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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: EUCTR
Last refreshed on: 7 October 2014
Main ID:  EUCTR2007-004694-26-BE
Date of registration: 10/09/2007
Prospective Registration: Yes
Primary sponsor: Saint-Luc Universitary Hospital
Public 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 : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA
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 : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA
Date of first enrolment: 17/09/2007
Target sample size: 30
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004694-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Belgium
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Diagnosis of UA
Absence of 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 steroïds (> 3 months), if needed washout of 4 weeks
NSAIDs stable

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -
Pharmaceutical Form: Powder for infusion*
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To compare the induction therapy with infliximab versus placebo on the synovitis and MRI score in undifferentiated arthritis.
Primary end point(s): Primary endpoint :
To compare the induction therapy with infliximab versus placebo on the synovitis and MRI score in undifferentiated arthritis.
The secondary endpoints of the study are as follows:
1.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 an absence of ACR criteria.
2.To test the hypothesis that the effects of infliximab on synovial histology.
3.To test the hypothesis that infliximab can influence the presence of anti CCP antibodies.
Secondary Objective: 1. 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 an absence of ACR criteria.
2. To test the hypothesis that the effects of infliximab on synovial histology.
3. To test the hypothesis that infliximab can influence the presence of anti CCP antibodies.
Secondary Outcome(s)
Secondary ID(s)
P1200/001
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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