A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Infliximab, methylprednisolone, methotrexate; Drug: Methotrexate + Methylprednisolone; Drug: Methotrexate + Infliximab; Drug: Methotrexate

• Registration Number: NCT00396747
• Lead Sponsor: Université Catholique de Louvain

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 and erosive changes in early rheumatoid arthritis (RA) patients.

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.

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-09
• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Study First Posted: 2006-11-07
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-18
• Last Update Posted: 2007-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Methotrexate + Methylprednisolone	MTX + MP
C	Infliximab, methylprednisolone, methotrexate	MTX + IFX
C	Methotrexate + Infliximab	MTX + IFX
A	Infliximab, methylprednisolone, methotrexate	Methotrexate
A	Methotrexate	Methotrexate
B	Infliximab, methylprednisolone, methotrexate	MTX + MP

Primary Outcome Measures

Name	Time	Method
MRI synovitis, bone edema and erosions score	baseline, week 18 and 52

Secondary Outcome Measures

Name	Time	Method
Efficacy (DAS Score, ACR response)	every 2 months
Side effects	every visit

Trial Locations

Locations (1)

Université catholique de Louvain; 🇧🇪 Brussels, Belgium