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

This study has been terminated.
(Recruitment difficulties)
Sponsor:
Collaborators:
Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.
Information provided by (Responsible Party):
TcLand Expression S.A.
ClinicalTrials.gov Identifier:
NCT01299545
First received: February 16, 2011
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by TcLand Expression S.A.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 123
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
a single group of patients -200 expected
polyarthrite rhumatoid patients

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.

Criteria

Inclusion Criteria:

Diagnosis of Rheumatoid Arthritis

  1. Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.

    Disease Activity

  2. Patient with a DAS28 greater than 3.2.

    Treatment

  3. Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
  4. Patient refractory to treatment with at least one classical DMARDs (one of which has to be MTX) prescribed according to the international recommendations, i.e. for at least 12 weeks at the maximal tolerated dose prior to infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),
  5. Use of oral steroids (≤ 10mg/day of prednisone or equivalent dose of another molecule) and/or NSAIDs will be permitted; doses must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy,

    Other criteria

  6. Patient (male or female) at 18 years of age or older at inclusion,
  7. Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
  8. Informed consent signed.

Exclusion Criteria:

  1. Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
  2. Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
  3. Patient with clinically significant, severe and uncontrolled infectious diseases,
  4. Patient with symptoms of a significant somatic or psychiatric/mental illness,
  5. Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc...),
  6. Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the investigator, may interfere with the study,
  7. Pregnancy,
  8. Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299545

  Show 37 Study Locations
Sponsors and Collaborators
TcLand Expression S.A.
Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.
Investigators
Principal Investigator: Sara MARSAL, MD University Hospital Val d'Hebron (Barcelona, Spain)
  More Information

No publications provided

Responsible Party: TcLand Expression S.A.
ClinicalTrials.gov Identifier: NCT01299545     History of Changes
Other Study ID Numbers: 2010-A01046-33
Study First Received: February 16, 2011
Last Updated: January 31, 2013
Health Authority: Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Slovakia: State Institute for Drug Control
Spain: Ethics Committee
Italy: Ethics Committee
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Romania: Ethics Committee
Lithuania: Bioethics Committee
Canada: Ethics Review Committee

Keywords provided by TcLand Expression S.A.:
Rheumatoid Arthritis
Anti TNF
Infliximab
Methotrexate
DMARDs
Gene expression biomarkers

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014