RheumatoId ArthritisRABIOPREDNCT03016260
RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis
An observational study of RheumatoId Arthritis, run by TcLand Expression S.A. at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RheumatoId Arthritis
- What is being tested?
- Infliximab, Adalimumab and Etanercept
- How many people
- 250 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Dec 2016to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.),
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
France3 sites
CHU-Montpellier
Montpellier
CHU Nice
Nice
CHU Strasbourg Hautepierre
Strasbourg
Turkey (Türkiye)2 sites
Istanbul University
Istanbul
University of Marmara
Istanbul
About this study
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.
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.
Read the 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.
- Conditions
- RheumatoId Arthritis
- Being tested
- Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab Pegol
- Keywords
- Rheumatoid Arthritis, Anti TNF, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab Pegol, Infliximab biosimilar, Etanercept biosimilar, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Remicade®
Anti-TNF alpha originator
AdalimumabBiological
Also called Humira®
Anti-TNF alpha originator
EtanerceptBiological
Also called Enbrel®
Anti-TNF alpha originator
GolimumabBiological
Also called Simponi®
Anti-TNF alpha originator
Certolizumab PegolBiological
Also called Cimzia®
Anti-TNF alpha originator
Infliximab biosimilarBiological
Also called Remsima® or Inflectra®
Anti-TNF alpha Infliximab biosimilars
Etanercept biosimilarBiological
Also called Benepali®
Anti-TNF alpha Etanercept biosimilar
Infliximab biosimilarBiological
Also called Flixabi®
Anti-TNF alpha Infliximab biosimilar
| Study group | Role | What they receive |
|---|---|---|
| Infliximab (Remicade®) | Not described Receives: Biological: Infliximab | |
| Adalimumab (Humira®) | Not described Receives: Biological: Adalimumab | |
| Etanercept (Enbrel®) | Not described Receives: Biological: Etanercept | |
| Golimumab (Simponi®) | Not described Receives: Biological: Golimumab | |
| Certolizumab Pegol (Cimzia®) | Not described Receives: Biological: Certolizumab Pegol | |
| Infliximab biosimilar (Remsima®/ Inflectra®) | Not described Receives: Biological: Infliximab biosimilar | |
| Etanercept biosimilar (Benepali®) | Not described Receives: Biological: Etanercept biosimilar | |
| Infliximab biosimilar (Flixabi®) | Not described Receives: Biological: Infliximab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13th week (+/- 7 days)
Secondary outcomes (3)
ACR response criteria
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.
Measured: 13th week (+/- 7 days)
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 23rd week (+/- 7 days) or at the time of treatment switch (whichever comes first) compared with baseline.
Measured: 23rd week (+/- 7 days) or at the time of treatment switch
SDAI (Simplified Disease Activity Index) score
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.
Measured: 23rd week (+/- 7 days) or at the time of treatment switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheumatoId ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- TcLand Expression S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016260
- Sponsor's protocol ID
- 2016-A00556-45
- Acronym
- RABIOPRED
- Status last verified
- Dec 2019
- First submitted
- 4 Jan 2017
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03016260
- Acronym / sponsor ID
- RABIOPRED / 2016-A00556-45
- Conditions
- RheumatoId Arthritis
- Keywords
- Rheumatoid Arthritis, Anti TNF, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab Pegol, Infliximab biosimilar
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 250 participants (actual)
- Lead sponsor
- TcLand Expression S.A.Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- Dec 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: Remicade®Anti-TNF alpha originator | Biological | Infliximab (Remicade®) |
| AdalimumabAlso: Humira®Anti-TNF alpha originator | Biological | Adalimumab (Humira®) |
| EtanerceptAlso: Enbrel®Anti-TNF alpha originator | Biological | Etanercept (Enbrel®) |
| GolimumabAlso: Simponi®Anti-TNF alpha originator | Biological | Golimumab (Simponi®) |
| Certolizumab PegolAlso: Cimzia®Anti-TNF alpha originator | Biological | Certolizumab Pegol (Cimzia®) |
| Infliximab biosimilarAlso: Remsima® or Inflectra®Anti-TNF alpha Infliximab biosimilars | Biological | Infliximab biosimilar (Remsima®/ Inflectra®) |
| Etanercept biosimilarAlso: Benepali®Anti-TNF alpha Etanercept biosimilar | Biological | Etanercept biosimilar (Benepali®) |
| Infliximab biosimilarAlso: Flixabi®Anti-TNF alpha Infliximab biosimilar | Biological | Infliximab biosimilar (Flixabi®) |
Primary outcome
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.
3 secondary outcomes
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
SDAI (Simplified Disease Activity Index) score
Time frame: 23rd week (+/- 7 days) or at the time of treatment switch
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Related trials for RheumatoId Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RheumatoId Arthritis, run by TcLand Expression S.A. at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Turkey (Türkiye), Czechia, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EULAR response criteria (time frame: 13th week (+/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.