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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01245361
Date of registration: 19/11/2010
Prospective Registration: No
Primary sponsor: Patrick Durez
Public title: A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit UA-IFX
Scientific 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".
Date of first enrolment: November 2007
Target sample size: 30
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01245361
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Belgium
Contacts
Name:     Patrick Durez, Md
Address: 
Telephone:
Email:
Affiliation:  Universit├ę Catholique de Louvain
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Undifferentiated Arthritis
Intervention(s)
Drug: Infliximab
Drug: sodium chloride
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
To assess the effects of infliximab on synovial histopathology of UA. [Time Frame: 2 years]
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]
To test the hypothesis that infliximab can influence the presence of anti CCP antibodies. [Time Frame: 2 years]
Secondary ID(s)
P1200/001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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