RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis
NCT ID: NCT03016260
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
250 participants
OBSERVATIONAL
2016-12-31
2019-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infliximab (Remicade®)
Infliximab
Anti-TNF alpha originator
Adalimumab (Humira®)
Adalimumab
Anti-TNF alpha originator
Etanercept (Enbrel®)
Etanercept
Anti-TNF alpha originator
Golimumab (Simponi®)
Golimumab
Anti-TNF alpha originator
Certolizumab Pegol (Cimzia®)
Certolizumab Pegol
Anti-TNF alpha originator
Infliximab biosimilar (Remsima®/ Inflectra®)
Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
Etanercept biosimilar (Benepali®)
Etanercept biosimilar
Anti-TNF alpha Etanercept biosimilar
Infliximab biosimilar (Flixabi®)
Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar
Interventions
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Infliximab
Anti-TNF alpha originator
Adalimumab
Anti-TNF alpha originator
Etanercept
Anti-TNF alpha originator
Golimumab
Anti-TNF alpha originator
Certolizumab Pegol
Anti-TNF alpha originator
Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
Etanercept biosimilar
Anti-TNF alpha Etanercept biosimilar
Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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European Commission
OTHER
TcLand Expression S.A.
INDUSTRY
Responsible Party
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Locations
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Institute of Rheumatology
Prague, , Czechia
CHU-Montpellier
Montpellier, , France
CHU Nice
Nice, , France
CHU Strasbourg Hautepierre
Strasbourg, , France
Tel Aviv Surasky Medical Center
Tel Aviv, , Israel
Leiden University Medical Center
Leiden, , Netherlands
Istanbul University
Istanbul, , Turkey (Türkiye)
University of Marmara
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2016-A00556-45
Identifier Type: -
Identifier Source: org_study_id