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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:
ClinicalTrials.gov Identifier:
NCT01245361
First Posted: November 22, 2010
Last Update Posted: October 31, 2013
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.
Information provided by (Responsible Party):
Patrick Durez, Université Catholique de Louvain
November 19, 2010
November 22, 2010
October 31, 2013
November 2007
December 2011   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01245361 on ClinicalTrials.gov Archive Site
  • 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
  • To assess the effects of infliximab on synovial histopathology of UA. [ Time Frame: 2 years ]
    no necessary
  • To test the hypothesis that infliximab can influence the presence of anti CCP antibodies. [ Time Frame: 2 years ]
    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 ]
    no necessary
  • 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
  • To assess the effects of infliximab on synovial histopathology of UA. [ Time Frame: 2 years ]
    no necessary
  • To test the hypothesis that infliximab can influence the presence of anti CCP antibodies. [ Time Frame: 2 years ]
    no necessary
  • To assess physical function and health-related quality of life using the Disability Index of HAQ (HAQ) and SF-36 instruments, respectively [ Time Frame: 2 years ]
    no necessary
Not Provided
Not Provided
 
A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit
"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".

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.

not necessary
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Undifferentiated Arthritis
  • Drug: Infliximab
    Infliximab 3 mg/kg wk 0,2,6
    Other Name: FR-BR7794
  • Drug: sodium chloride
    Group II : Placebo wk 0,2,6
  • Experimental: Infliximab
    Group I: Infliximab 3 mg/kg wk 0,2,6
    Intervention: Drug: Infliximab
  • Placebo Comparator: sodium chloride
    RA 1 solution for infusion, intravenous use Sterile normal saline 0.9% sodium chloride
    Intervention: Drug: sodium chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
December 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01245361
P1200/001
No
Not Provided
Not Provided
Patrick Durez, Université Catholique de Louvain
Patrick Durez
Not Provided
Principal Investigator: Patrick Durez, Md Université Catholique de Louvain
Université Catholique de Louvain
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP