Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy (PRINT)
|ClinicalTrials.gov Identifier: NCT01299545|
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : February 18, 2011
Last Update Posted : February 1, 2013
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||123 participants|
|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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
a single group of patients -200 expected
polyarthrite rhumatoid patients
- 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. ]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) ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299545
|Principal Investigator:||Sara MARSAL, MD||University Hospital Val d'Hebron (Barcelona, Spain)|