Chronic ArthritisNCT02909998
Biomarkers in Chronic Arthritis
An observational study of Chronic Arthritis, run by University Hospital, Montpellier.
Trial summary
Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Chronic Arthritis
- What is being tested?
- Blood sample
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2014
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients referred for chronic arthritis
Who may be able to join
- All patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by GPs questionnaires), physical therapists visits, occupational therapists, psychologists.. etc
Who cannot join
- Patients treated with biological therapy for non rheumatic disease
- Other inflammatory diseases such as Crohn's disease
- Refusal to participate in the collection
About this study
Official title: Evaluation of Predictive Genetic Markers of Response to Biologic Therapies in Chronic Arthritis
Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.
Read the detailed description
Chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. Some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. This study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.
- Conditions
- Chronic Arthritis
- Being tested
- Blood sample
- Keywords
- Biomarkers, Genetic, Chronic arthritis, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Conservation at the end of the blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responsive patients with a given polymorphism (%)
Measured: At the inclusion
Secondary outcomes (2)
Distribution of patients with a given biotherapy (%)
Measured: At the inclusion
Distribution of patients presenting a given polymorphism (%)
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle TOUITOU, MD, PhD, Principal investigator, Montpellier Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909998
- Sponsor's protocol ID
- 8359
- Other IDs
- 2008-A01087-48
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ladhari C, Le Blay P, Vincent T, Larbi A, Rubenstein E, Lopez RF, Jorgensen C, Pers YM. Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study. BMC Rheumatol. 2020 Feb 28;4:5. doi: 10.1186/s41927-019-0109-0. eCollection 2020.
PubMed 32161846
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Genetic Markers of Response to Biologic Therapies in Chronic Arthritis
- ClinicalTrials.gov ID
- NCT02909998
- Acronym / sponsor ID
- 8359
- Conditions
- Chronic Arthritis
- Keywords
- Biomarkers, Genetic, Chronic arthritis, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Sep 2016 (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.
Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.
Detailed description
Chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. Some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. This study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients referred for chronic arthritis
Key inclusion criteria (1 listed)
- All patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by GPs questionnaires), physical therapists visits, occupational therapists, psychologists.. etc
Key exclusion criteria (3 listed)
- Patients treated with biological therapy for non rheumatic disease
- Other inflammatory diseases such as Crohn's disease
- Refusal to participate in the collection
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 |
|---|---|---|
| Blood sampleConservation at the end of the blood sample | Other | – |
Primary outcome
Proportion of responsive patients with a given polymorphism (%)
Time frame: At the inclusion
2 secondary outcomes
Distribution of patients with a given biotherapy (%)
Time frame: At the inclusion
Distribution of patients presenting a given polymorphism (%)
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 32161846Ladhari C, Le Blay P, Vincent T, Larbi A, Rubenstein E, Lopez RF, Jorgensen C, Pers YM. Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study. BMC Rheumatol. 2020 Feb 28;4:5. doi: 10.1186/s41927-019-0109-0. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Isabelle TOUITOU, MD, PhD principal investigator
Montpellier Hospital University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Arthritis, run by University Hospital, Montpellier.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of responsive patients with a given polymorphism (%) (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909998, which also lists 1 linked publication.
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 21 Sep 2016.