Clinical trial NCT01245361: A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undifferentiated Arthritis
Keywords: Undifferentiated Arthritis
Rheumatoid Arthritis
Infliximab
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: not necessary

Eligibility 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

Primary outcomes:
measure: Primary objective To compare the induction therapy with infliximab versus placebo on the MRI synovitis and erosion score in undifferentiated arthritis.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
measure: To assess the effects of infliximab on synovial histopathology of UA.
timeFrame: 2 years
measure: To test the hypothesis that infliximab can influence the presence of anti CCP antibodies.
timeFrame: 2 years
measure: To assess physical function and health-related quality of life using the Disability Index of HAQ (HAQ) and questionnaire "SF-36" instruments, respectively
timeFrame: 2 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Université Catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Patrick Durez, Md
role: PRINCIPAL_INVESTIGATOR
References: