At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 661 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 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in 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 661 participants across 167 sites in 38 countries.
Detailed Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedFeb 2016
Primary CompletionApr 2017
Study CompletionMar 2022
TodayJul 2026
First PostedFeb 5, 2016
Enrollment StartDec 17, 2015
Primary CompletionApr 21, 2017
Study CompletionMar 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.4 years ago
Interventions
Placebodrug
Tablet; Oral
Upadacitinibdrug
Tablet; Oral