A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
- Conditions
- Rheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-005634-19-HU
- Lead Sponsor
- MedImmune Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 280
• A diagnosis of adult onset RA in line with the protocol
• Moderately active disease in line with the protocol
• A pre-defined number of swollen joints in line with the protocol
• Inadequate response to one or more conventional DMARDs
• No evidence of respiratory disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 252
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49
• A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement
secondary to RA
• A history of, or current, inflammatory joint disease other than RA
• Previous treatment with the investigational drug
• Discontinuation of a biologic DMARD due to lack of efficacy.
• Non-compliant concurrent medications
• Non-compliance with medical history criteria
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