Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy

Inclusion Criteria

• •Diagnosis of Rheumatoid Arthritis
• •1. Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.
• •Disease Activity
• •2. Patient with a DAS28 greater than 3.2.
• •Treatment
• •3. Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
• •4. Patient refractory to treatment with at least one classical DMARDs (one of which has to be MTX) prescribed according to the international recommendations, i.e. for at least 12 weeks at the maximal tolerated dose prior to infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),
• •5. Use of oral steroids (≤ 10mg/day of prednisone or equivalent dose of another molecule) and/or NSAIDs will be permitted; doses must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy,
• •Other criteria
• •6. Patient (male or female) at 18 years of age or older at inclusion,
• •7. Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
• •8. Informed consent signed.