NCT00396747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
Last Updated

October 19, 2007

Status Verified

October 1, 2007

First QC Date

November 6, 2006

Last Update Submit

October 18, 2007

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • MRI synovitis, bone edema and erosions score

    baseline, week 18 and 52

Secondary Outcomes (2)

  • Efficacy (DAS Score, ACR response)

    every 2 months

  • Side effects

    every visit

Study Arms (3)

A

ACTIVE COMPARATOR

Methotrexate

Drug: Infliximab, methylprednisolone, methotrexateDrug: Methotrexate

B

ACTIVE COMPARATOR

MTX + MP

Drug: Infliximab, methylprednisolone, methotrexateDrug: Methotrexate + Methylprednisolone

C

ACTIVE COMPARATOR

MTX + IFX

Drug: Infliximab, methylprednisolone, methotrexateDrug: Methotrexate + Infliximab

Interventions

Infliximab, methylprednisolone, methotrexateDRUG
ABC
MethotrexateDRUG
A
Methotrexate + MethylprednisoloneDRUG
B
Methotrexate + InfliximabDRUG
C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université catholique de Louvain

Brussels, 1200, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 18050189DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

InfliximabMethylprednisoloneMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Patrick Durez, MD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

June 1, 2003

Study Completion

September 1, 2005

Last Updated

October 19, 2007

Record last verified: 2007-10

Locations

BE(1)