A Double Blind, Randomized, Placebo Controlled,Multi-Center Trial of Anti-TNF¨¢Chimeric Monoclonal Antibody (Infliximab, Remicade®)in Combination with Methotrexate in Patients withVery Early Inflammatory Arthritis.
Recruiting
- Conditions
- Very early inflammatory arthritis.
- Registration Number
- NL-OMON28713
- Lead Sponsor
- Josef S. Smolen MDDepartment of RheumatologyMedical University of ViennaWaehringer Guertel 18-20A-1090 Vienna, Austria+43-1-40400-4300josef.smolen@wienkav.at
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Men and women, >= 18 and <= 75 years of age, capable of understanding and signing an informed consent;
2. The presence of arthritis:
Exclusion Criteria
1. Have arthritis with a distinct diagnosis, made after a routine diagnostic work-up
(examples are SLE, psoriatic arthritis, systemic sclerosis, gout, pseudogout, Lyme
arthritis, reactive arthritis, Parvo viral arthritis);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of presence of clinical remission between treatment with infliximab plus MTX versus MTX monotherapy and supportive treatment only at end of infliximab therapy, i.e. at at least 2 consecutive visits after month 3 during the first 54 weeks.
- Secondary Outcome Measures
Name Time Method