At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 650 enrolled
Drug / intervention
PF-06438179 +1 morebiological
Likely dose
PF-06438179 3 mg/kgfrom 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 Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
In Brief
A Phase 3 clinical trial evaluating PF-06438179 and Infliximab for Rheumatoid Arthritis. Completed, enrolled 650 participants across 184 sites in 28 countries.
Detailed Summary
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Czechia, Georgia, Germany, Guatemala, Hungary, Israel, Japan, Jordan, Lithuania, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Tunisia, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartAug 2014
Primary CompletionJun 2016
Study CompletionJun 2017
TodayJul 2026
First PostedAug 21, 2014
Enrollment StartAug 26, 2014
Primary CompletionJun 29, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.9 years ago
Interventions
PF-06438179biological
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Infliximabbiological
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.