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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03016260
• Date of registration: 04/01/2017
• Prospective Registration: No
• Primary sponsor: TcLand Expression S.A.
• Public title: RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis RABIOPRED
• Scientific 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-TNFa and Methotrexate Combination.
• Date of first enrolment: December 2016
• Target sample size: 250
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03016260
• Study type: Observational

Countries of recruitment

Czech Republic, Czechia, France, Israel, Netherlands, Turkey

Key inclusion & exclusion 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-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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

RheumatoId Arthritis

Intervention(s)

Biological: Etanercept

Biological: Infliximab biosimilar

Biological: Certolizumab Pegol

Biological: Golimumab

Biological: Etanercept biosimilar

Biological: Adalimumab

Biological: Infliximab

Primary Outcome(s)

EULAR response criteria [Time Frame: 13th week (+/- 7 days)]

Secondary Outcome(s)

SDAI (Simplified Disease Activity Index) score [Time Frame: 23rd week (+/- 7 days) or at the time of treatment switch]

ACR response criteria [Time Frame: 13th week (+/- 7 days)]

EULAR response criteria [Time Frame: 23rd week (+/- 7 days) or at the time of treatment switch]

Secondary ID(s)

2016-A00556-45

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Commission