CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 276 enrolled
Drug / intervention
DRL_RI +2 morebiological
Likely dose
DRL_RI 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.

Search/NCT02296775
NCT02296775Phase 2Completed
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Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

Dr. Reddy's Laboratories Limited·interventional·Posted Nov 20, 2014·Updated Jan 13, 2020

In Brief

A Phase 2 clinical trial evaluating DRL_RI, Rituxan, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 276 participants across 28 sites in 2 countries.

Detailed Summary

This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL\_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesIndia, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 20, 2014
Enrollment StartNov 1, 2014
Primary CompletionNov 1, 2016
Study CompletionOct 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.6 years ago

Interventions

DRL_RIbiological

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15

Rituxanbiological

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15

MabTherabiological

Two 1000 mg intravenous infusions, one each on Day 1 and Day 15