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

NCT01245361 | Completed

• 1 other identifier: P1200/001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Undifferentiated Arthritis

Keywords

Undifferentiated Arthritis; Rheumatoid Arthritis; Infliximab

Outcome Measures

Primary Outcomes (1)

• Primary objective To compare the induction therapy with infliximab versus placebo on the MRI synovitis and erosion score in undifferentiated arthritis.

  not necessary

  2 years

Secondary Outcomes (4)

• 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

• To assess the effects of infliximab on synovial histopathology of UA.

  2 years

• To test the hypothesis that infliximab can influence the presence of anti CCP antibodies.

  2 years

• 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

Study Arms (2)

Infliximab

EXPERIMENTAL

Group I: Infliximab 3 mg/kg wk 0,2,6

Drug: Infliximab

sodium chloride

PLACEBO COMPARATOR

RA 1 solution for infusion, intravenous use Sterile normal saline 0.9% sodium chloride

Drug: sodium chloride

Interventions

Infliximab DRUG

Infliximab 3 mg/kg wk 0,2,6

Also known as: FR-BR7794

Infliximab

sodium chloride DRUG

Group II : Placebo wk 0,2,6

sodium chloride

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other rheumatic inflammatory diagnosis Contraindication to MRI (pace-maker, etc.) Congestive heart disease Active or latent tuberculosis

Sponsors & Collaborators

• Patrick Durez: lead

Study Sites (1)

Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Patrick Durez, Md

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

BE (1)