Rheumatoid ArthritisPRINTNCT01299545
Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy
An observational study of Rheumatoid Arthritis, run by TcLand Expression S.A. at 37 sites in 8 countries.
Trial summary
Study Design \& Objectives: Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks. To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 123 participants
- Where
- 37 sitesin 8 countries
- Study dates
- Feb 2011to Oct 2012
- 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 RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.
Who may be able to join
- Diagnosis of Rheumatoid Arthritis
- Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.
- Disease Activity
- Patient with a DAS28 greater than 3.2.
- Treatment
- Patient eligible for a first line TNFα blocking agent treatment with infliximab according to the "Summary of Product Characteristics",
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- 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 infliximab treatment and with doses which must have been kept stable during the 4 weeks preceding the initiation of the infliximab therapy (patients may be included if they have undergone a wash-out period using cholestyramine or equivalent subsequent to leflunomide treatment),
- Use of oral steroids (≤ 10mg/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 infliximab therapy,
- Other criteria
- Patient (male or female) at 18 years of age or older at inclusion,
- Negative β-HCG pregnancy test, when appropriate according to the patient's age and contraceptive method,
- Informed consent signed.
Who cannot join
- Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
- Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
- 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,
- Pregnancy,
- Patient that is participating in a clinical trial or that participated in a previous one within 10 weeks prior to study entry.
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
France8 sites
Location n°41
Amiens
Location n°13
Bobigny
Location n°39
Dreux
Location n°14
Grenoble
Location n°40
Meaux
Location n°25
Paris
Location n°37
Paris (Hop Bichat)
Location n°38
Strasbourg
Romania8 sites
Location n° 19
Bucharest
Location n°20
Bucharest
Location n°22
Bucharest
Location n°23
Bucharest
Location n°21
Cluj-Napoca
Location n°24
Iași
Location n°26
Iași
Location n°18
Timișoara
Canada5 sites
Location n°31
Mississauga - Chow
Location n°36
Ontario
Location n°34
Rimouski
Location n°33
Saskatchewan
Location n°35
Toronto
Hungary5 sites
Location n°6
Budapest
Location n°8
Budapest
Location n°7
Debrecen
Location n°10
Eger
Location n°9
Kistarcsa
Lithuania4 sites
Location n°27
Kaunas
Location n°29
Klaipėda
Location n°30
Panevezys
Location n°28
Vilnius
About this study
Official title: Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy
Study Design \& Objectives:
Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.
To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.
Ancillary study objective:
To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.
Read the detailed description
The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
The RA-INF-Dx test is indicated for use in patients:
- 18 years of age or older,
- Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Anti TNF, Infliximab, Methotrexate, DMARDs, Gene expression biomarkers
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a single group of patients -200 expected | polyarthrite rhumatoid patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.
Measured: Performed at inclusion : blood samples will be taken before the infliximab infusion.
Secondary outcomes (1)
Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria
A statistical analysis will be performed in order to evaluate the predictive performances of the test validated in the study primary objective in relation to the non-response to infliximab and methotrexate combination therapy evaluated according to ACR criteria.
Measured: at the time of the first response evaluation (between the 12th and the 14th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Recruitment difficulties
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
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- TcLand Expression S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Theradis pharma, Medpharmgene, Inc.
- Responsible party
- Sponsor
- Investigators
- Sara MARSAL, MD, Principal investigator, University Hospital Val d'Hebron (Barcelona, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299545
- Sponsor's protocol ID
- 2010-A01046-33
- Acronym
- Status last verified
- Jan 2013
- First submitted
- 16 Feb 2011
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy
- ClinicalTrials.gov ID
- NCT01299545
- Acronym / sponsor ID
- PRINT / 2010-A01046-33
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Anti TNF, Infliximab, Methotrexate, DMARDs, Gene expression biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 123 participants (actual)
- Lead sponsor
- TcLand Expression S.A.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Theradis pharma, Medpharmgene, Inc.
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Feb 2011 (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.
Study Design \& Objectives:
Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.
To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.
Ancillary study objective:
To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.
Detailed description
The RA-INF-Dx test is a non invasive in vitro blood test intended to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
The RA-INF-Dx test is indicated for use in patients:
- 18 years of age or older,
- Eligible for a first line biologic therapy with infliximab. The RA-INF-Dx test is indicated for use by rheumatologists as a biological basis for guiding infliximab treatment prior to its initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a single group of patients -200 expected | – | –polyarthrite rhumatoid patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from RA eligible to a first biologic therapy for whom the treating rheumatologist envisages infliximab therapy will be included in this study.
Key inclusion criteria (12 listed)
- Diagnosis of Rheumatoid Arthritis
- Patient with a confirmed Rheumatoid Arthritis according the American College of Rheumatology (ACR) classification criteria.
- Disease Activity
- Patient with a DAS28 greater than 3.2.
- Treatment
Key exclusion criteria (8 listed)
- Patient having received previous courses of other biologic therapy (TNF blocking agents, anti-CD20, anti-CTLA4, IL1 blockers, IL6 blockers and other molecules in development),
- Patient non eligible to infliximab therapy according to the "Summary of Product Characteristics",
- 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...),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy.
Time frame: Performed at inclusion : blood samples will be taken before the infliximab infusion.
Statistical relationship between the RA-INF-Dx blood test results and the non-response (evaluated according to EULAR criteria) to infliximab and methotrexate combination therapy will be analyzed.
1 secondary outcome
Non-response to infliximab and methotrexate combination therapy based on American College of Rheumatology (ACR) criteria
Time frame: at the time of the first response evaluation (between the 12th and the 14th week)
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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.
Sara MARSAL, MD principal investigator
University Hospital Val d'Hebron (Barcelona, Spain)
37 sites in 8 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 37 sites in 8 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 12 inclusion and 8 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 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Romania, Canada, Hungary, Lithuania and 3 more countries. 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 (reason given: Recruitment difficulties). 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?
To determine the performances of the RA-INF-Dx test to aid in the identification of patients with RA who are unlikely to show an initial response to infliximab and methotrexate combination therapy. (time frame: Performed at inclusion : blood samples will be taken before the infliximab infusion.). 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 1 Feb 2013.