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

December 21, 2019 updated by: TcLand Expression S.A.

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • Institute of Rheumatology
  • France
      • Montpellier, France
        • CHU-Montpellier
      • Nice, France
        • CHU Nice
      • Strasbourg, France
        • CHU Strasbourg Hautepierre
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Surasky Medical Center
  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Turkey
      • Istanbul, Turkey
        • Istanbul University
      • İstanbul, Turkey
        • University of Marmara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from rheumatoid arthritis eligible for biologic therapy, for whom the rheumatologist envisages anyone of anti-TNFα, will be included in this study. As the study should not modify patient care, it is not authorized to prescribe study biologics if other biologic is considered for a given patient or if a given patient is not eligible for study biologic treatment.

Description

Inclusion Criteria:

  • Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria (Arnett FC, 1988, Arthritis Rheum)
  • Patient with a DAS28 index greater than 3.2.
  • Patient eligible for treatment with an anti-TNFα agent (any one of Remicade®, Humira®, Enbrel®, Simponi®, Cimzia®, Remsima®/Inflectra®, Benepali® and Flixabi® according to the "Summary of Product Characteristics" for each product) and Methotrexate combination therapy,
  • 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 anti-TNFα treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the anti-TNFα therapy. In case of Leflunomide treatment, patients may be included in the study after a period of at least 3 months of Leflunomide stop, or after a washout by cholestyramine for at least 11 days.
  • Use of oral steroids (≤ 10 mg/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 anti-TNFα therapy
  • Patient (male or female) at 18 years of age or older at inclusion,
  • Negative β-HCG (Human Chorionic Gonadotrophin) pregnancy test, when appropriate, according to the patient's age and contraceptive method.
  • Written Informed consent signed from the patient.

Exclusion Criteria:

  • Patient having received previously any anti-TNFα biologic therapy or any molecule in development belonging to anti-TNFα class. Patients having received other biologics (such as anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development) can be included in the study after a period of at least 6 months,
  • Patient non eligible to anti-TNFα according to the SmPC (Summary of Products),
  • Patient on anti-TNFα monotherapy without methotrexate,
  • Patient with clinically significant, severe and uncontrolled infectious diseases,
  • Patient with symptoms of a significant somatic or psychiatric/mental illness,
  • Patient with other auto-immune diseases (i.e. Inflammatory Bowel Diseases, Systemic Lupus Erythematosus, vasculitis, uncontrolled asthma, etc.),
  • Patient with evidence of cardiac, pulmonary, metabolic, renal, hepatic, gastro-intestinal conditions, which, in the opinion of the Investigator, may interfere with the study,
  • Cancer,
  • Pregnancy,
  • Nursing mothers,
  • Patient who is participating in a clinical trial of other biologics or for whom a period of exclusion has been defined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infliximab (Remicade®)
Biological: Infliximab
Anti-TNF alpha originator
Other Names:
  • Remicade®
Adalimumab (Humira®)
Biological: Adalimumab
Anti-TNF alpha originator
Other Names:
  • Humira®
Etanercept (Enbrel®)
Biological: Etanercept
Anti-TNF alpha originator
Other Names:
  • Enbrel®
Golimumab (Simponi®)
Biological: Golimumab
Anti-TNF alpha originator
Other Names:
  • Simponi®
Certolizumab Pegol (Cimzia®)
Biological: Certolizumab Pegol
Anti-TNF alpha originator
Other Names:
  • Cimzia®
Infliximab biosimilar (Remsima®/ Inflectra®)
Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
Other Names:
  • Remsima® or Inflectra®
Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar
Other Names:
  • Flixabi®
Etanercept biosimilar (Benepali®)
Biological: Etanercept biosimilar
Anti-TNF alpha Etanercept biosimilar
Other Names:
  • Benepali®
Infliximab biosimilar (Flixabi®)
Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
Other Names:
  • Remsima® or Inflectra®
Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar
Other Names:
  • Flixabi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EULAR response criteria
Time Frame: 13th week (+/- 7 days)
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on the EULAR (EUropean League Against Rheumatism) response criteria at 13th week (+/- 7 days) compared with baseline.
13th week (+/- 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR response criteria
Time Frame: 13th week (+/- 7 days)
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on ACR (American College of Rheumatology) response criteria at 13th week (+/- 7 days) compared with baseline.
13th week (+/- 7 days)
EULAR response criteria
Time Frame: 23rd week (+/- 7 days) or at the time of treatment switch
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on the EULAR (EUropean League Against Rheumatism) response criteria at 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first) compared with baseline.
23rd week (+/- 7 days) or at the time of treatment switch
SDAI (Simplified Disease Activity Index) score
Time Frame: 23rd week (+/- 7 days) or at the time of treatment switch
Performance of RABIOPRED test to predict treatment response of anti-TNFα agents based on achieving Low Disease Activity (LDA) according to SDAI score at 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first) compared with baseline.
23rd week (+/- 7 days) or at the time of treatment switch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TcLand Expression S.A.

Collaborators

European Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 21, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00556-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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