NCT00396747

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Infliximab, methylprednisolone, methotrexate
DRUG	Methotrexate
DRUG	Methotrexate + Methylprednisolone
DRUG	Methotrexate + Infliximab

Timeline

• Start date: 2003-06-01
• Completion: 2005-09-01
• First posted: 2006-11-07
• Last updated: 2007-10-19

Locations

1 site across 1 country: Belgium