An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.
- Conditions
- Rheumatoid arthritisMedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-005649-10-GB
- Lead Sponsor
- MedImmune Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 138
• A diagnosis of at least moderately-active adult onset RA.
• Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol.
• Receiving oral or injectable methotrexate, as defined by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• A rheumatic autoimmune disease or other inflammatory joint disease other than RA.
• Previous treatment with biologic therapies other than anti-TNF for RA.
• Treatment with other DMARDs or NSAIDs, as defined by the protocol.
• Medical history as defined by the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method