Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20 (Mabion SA) Compared to MabThera (rituximab, Roche) in Patients with Rheumatoid Arthritis
Latest Information Update: 18 May 2020
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At a glance
- Drugs Rituximab (Primary) ; Folic acid; Methotrexate
- 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.