ORBIT study
Phase 1
Recruiting
- Conditions
- Rheumatoid Arthritis
- Registration Number
- PACTR201208000399382
- Lead Sponsor
- Dr B Hodkinson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1)meet the 2011 revised American College of Rheumatology/EULAR classification criteria for RA
2)>18 years of age
3)naive to DMARD therapy at baseline
4)informed consent
Exclusion Criteria
Patients with contra-indication to methotrexate or corticosteroid therapy will be excluded (eg patients with Hepatitis B or C, HIV positive, pregnant or lactating or planning pregnancy within the next 12 months, uncontrolled diabetes mellitus)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the clinical utility of the CDAI versus the SDAI in an intense outpatient management strategy in patients with early rheumatoid arthritis
- Secondary Outcome Measures
Name Time Method To assess the outcomes of the two groups in terms of functional disability and health-related quality of life