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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245361

Acronym

UA-IFX

Enrollment

Registered

2010-11-22

Start date

2007-11-30

Completion date

2012-12-31

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undifferentiated Arthritis

Keywords

Undifferentiated Arthritis, Rheumatoid Arthritis, Infliximab

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

Interventions

DRUGInfliximab

Infliximab 3 mg/kg wk 0,2,6

DRUGsodium chloride

Group II : Placebo wk 0,2,6

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary objective To compare the induction therapy with infliximab versus placebo on the MRI synovitis and erosion score in undifferentiated arthritis.	2 years	not necessary

Secondary

Measure	Time frame	Description
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.	2 years	no necessary
To assess the effects of infliximab on synovial histopathology of UA.	2 years	no necessary
To test the hypothesis that infliximab can influence the presence of anti CCP antibodies.	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	2 years	no necessary

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026