MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Sponsor
Mabion SA
Study ID
NCT02468791
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2013
Status verified
May 2020
Primary completion
May 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
709 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MabionCD20®
    A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
  • Active Comparator: MabThera®
    A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.

Primary Outcome Measure

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 ]

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