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Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy

NCT01299545 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2013-02-01

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Theradis pharma

    collaborator UNKNOWN

  • Medpharmgene, Inc.

    collaborator INDUSTRY

  • TcLand Expression S.A.

    lead INDUSTRY

Principal Investigators

  • Sara MARSAL, MD · University Hospital Val d'Hebron (Barcelona, Spain)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Canada
  • France
  • Hungary
  • Italy
  • Lithuania
  • Romania
  • Slovakia
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299545 on ClinicalTrials.gov