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

RheumatoId Arthritis Clinical Trial

— RABIOPRED  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03016260
• Other study ID #: 2016-A00556-45
• Status: Terminated
• Start date: December 2016
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2019
• Source: TcLand Expression S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-TNFa 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-TNFa treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the anti-TNFa 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-TNFa therapy

• Patient (male or female) at 18 years of age or older at inclusion,

• Negative ß-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-TNFa biologic therapy or any molecule in development belonging to anti-TNFa 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-TNFa according to the SmPC (Summary of Products),

• Patient on anti-TNFa 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• RheumatoId Arthritis

Intervention

Biological:
• Infliximab
Anti-TNF alpha originator
• Adalimumab
Anti-TNF alpha originator
• Etanercept
Anti-TNF alpha originator
• Golimumab
Anti-TNF alpha originator
• Certolizumab Pegol
Anti-TNF alpha originator
• Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilars
• Etanercept biosimilar
Anti-TNF alpha Etanercept biosimilar
• Infliximab biosimilar
Anti-TNF alpha Infliximab biosimilar

Locations

Country	Name	City	State
Czechia	Institute of Rheumatology	Prague
France	CHU-Montpellier	Montpellier
France	CHU Nice	Nice
France	CHU Strasbourg Hautepierre	Strasbourg
Israel	Tel Aviv Surasky Medical Center	Tel Aviv
Netherlands	Leiden University Medical Center	Leiden
Turkey	Istanbul University	Istanbul
Turkey	University of Marmara	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
TcLand Expression S.A.	European Commission

Countries where clinical trial is conducted

Czechia,  France,  Israel,  Netherlands,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EULAR response criteria	Performance of RABIOPRED test to predict treatment response of anti-TNFa agents based on the EULAR (EUropean League Against Rheumatism) response criteria at 13th week (+/- 7 days) compared with baseline.	13th week (+/- 7 days)
Secondary	ACR response criteria	Performance of RABIOPRED test to predict treatment response of anti-TNFa agents based on ACR (American College of Rheumatology) response criteria at 13th week (+/- 7 days) compared with baseline.	13th week (+/- 7 days)
Secondary	EULAR response criteria	Performance of RABIOPRED test to predict treatment response of anti-TNFa 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
Secondary	SDAI (Simplified Disease Activity Index) score	Performance of RABIOPRED test to predict treatment response of anti-TNFa 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