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

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ClinicalTrials.gov Identifier: NCT03016260
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
TcLand Expression S.A.

Brief 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.

Condition or disease Intervention/treatment
RheumatoId Arthritis Biological: Infliximab Biological: Adalimumab Biological: Etanercept Biological: Golimumab Biological: Certolizumab Pegol Biological: Infliximab biosimilar Biological: Etanercept biosimilar

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.

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : December 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infliximab (Remicade®) Biological: Infliximab
Anti-TNF alpha originator
Other Name: Remicade®

Adalimumab (Humira®) Biological: Adalimumab
Anti-TNF alpha originator
Other Name: Humira®

Etanercept (Enbrel®) Biological: Etanercept
Anti-TNF alpha originator
Other Name: Enbrel®

Golimumab (Simponi®) Biological: Golimumab
Anti-TNF alpha originator
Other Name: Simponi®

Certolizumab Pegol (Cimzia®) Biological: Certolizumab Pegol
Anti-TNF alpha originator
Other Name: Cimzia®

Infliximab biosimilar (Remsima®/ Inflectra®) Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
Other Name: Remsima® or Inflectra®

Etanercept biosimilar (Benepali®) Biological: Etanercept biosimilar
Anti-TNF alpha Etanercept biosimilar
Other Name: Benepali®

Infliximab biosimilar (Flixabi®) Biological: Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar
Other Name: Flixabi®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
DNA, RNA, Plasma, Serum, PBMC and Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016260


Contacts
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Contact: Madah Mehdi +33 (0) 3 89 91 13 20
Contact: Hüseyin Firat +33 (0) 3 89 91 13 20

Locations
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Czechia
Institute of Rheumatology Recruiting
Prague, Czechia
Contact: Jiří Vencovský         
France
CHU-Montpellier Recruiting
Montpellier, France
Contact: Christian Jorgensen         
CHU Nice Recruiting
Nice, France
Contact: Veronique Breuil         
CHU Strasbourg Hautepierre Recruiting
Strasbourg, France
Contact: Jacques-Eric Gottenberg         
Israel
Tel Aviv Surasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Nadir Arber         
Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Tom Huizinga         
Turkey
Istanbul University Recruiting
Istanbul, Turkey
Contact: Ahmet Gül         
University of Marmara Recruiting
İstanbul, Turkey
Contact: Nevsun Inunç         
Sponsors and Collaborators
TcLand Expression S.A.
European Commission

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Responsible Party: TcLand Expression S.A.
ClinicalTrials.gov Identifier: NCT03016260     History of Changes
Other Study ID Numbers: 2016-A00556-45
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by TcLand Expression S.A.:
Rheumatoid Arthritis
Anti TNF
Infliximab
Adalimumab
Etanercept
Golimumab
Certolizumab Pegol
Infliximab biosimilar
Etanercept biosimilar
Methotrexate
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Methotrexate
Infliximab
Certolizumab Pegol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Gastrointestinal Agents