At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 197 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
In Brief
A Phase 3 clinical trial evaluating Placebo and Upadacitinib for Rheumatoid Arthritis. Completed, enrolled 197 participants across 50 sites.
Detailed Summary
This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response. Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMar 2016
Primary CompletionAug 2017
Study CompletionJun 2022
TodayJul 2026
First PostedMar 28, 2016
Enrollment StartMar 22, 2016
Primary CompletionAug 3, 2017
Study CompletionJun 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 years ago
Interventions
Placebodrug
Tablet; Oral
Upadacitinibdrug
Tablet; Oral