadacitinib 30 mg QD in Period 2 Group 4: Placebo in Period 1 ? Upadacitinib 15 mg QD in Period 2 Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region.

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