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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00396747
Date of registration: 06/11/2006
Prospective Registration: No
Primary sponsor: Université Catholique de Louvain
Public title: A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study
Scientific 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
Date of first enrolment: June 2003
Target sample size: 45
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00396747
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Belgium
Contacts
Name:     Patrick Durez, MD
Address: 
Telephone:
Email:
Affiliation:  Universit√© Catholique de Louvain
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate
Drug: Methotrexate + Infliximab
Drug: Methotrexate + Methylprednisolone
Primary Outcome(s)
MRI synovitis, bone edema and erosions score [Time Frame: baseline, week 18 and 52]
Secondary Outcome(s)
Efficacy (DAS Score, ACR response) [Time Frame: every 2 months]
Side effects [Time Frame: every visit]
Secondary ID(s)
CIERA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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