At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 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 Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone
In Brief
A Phase 2 clinical trial evaluating Placebo and Upadacitinib for Rheumatoid Arthritis. Completed, enrolled 300 participants across 63 sites in 16 countries.
Detailed Summary
The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionJul 2015
TodayJul 2026
First PostedFeb 19, 2014
Enrollment StartMar 26, 2014
Primary CompletionJul 2, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.4 years ago
Interventions
Placebodrug
Tablets for oral administration
Upadacitinibdrug
Tablets for oral administration