Rheumatoid Arthritis Clinical Trial
Official title:
An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent
Verified date | February 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to prior treatment with DMARDs and/or one anti-TNF alpha agent. Patients will be treated with MabThera (1000mg i.v.) on days 1 and 15; they may receive concomitant treatment with DMARDs, corticosteroids, NSAIDs and analgesics throughout the study period. After week 36, eligible patients may receive re-treatment with MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 200 individuals.
Status | Completed |
Enrollment | 215 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients, >=18 years of age; - rheumatoid arthritis; - inadequate response to previous or current treatment with DMARDs and/or 1 anti-TNF agent. Exclusion Criteria: - rheumatic autoimmune disease or inflammatory joint disease other than RA; - concurrent treatment with an anti-TNF alpha therapy; - active infection or significant uncontrolled disease or malignancy. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events, laboratory parameters | Throughout study | No | |
Secondary | Categorical DAS responders | Week 24 | No | |
Secondary | Change in bone density | Throughout study | No |
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