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

Sponsor

Université Catholique de Louvain (Other)

Overall Status

Completed

CT.gov ID

NCT00396747

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate Drug: Methotrexate + Methylprednisolone Drug: Methotrexate + Infliximab	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2003

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Methotrexate	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate
Active Comparator: B MTX + MP	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate + Methylprednisolone
Active Comparator: C MTX + IFX	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate + Infliximab

Arm

Intervention/Treatment

Active Comparator: A

Methotrexate

Drug: Infliximab, methylprednisolone, methotrexate

Drug: Methotrexate

Active Comparator: B

MTX + MP

Drug: Infliximab, methylprednisolone, methotrexate

Drug: Methotrexate + Methylprednisolone

Active Comparator: C

MTX + IFX

Drug: Infliximab, methylprednisolone, methotrexate

Drug: Methotrexate + Infliximab

Outcome Measures

Primary Outcome Measures

MRI synovitis, bone edema and erosions score [baseline, week 18 and 52]

Secondary Outcome Measures

Efficacy (DAS Score, ACR response) [every 2 months]
Side effects [every visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.