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
Conditions
Interventions
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 o
Sponsors
Saint-Luc Universitary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of UA Absence of ACR criteria Active UA defined by a swollen joint count = 1 and 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
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 |
|---|---|
| Main Objective: To compare the induction therapy with infliximab versus placebo on the synovitis and MRI score in undifferentiated arthritis. ;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. ;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. | — |
Countries
Belgium
Outcome results
None listed