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

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ClinicalTrials.gov Identifier: NCT01299545
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : February 18, 2011
Last Update Posted : February 1, 2013
Sponsor:
Collaborators:
Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.
Information provided by (Responsible Party):
TcLand Expression S.A.

Tracking Information
First Submitted Date February 16, 2011
First Posted Date February 18, 2011
Last Update Posted Date February 1, 2013
Study Start Date February 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2011)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 16, 2011)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy
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
Brief 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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood sampling in Paxgene tubes (DNA, RNA) Whole blood sampling in EDTA tubes
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.
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts a single group of patients -200 expected
polyarthrite rhumatoid patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 31, 2013)
123
Original Estimated Enrollment
 (submitted: February 16, 2011)
200
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   France,   Hungary,   Italy,   Lithuania,   Romania,   Slovakia,   Spain
Removed Location Countries Slovenia
 
Administrative Information
NCT Number NCT01299545
Other Study ID Numbers 2010-A01046-33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party TcLand Expression S.A.
Study Sponsor TcLand Expression S.A.
Collaborators
  • Premier Research Group plc
  • Theradis pharma
  • Medpharmgene, Inc.
Investigators
Principal Investigator: Sara MARSAL, MD University Hospital Val d'Hebron (Barcelona, Spain)
PRS Account TcLand Expression S.A.
Verification Date January 2013