At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 107 enrolled
Drug / intervention
GP2013 - A Proposed biosimilar rituximab +1 morebiological
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, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
In Brief
A Phase 3 clinical trial evaluating GP2013 - A Proposed biosimilar rituximab and Originator rituximab - Rituxan ® or MabThera ® for Rheumatoid Arthritis. Completed, enrolled 107 participants across 65 sites in 4 countries.
Detailed Summary
The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesGermany, Hungary, Poland, United States
CollaboratorsHexal AG
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedAug 2015
Primary CompletionJul 2016
Study CompletionOct 2016
TodayJul 2026
First PostedAug 4, 2015
Enrollment StartJul 1, 2015
Primary CompletionJul 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.9 years ago
Interventions
GP2013 - A Proposed biosimilar rituximabbiological
Originator rituximab - Rituxan ® or MabThera ®biological