At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 203 enrolled
Drug / intervention
Infliximabbiological
Likely dose
Infliximab 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 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).
In Brief
A Phase 4 clinical trial evaluating Infliximab for Rheumatoid Arthritis. Completed, enrolled 203 participants across 76 sites in 10 countries.
Detailed Summary
The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustria, Canada, Finland, France, Germany, Israel, Netherlands, Spain, United Kingdom, United States
CollaboratorsSchering-Plough
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionJan 2010
Study CompletionJun 2010
TodayJul 2026
First PostedJul 14, 2008
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.0 years ago
Interventions
Infliximabbiological
3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response