Clinical trial NCT03016260: RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis
Official title: Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFα and Methotrexate Combination.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: RheumatoId Arthritis
Keywords: Rheumatoid Arthritis
Anti TNF
Infliximab
Adalimumab
Etanercept
Golimumab
Certolizumab Pegol
Infliximab biosimilar
Etanercept biosimilar
Methotrexate
Lead sponsor: TcLand Expression S.A.
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2017-01-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from rheumatoid arthritis eligible for biologic therapy, for whom the rheumatologist envisages anyone of anti-TNFα, will be included in this study. As the study should not modify patient care, it is not authorized to prescribe study biologics if other biologic is considered for a given patient or if a given patient is not eligible for study biologic treatment.

Brief summary: RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate combination therapy.

Detailed description: Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between (a) 12 and 14 weeks and (b) 22 and 24 weeks.

The RABIOPRED test is indicated for use in patients:

* 18 years of age or older,
* Eligible for a first line biologic therapy with anti-TNF alpha. The RABIOPRED test is indicated for use by rheumatologists as a biological basis for guiding anti-TNF alpha treatment prior to its initiation.

Eligibility criteria: Inclusion Criteria:

* Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria (Arnett FC, 1988, Arthritis Rheum)
* Patient with a DAS28 index greater than 3.2.
* Patient eligible for treatment with an anti-TNFα agent (any one of Remicade®, Humira®, Enbrel®, Simponi®, Cimzia®, Remsima®/Inflectra®, Benepali® and Flixabi® according to the "Summary of Product Characteristics" for each product) and Methotrexate combination therapy,
* 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 anti-TNFα treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the anti-TNFα therapy. In case of Leflunomide treatment, patients may be included in the study after a period of at least 3 months of Leflunomide stop, or after a washout by cholestyramine for at least 11 days.
* Use of oral steroids (≤ 10 mg/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 anti-TNFα therapy
* Patient (male or female) at 18 years of age or older at inclusion,
* Negative β-HCG (Human Chorionic Gonadotrophin) pregnancy test, when appropriate, according to the patient's age and contraceptive method.
* Written Informed consent signed from the patient.

Exclusion Criteria:

* Patient having received previously any anti-TNFα biologic therapy or any molecule in development belonging to anti-TNFα class. Patients having received other biologics (such as anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development) can be included in the study after a period of at least 6 months,
* Patient non eligible to anti-TNFα according to the SmPC (Summary of Products),
* Patient on anti-TNFα monotherapy without methotrexate,
* Patient with clinically significant, severe and uncontrolled infectious diseases,
* Patient with symptoms of a significant somatic or psychiatric/mental illness,
* Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc.),
* Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the Investigator, may interfere with the study,
* Cancer,
* Pregnancy,
* Nursing mothers,
* Patient who is participating in a clinical trial of other biologics or for whom a period of exclusion has been defined

Primary outcomes:
measure: EULAR response criteria
timeFrame: 13th week (+/- 7 days)
Secondary outcomes:
measure: ACR response criteria
timeFrame: 13th week (+/- 7 days)
measure: EULAR response criteria
timeFrame: 23rd week (+/- 7 days) or at the time of treatment switch
measure: SDAI (Simplified Disease Activity Index) score
timeFrame: 23rd week (+/- 7 days) or at the time of treatment switch
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of Rheumatology
city: Montpellier
country: France
facility: CHU-Montpellier
city: Nice
country: France
facility: CHU Nice
city: Strasbourg
country: France
facility: CHU Strasbourg Hautepierre
city: Tel Aviv
country: Israel
facility: Tel Aviv Surasky Medical Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Istanbul
country: Turkey
facility: Istanbul University
city: İstanbul
country: Turkey
facility: University of Marmara
Study officials:
References: