Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Biogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alp...
Eligibility Criteria
Inclusion
- Adult participants 18-80 years of age with active RA for at least 6 months;
- Received treatment for RA on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy (etanercept, infliximab or adalimumab);
- Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose;
- Participants with swollen joint count (SJC) and tender joint count (TJC) of at least 8 joints at screening and at randomization;
- Radiographic evidence of at least 1 joint with a definite erosion due to RA;
- Participants of reproductive potential must be using reliable contraceptive methods.
Exclusion
- Bone or joint surgery within 8 weeks prior to screening or joint surgery planned within 24 weeks of randomization;
- Class IV functional status of RA;
- Previous treatment within 6 months with intravenous gamma globulin, or the Prosorba column;
- Intraarticular or parenteral corticosteroids within 4 weeks prior to screening visit;
- With a live vaccine within 4 weeks prior to randomization;
- Previous treatment with rituximab or other cell-depleting therapies;
- Concurrent treatment with any disease-modifying anti-rheumatic drug (except for MTX) or any anti-TNF alfa factor or other biologic therapy;
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders;
- Known contraindications to receiving rituximab;
- Known active bacterial, viral, fungal, mycobacterial or other infection;
- History of recurrent significant infection or history of recurrent bacterial infections;
- Primary or secondary immunodeficiency (history of, or currently active);
- History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured);
- Women who are pregnant or breast-feeding;
- History of alcohol, drug or chemical abuse within 6 months prior to screening;
- Neuropathies and neurovasculopathies which might interfere with pain evaluation;
- Participants with poor peripheral venous access;
- Intolerance or contraindications to oral or intravenous corticosteroids.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00468546
Start Date
May 1 2003
End Date
July 1 2012
Last Update
October 25 2016
Active Locations (115)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35294
2
Mesa, Arizona, United States, 85208
3
Paradise Valley, Arizona, United States, 85253
4
Tucson, Arizona, United States, 85724