MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Patients with active moderate-to-severe rheumatoid arthritis diagnosed according to the 2010 ACR criteria will be randomized to receive treatment with stable methotrexate therapy with either MabionCD20, MabThera or Rituxan. Patients will be followed for a minimum of 24 weeks to establish pharmacokin...
Patients with active moderate-to-severe rheumatoid arthritis diagnosed according to the 2010 ACR criteria will be randomized to receive treatment with stable methotrexate therapy with either MabionCD20, MabThera or Rituxan. Patients will be followed for a minimum of 24 weeks to establish pharmacokinetic and clinical similarity and to compare PD, safety and immunogenicity parameters between the three rituximab products.
Tracking Information
- NCT #
- NCT04680962
- Collaborators
- Not Provided
- Investigators
- Not Provided
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