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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Biogen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
