MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Rituximab

• Registration Number: NCT02468791
• Lead Sponsor: Mabion SA

Brief Summary

The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.

Detailed Description

Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Primary Completion: 2017-05
• Study Completion: 2017-10
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 709

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MabThera®	Rituximab	A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
MabionCD20®	Rituximab	A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.

Primary Outcome Measures

Name	Time	Method
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.	24 weeks

Trial Locations

Locations (51)

Clinical Centre Banja Luka Location Paprikovac; 🇧🇦 Banja Luka, Bosnia and Herzegovina

University Clinical Hospital Mostar; 🇧🇦 Mostar, Bosnia and Herzegovina

Clinical Centre University of Sarajevo; 🇧🇦 Sarajevo, Bosnia and Herzegovina

General Hospital "Dr. Abdulah Nakas"; 🇧🇦 Sarajevo, Bosnia and Herzegovina

University Clinical Centre Tuzla; 🇧🇦 Tuzla, Bosnia and Herzegovina

Carabs Medline Ltd; 🇬🇪 Tbilisi, Georgia

Cardio-Reanimation Center Ltd; 🇬🇪 Tbilisi, Georgia

Diagnostic Service ltd; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

MediClub Georgia; 🇬🇪 Tbilisi, Georgia

Scroll for more (41 remaining)