At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 493 enrolled
Drug / intervention
Upadacitinib +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.
Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494)
In Brief
A Phase 2 clinical trial evaluating Upadacitinib and Pneumococcal 13-valent conjugate vaccine (PCV-13) for Rheumatoid Arthritis. Completed, enrolled 493 participants across 124 sites in 18 countries.
Detailed Summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionJul 2021
TodayJul 2026
First PostedJan 30, 2014
Enrollment StartJan 24, 2014
Primary CompletionJul 29, 2021
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 12.4 years ago
Interventions
Upadacitinibdrug
Tablet taken orally
Pneumococcal 13-valent conjugate vaccine (PCV-13)biological
Administered by intramuscular injection