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A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

NCT ID: NCT01245361

Last Updated: 2013-10-31

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-12-31

Brief Summary

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Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP) antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a higher rate of erosion and a higher risk of progressive and severe RA.

The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more effective.

The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial studies from patients with early arthritis suggest that UA and RA may share common immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early arthritis demonstrates synovitis in more than half of the joints samples with prominent T cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).

Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence the clinical outcome.

Recently, Methotrexate has been demonstrated to improve the course of undifferentiated arthritis and prevent the development of RA. Short regimen of more intensive therapy with Infliximab could alter the radiological, immunopathological and clinical outcome.

Detailed Description

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not necessary

Conditions

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Undifferentiated Arthritis

Keywords

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Undifferentiated Arthritis Rheumatoid Arthritis Infliximab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Infliximab

Group I: Infliximab 3 mg/kg wk 0,2,6

Group Type EXPERIMENTAL

Infliximab

Intervention Type DRUG

Infliximab 3 mg/kg wk 0,2,6

sodium chloride

RA 1 solution for infusion, intravenous use Sterile normal saline 0.9% sodium chloride

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DRUG

Group II : Placebo wk 0,2,6

Interventions

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Infliximab

Infliximab 3 mg/kg wk 0,2,6

Intervention Type DRUG

sodium chloride

Group II : Placebo wk 0,2,6

Intervention Type DRUG

Other Intervention Names

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FR-BR7794

Eligibility Criteria

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Inclusion Criteria

Diagnosis of UA Absence of American College of Rheumatology (ACR) criteria Active UA defined by a swollen joint count ≥ 1 and \< 4 Positive anti-CCP Disease duration \< 2 years DMARDs naive No chronic treatment with steroids (\> 3 months), if needed washout of 4 weeks NSAIDs stable

Exclusion Criteria

Other rheumatic inflammatory diagnosis Contraindication to MRI (pace-maker, etc.) Congestive heart disease Active or latent tuberculosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patrick Durez

OTHER

Sponsor Role lead

Responsible Party

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Patrick Durez

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Other Identifiers

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P1200/001

Identifier Type: -

Identifier Source: org_study_id