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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245361
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : October 31, 2013
Information provided by (Responsible Party):
Patrick Durez, Université Catholique de Louvain

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Undifferentiated Arthritis Drug: Infliximab Drug: sodium chloride Not Applicable

Detailed Description:
not necessary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: "A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001".
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Infliximab
Group I: Infliximab 3 mg/kg wk 0,2,6
Drug: Infliximab
Infliximab 3 mg/kg wk 0,2,6
Other Name: FR-BR7794

Placebo Comparator: sodium chloride
RA 1 solution for infusion, intravenous use Sterile normal saline 0.9% sodium chloride
Drug: sodium chloride
Group II : Placebo wk 0,2,6

Primary Outcome Measures :
  1. Primary objective To compare the induction therapy with infliximab versus placebo on the MRI synovitis and erosion score in undifferentiated arthritis. [ Time Frame: 2 years ]
    not necessary

Secondary Outcome Measures :
  1. To test the hypothesis that induction therapy with infliximab is followed by a better clinical outcome over a 2 year follow-up and defined as a lower rate of patients with ACR criteria at 6, 12 and 24 months. [ Time Frame: 2 years ]
    no necessary

  2. To assess the effects of infliximab on synovial histopathology of UA. [ Time Frame: 2 years ]
    no necessary

  3. To test the hypothesis that infliximab can influence the presence of anti CCP antibodies. [ Time Frame: 2 years ]
    no necessary

  4. To assess physical function and health-related quality of life using the Disability Index of HAQ (HAQ) and questionnaire "SF-36" instruments, respectively [ Time Frame: 2 years ]
    no necessary

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245361

Université Catholique de Louvain
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Patrick Durez
Principal Investigator: Patrick Durez, Md Université Catholique de Louvain

Responsible Party: Patrick Durez, Professor, Université Catholique de Louvain Identifier: NCT01245361     History of Changes
Other Study ID Numbers: P1200/001
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Patrick Durez, Université Catholique de Louvain:
Undifferentiated Arthritis
Rheumatoid Arthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents