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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Durez, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01245361
First received: November 19, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention
Undifferentiated Arthritis
Drug: Infliximab
Drug: sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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".

Resource links provided by NLM:


Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    not necessary


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    no necessary

  • To assess the effects of infliximab on synovial histopathology of UA. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary

  • To test the hypothesis that infliximab can influence the presence of anti CCP antibodies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    no necessary

  • 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 ] [ Designated as safety issue: No ]
    no necessary


Enrollment: 30
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

not necessary

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245361

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

No publications provided

Responsible Party: Patrick Durez, Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01245361     History of Changes
Other Study ID Numbers: P1200/001
Study First Received: November 19, 2010
Last Updated: October 30, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Université Catholique de Louvain:
Undifferentiated Arthritis
Rheumatoid Arthritis
Infliximab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014