Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Verified date | September 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will assess the safety and efficacy of rituximab combined with MTX in participants with active RA who have had an inadequate response to anti-TNF alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.
Status | Completed |
Enrollment | 522 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche | Biogen |
United States, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With American College of Rheumatology 20 (ACR20) Response at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With an ACR50 Response at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With ACR70 Response at Week 24 | Week 24 | No | |
Secondary | Change from Baseline in Disease Activity Score of 28 Joints (DAS28) at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission at Week 24 | Week 24 | No | |
Secondary | Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24 | Week 24 | No | |
Secondary | Change from Baseline in the ACR Core Set (SJC, TJC, Participant's and Physician's Global Assessments, Health Assessment Questionnaire [HAQ], Pain, C-Reactive Protein [CRP], and Erythrocye Sedimentation Rate [ESR]) Scores at Week 24 | Week 24 | No | |
Secondary | Change From Baseline of Short Form 36 (SF-36) Total Scores at Week 24 | Week 24 | No | |
Secondary | Change From Baseline in the Physical and Mental Component Scores of SF-36 at Week 24 | Week 24 | No | |
Secondary | Change From Baseline in the Genant-modified Sharp Total Score at Weeks 24, 56, and 104 | Weeks 24, 56 and 104 | No | |
Secondary | Change From Baseline in the Genant-modified Sharp Erosion Score at Weeks 24, 56, and 104 | Weeks 24, 56, and 104 | No | |
Secondary | Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Weeks 24, 56, and 104 | Weeks 24, 56, and 104 | No |
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