A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA
Phase 1
- Conditions
- Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RAMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2007-004694-26-BE
- Lead Sponsor
- Saint-Luc Universitary Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Diagnosis of UA
Absence of ACR criteria
Active UA defined by a swollen joint count = 1 and < 4
Positive anti-CCP
Disease duration < 2 years
DMARDs naive
No chronic treatment with steroïds (> 3 months), if needed washout of 4 weeks
NSAIDs stable
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Other rheumatic inflammatory diagnosis.
Contraindication to MRI (pace-maker, etc.)
Congestive heart disease
Active or latent tuberculosis
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