Altralgia Rheumatoid Arthritis
Conditions
Sponsors
TcLand Expression SA
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Rheumatoid Arthritis 2. Patient with a DAS28 greater than 3.2 3. Patient eligible for treatment with any anti-TNF* agent (any one of Remicade®, Humira®, Enbrel®, Simponi®, Cimzia®, Remsima®/Inflectra®, Benepali® and Flixabi® according to the *Summary of Product Characteristics* for each product) as monotherapy as well as in combination therapies with any classical DMARDs 4. Patient (male or female) at 18 years of age or older at inclusion 5. Written informed consent signed from the patient.
Exclusion criteria
Exclusion criteria: 1.Patient having received previously any anti-TNF* biologic therapy or any molecule in development belonging to anti-TNF* class. 2.Patient non eligible to anti-TNF* therapy according to the *Summary of Product Characteristics* 3.Patient with clinically significant, severe and uncontrolled infectious diseases 4.Patient with other auto-immune diseases 5 Patient with symptoms of a significant somatic or psychiatric/mental illness 6 Cancer 7.Pregnancy 8 Nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Performance of RABIOPRED test to predict treatment efficacy of anti-TNF* agents at baseline based on the EULAR (EUropean League Against Rheumatism) response criteria at 13th week (+/- 7 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * Performance of RABIOPRED test to predict treatment efficacy of anti-TNF* agents at baseline based on ACR (American College of Rheumatology) response criteria at 13th week (+/- 7 days). * Performance of RABIOPRED test to predict treatment efficacy of anti-TNF* agents at baseline based on ACR (American College of Rheumatology) response criteria at 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first). * Performance of RABIOPRED test to predict treatment efficacy of anti-TNF* agents at baseline based on the EULAR (EUropean League Against Rheumatism) response criteria at 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first). * Performance of RABIOPRED test to predict treatment efficacy of anti-TNF* agents at baseline based on achieving Low Disease Activity (LDA) according to SDAI score at 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first). Exploratory endpoint: * Development, maintenance, and utilization of a biorepository of serum, plasma, PBMC, RNA and DNA samples and associated data for additional experiments and analyses | — |
Countries
Czechia, France, Israel, Netherlands, Turkey
Outcome results
None listed