CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 384 enrolled
Drug / intervention
CT-P10 +2 morebiological
Likely dose
CT-P10 1000mgfrom 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/NCT02149121
NCT02149121Phase 3Completed
CompareCT.gov

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis

Celltrion·interventional·Posted May 29, 2014·Updated Dec 16, 2021

In Brief

A Phase 3 clinical trial evaluating CT-P10, Rituxan, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 384 participants.

Detailed Summary

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.1 years ago

Interventions

CT-P10biological

1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

Rituxandrug

US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

MabTheradrug

EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion