CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 140 enrolled
Drug / intervention
Experimental: Arm A: DRL_RI +1 morebiological
Likely dose
Experimental: Arm A: DRL_RI 100mgfrom 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.

Search/NCT04268771
NCT04268771Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy's Laboratories Limited·interventional·Posted Feb 13, 2020·Updated Nov 18, 2023

In Brief

A Phase 3 clinical trial evaluating Experimental: Arm A: DRL_RI and Arm B: Rituxan®/Mabthera® for Rheumatoid Arthritis. Completed, enrolled 140 participants across 26 sites.

Detailed Summary

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab. The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL\_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab To assess the safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
CollaboratorsPPD Development, LP

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedFeb 13, 2020
Enrollment StartApr 8, 2020
Primary CompletionJan 26, 2022
Study CompletionApr 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.4 years ago

Interventions

Experimental: Arm A: DRL_RIbiological

Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion

Arm B: Rituxan®/Mabthera®biological

Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion