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

NCT ID: NCT00396747

Last Updated: 2007-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-09-30

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.

Conditions

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Rheumatoid Arthritis

Keywords

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Early rheumatoid arthritis, glucocorticoids, pulse therapy, infliximab, TNF blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Methotrexate

Group Type ACTIVE_COMPARATOR

Infliximab, methylprednisolone, methotrexate

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

B

MTX + MP

Group Type ACTIVE_COMPARATOR

Infliximab, methylprednisolone, methotrexate

Intervention Type DRUG

Methotrexate + Methylprednisolone

Intervention Type DRUG

C

MTX + IFX

Group Type ACTIVE_COMPARATOR

Infliximab, methylprednisolone, methotrexate

Intervention Type DRUG

Methotrexate + Infliximab

Intervention Type DRUG

Interventions

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Infliximab, methylprednisolone, methotrexate

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Methotrexate + Methylprednisolone

Intervention Type DRUG

Methotrexate + Infliximab

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Principal Investigators

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Patrick Durez, MD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

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Université catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27. doi: 10.1002/art.23055.

Reference Type DERIVED
PMID: 18050189 (View on PubMed)

Other Identifiers

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CIERA

Identifier Type: -

Identifier Source: org_study_id