Status:
COMPLETED
A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study
Lead Sponsor:
Université Catholique de Louvain
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema...
Detailed Description
The effects of Glucocorticoïds and Infliximab have never been compared in early RA using MRI as primary outcome measure. In the current study, we compare the effects of MTX alone or in combination wit...
Eligibility Criteria
Inclusion
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.
Exclusion
- Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00396747
Start Date
June 1 2003
End Date
September 1 2005
Last Update
October 19 2007
Active Locations (1)
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1
Université catholique de Louvain
Brussels, Belgium, 1200