Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20 (Mabion SA) Compared to MabThera (rituximab, Roche) in Patients with Rheumatoid Arthritis
Phase of Trial: Phase III
Latest Information Update: 27 May 2019
At a glance
- Drugs Rituximab (Primary)
- Indications Rheumatoid arthritis
- Focus Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors Mabion
- 26 May 2019 Status changed from recruiting to completed.
- 04 Jun 2018 According to a Mabion S.A. media release, the company has submitted Marketing Authorization Application for MabionCD20 to the European Medicines Agency (MEA). This application includes data from this trial.
- 06 Nov 2015 Planned primary completion date changed from 1 Mar 2016 to 1 Dec 2016, as reported by ClinicalTrials.gov.