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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396747
• Other study ID #: CIERA
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2006
• Last updated: October 18, 2007
• Start date: June 2003
• Est. completion date: September 2005

Study information

• Verified date: October 2007
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Infliximab, methylprednisolone, methotrexate

• Methotrexate

• Methotrexate + Methylprednisolone

• Methotrexate + Infliximab

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI synovitis, bone edema and erosions score		baseline, week 18 and 52
Secondary	Efficacy (DAS Score, ACR response)		every 2 months
Secondary	Side effects		every visit