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

NCT03016260 | Terminated DMC

• 1 other identifier: 2016-A00556-45
• Study Type: observational
• Target: 250
• Locations: 5 countries
• Sites: 8

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.

Conditions

RheumatoId Arthritis

Keywords

Rheumatoid Arthritis; Anti TNF; Infliximab; Adalimumab; Etanercept; Golimumab; Certolizumab Pegol; Infliximab biosimilar; Etanercept biosimilar; Methotrexate

Outcome Measures

Primary Outcomes (1)

• EULAR response criteria

  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 Outcomes (3)

• ACR response criteria

  13th week (+/- 7 days)

• EULAR response criteria

  23rd week (+/- 7 days) or at the time of treatment switch

• SDAI (Simplified Disease Activity Index) score

  23rd week (+/- 7 days) or at the time of treatment switch

Study Arms (8)

Infliximab (Remicade®)

Biological: Infliximab

Adalimumab (Humira®)

Biological: Adalimumab

Etanercept (Enbrel®)

Biological: Etanercept

Golimumab (Simponi®)

Biological: Golimumab

Certolizumab Pegol (Cimzia®)

Biological: Certolizumab Pegol

Infliximab biosimilar (Remsima®/ Inflectra®)

Biological: Infliximab biosimilar

Etanercept biosimilar (Benepali®)

Biological: Etanercept biosimilar

Infliximab biosimilar (Flixabi®)

Biological: Infliximab biosimilar

Interventions

Infliximab BIOLOGICAL

Anti-TNF alpha originator

Also known as: Remicade®

Infliximab (Remicade®)

Adalimumab BIOLOGICAL

Anti-TNF alpha originator

Also known as: Humira®

Adalimumab (Humira®)

Etanercept BIOLOGICAL

Anti-TNF alpha originator

Also known as: Enbrel®

Etanercept (Enbrel®)

Golimumab BIOLOGICAL

Anti-TNF alpha originator

Also known as: Simponi®

Golimumab (Simponi®)

Certolizumab Pegol BIOLOGICAL

Anti-TNF alpha originator

Also known as: Cimzia®

Certolizumab Pegol (Cimzia®)

Infliximab biosimilar BIOLOGICAL

Anti-TNF alpha Infliximab biosimilars

Also known as: Remsima® or Inflectra®

Infliximab biosimilar (Remsima®/ Inflectra®)

Etanercept biosimilar BIOLOGICAL

Anti-TNF alpha Etanercept biosimilar

Also known as: Benepali®

Etanercept biosimilar (Benepali®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• TcLand Expression S.A.: lead
• European Commission: collaborator

Study Sites (8)

Institute of Rheumatology

Prague, Czechia

Location

CHU-Montpellier

Montpellier, France

Location

CHU Nice

Nice, France

Location

CHU Strasbourg Hautepierre

Strasbourg, France

Location

Tel Aviv Surasky Medical Center

Tel Aviv, Israel

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Istanbul University

Istanbul, Turkey (Türkiye)

Location

University of Marmara

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, Plasma, Serum, PBMC and Urine

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; Adalimumab; Etanercept; golimumab; Certolizumab Pegol; CT-P13; etanercept biosimilar SB4

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 10, 2017
• Study Start: December 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

CZ (1); FR (3); NL (1); TU (2); IL (1)