Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis.
Phase of Trial: Phase I
Latest Information Update: 14 Nov 2016
At a glance
- Drugs Rituximab (Primary)
- Indications Rheumatoid arthritis
- Focus Pharmacokinetics; Registrational
- Acronyms Triad RA
- Sponsors Celltrion
- 14 Nov 2016 According to a Celltrion media release, data of phase I 72-week extension study and an additional 1 year switching study were presented in ACR 2015 and EULAR 2016.
- 13 Sep 2016 Results assessing pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety published in the Annals of the Rheumatic Diseases.
- 07 May 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History