Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy (PRINT)
Study Design & Objectives:
Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.
To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.
Ancillary study objective:
To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy|
- To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy. [ Time Frame: Performed at inclusion : blood samples will be taken before the infliximab infusion. ] [ Designated as safety issue: No ]Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.
- Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria [ Time Frame: at the time of the first response evaluation (between the 12th and the 14th week) ] [ Designated as safety issue: No ]A statistical analysis will be performed in order to evaluate the predictive performances of the test validated in the study primary objective in relation to the non-response to infliximab and methotrexate combination therapy evaluated according to ACR criteria.
Biospecimen Retention: Samples With DNA
Whole blood sampling in Paxgene tubes (DNA, RNA) Whole blood sampling in EDTA tubes
|Study Start Date:||February 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
a single group of patients -200 expected
polyarthrite rhumatoid patients
The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
The RA-INF-Dx test is indicated for use in patients:
- 18 years of age or older,
- Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299545
Show 37 Study Locations
|Principal Investigator:||Sara MARSAL, MD||University Hospital Val d'Hebron (Barcelona, Spain)|