A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFa Chimeric Monoclonal Antibody (infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis (DINORA Study)
Phase 3
Completed
- Conditions
- Rheumatoid arthritis-rheumatic disease1000381610023213
- Registration Number
- NL-OMON31097
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1) Men and women, >= 18 and <= 75 years of age
2) The presence of arthritis:
a) Must be established in a rheumatology center,
b) Must be present in at least 2 joints of the 66 joint count
c) Without any previous episodes of inflammatory joint disease
3) Duration of symptoms :
a) Must be 2 weeks at least
b) Must be 16 weeks at most
Exclusion Criteria
*previous treatment with corticoseroids or DMARD's
*positive tuberculosis test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Comparison of presence of clinical remission between treatment with infliximab<br /><br>plus MTX versus MTX monotherapy and supportive treatment only at end of<br /><br>infliximab therapy, i.e. at at least 2 consecutive visits after month 3 during<br /><br>the first 54 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method