At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 312 enrolled
Drug / intervention
GP2013 +2 morebiological
Likely dose
GP2013 1000 mgfrom 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, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
In Brief
A Phase 2 clinical trial evaluating GP2013, MabThera, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 312 participants across 57 sites in 14 countries.
Detailed Summary
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Austria, Belgium, Brazil, Estonia, France, Germany, Hungary, India, Italy, Romania, Spain, Turkey (Türkiye), United States
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionJan 2016
Study CompletionNov 2016
TodayJul 2026
First PostedJan 11, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.5 years ago
Interventions
GP2013biological
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
MabTherabiological
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Rituxanbiological
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)