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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Infliximab, methylprednisolone, methotrexate
* Drug: Methotrexate
* Drug: Methotrexate + Methylprednisolone
* Drug: Methotrexate + Infliximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Methotrexate | Drug: Infliximab, methylprednisolone, methotrexate<br> <br> Drug: Methotrexate<br> <br> |
| Active Comparator: B<br>MTX + MP | Drug: Infliximab, methylprednisolone, methotrexate<br> <br> Drug: Methotrexate + Methylprednisolone<br> <br> |
| Active Comparator: C<br>MTX + IFX | Drug: Infliximab, methylprednisolone, methotrexate<br> <br> Drug: Methotrexate + Infliximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI synovitis, bone edema and erosions score |  | baseline, week 18 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (DAS Score, ACR response) |  | every 2 months | 
| Side effects |  | every visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early rheumatoid arthritis,, glucocorticoids,, pulse therapy,, infliximab,, TNF blockade