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RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis — RABIOPRED  

RheumatoId Arthritis Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03016260
Study type Observational
Source TcLand Expression S.A.
Contact
Status Terminated
Phase
Start date December 2016
Completion date December 20, 2019
View Details
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