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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396747

Enrollment

Registered

2006-11-07

Start date

2003-06-30

Completion date

2005-09-30

Last updated

2007-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

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

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.

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.

Interventions

DRUGInfliximab, methylprednisolone, methotrexate

DRUGMethotrexate

DRUGMethotrexate + Methylprednisolone

DRUGMethotrexate + Infliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
MRI synovitis, bone edema and erosions score	baseline, week 18 and 52

Secondary

Measure	Time frame
Efficacy (DAS Score, ACR response)	every 2 months
Side effects	every visit

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026