A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study
Information source: Université Catholique de Louvain
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Infliximab, methylprednisolone, methotrexate (Drug); Methotrexate (Drug); Methotrexate + Methylprednisolone (Drug); Methotrexate + Infliximab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Université Catholique de Louvain Official(s) and/or principal investigator(s):
Patrick Durez, MD, Principal Investigator, Affiliation: Université Catholique de Louvain
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 and erosive changes in early rheumatoid arthritis (RA) patients.
Clinical Details
Official title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: MRI synovitis, bone edema and erosions score
Secondary outcome: Efficacy (DAS Score, ACR response)Side effects
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 with intravenous (IV) methylprednisolone (MP) pulse therapy or IFX on
MRI-detected synovitis, bone edema and erosive changes in early RA patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Université catholique de Louvain, Brussels 1200, Belgium
Additional Information
Starting date: June 2003
Ending date: September 2005
Last updated: October 18, 2007
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