A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- patients of reproductive potential must be using reliable contraceptive methods.
- adult patients 18-80 years of age with active RA;
- eligible for re-treatment, based on clinical symptoms;
- ...
- patients of reproductive potential must be using reliable contraceptive methods.
- adult patients 18-80 years of age with active RA;
- eligible for re-treatment, based on clinical symptoms;
- patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
Exclusion Criteria
- current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- women who are pregnant or breast-feeding.
- patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- ...
- current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- women who are pregnant or breast-feeding.
- patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- development of any new contraindications to receiving MabThera;
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Inclusion Criteria
- patients of reproductive potential must be using reliable contraceptive methods.
- adult patients 18-80 years of age with active RA;
- eligible for re-treatment, based on clinical symptoms;
- ...
- patients of reproductive potential must be using reliable contraceptive methods.
- adult patients 18-80 years of age with active RA;
- eligible for re-treatment, based on clinical symptoms;
- patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
Exclusion Criteria
- current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- women who are pregnant or breast-feeding.
- patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- ...
- current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- women who are pregnant or breast-feeding.
- patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- development of any new contraindications to receiving MabThera;
Tracking Information
- NCT #
- NCT02097745
- Collaborators
- Biogen
- Investigators
- Study Chair: Clinical Trials Hoffmann-La Roche
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