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.
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.
Study Type
OBSERVATIONAL
Enrollment
250
Anti-TNF alpha originator
Anti-TNF alpha originator
Anti-TNF alpha originator
Institute of Rheumatology
Prague, Czechia
CHU-Montpellier
Montpellier, France
CHU Nice
Nice, France
CHU Strasbourg Hautepierre
Strasbourg, France
EULAR response criteria
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on the EULAR (EUropean League Against Rheumatism) response criteria at 13th week (+/- 7 days) compared with baseline.
Time frame: 13th week (+/- 7 days)
ACR response criteria
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on ACR (American College of Rheumatology) response criteria at 13th week (+/- 7 days) compared with baseline.
Time frame: 13th week (+/- 7 days)
EULAR response criteria
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents 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) compared with baseline.
Time frame: 23rd week (+/- 7 days) or at the time of treatment switch
SDAI (Simplified Disease Activity Index) score
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents 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) compared with baseline.
Time frame: 23rd week (+/- 7 days) or at the time of treatment switch
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Anti-TNF alpha originator
Anti-TNF alpha originator
Anti-TNF alpha Infliximab biosimilars
Anti-TNF alpha Etanercept biosimilar
Anti-TNF alpha Infliximab biosimilar
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)