MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02468791
• Date of registration: 09/06/2015
• Prospective Registration: No
• Primary sponsor: Mabion SA
• Public title: MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
• Scientific title: A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis
• Date of first enrolment: May 2013
• Target sample size: 709
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02468791
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Bosnia and Herzegovina, Georgia, Poland, Serbia, Ukraine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with active rheumatoid arthritis with disease duration minimum 6 months prior
to screening visit

- Patients who are naive to tumor necrosis factor (TNF) antagonists or any other
monoclonal antibody therapies

- Patients who have had an inadequate response to an adequate regimen of methotrexate

Exclusion Criteria:

- History of current rheumatic autoimmune disease other than RA and current inflammatory
joint disease other than RA

- Contraindications according to the MabThera SmPC and every serious coexisting diseases
which, in the Investigator's opinion, would preclude subject participation

- Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody,
hepatitis C antibody

- Prior treatment with rituximab, other anti-CD20 mAb, anti-TNF-alpha drug or any other
monoclonal antibodies

- Pregnancy or lactation or women planning to get pregnant during the course of the
study and/or within 12 months post last study drug infusion

- Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components

- Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
or previous treatment of any lymphocyte-depleting therapies



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Percentage of patients in each treatment group achieving the primary efficacy endpoint of a = 20% improvement on the American College of Rheumatology score (ACR20) at Week 24. [Time Frame: 24 weeks]

Secondary ID(s)

MabionCD20-001RA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors