A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)
Summary
The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.
Timeline
- Start
- 2018-01-03
- Primary completion
- 2019-08-14
- Completion
- 2020-09-03
Outcome
Met primary endpoint
registry NUMBER Placebo: 31.4 (24.4 to 38.4) percentage of participants NCT02955212 ↗
registry NUMBER Upadacitinib 15 mg: 71.6 (64.8 to 78.4) percentage of participants NCT02955212 ↗
registry analysis (superiority test); Placebo vs Upadacitinib 15 mg; p <0.001; Response Rate Difference 40.2 (95% CI 30.5 to 50.0); Cochran-Mantel-Haenszel NCT02955212 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Upadacitinib | Small molecule | 15 mg | Oral |