Arthritis, Juvenile RheumatoidJIR-cohorteNCT02377245
Juvenile Inflammatory Rheumatism (JIR) Cohorte
An observational study of Arthritis, Juvenile Rheumatoid, run by Michaël Hofer at 45 sites in 5 countries.
Trial summary
The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- How many people
- 15,000 participants
- Where
- 45 sitesin 5 countries
- Study dates
- Jan 2014to Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with juvenile inflammatory diseases
Who may be able to join
- Patients with juvenile inflammatory diseases
- Age at onset up to 18 years old
- Consent according national codes of ethics and current laws
Who cannot join
- Non-consent from patients and/or legal representative
Trial locations and contacts
45 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 5 countries
France25 sites
CHU Belfort
Belfort
CHRU Besançon
Besançon
Hôpital Pellegrin enfants
Bordeaux, 33000
CHRU Brest
Brest
Hôpital Femme Mère Enfant
Bron, 69677
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CHU de Grenoble
Grenoble
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU Lille
Lille
Hôpital Nord Marseille
Marseille
CHU Arnaud de Villeneuve
Montpellier, 34295
Centre hospitalier de Mulhouse
Mulhouse, 68100
CHU Nantes
Nantes
Nice CHU - Lenval
Nice
CHU Nimes
Nîmes
Hôpital necker Enfants Malade
Paris
Hôpital Robert Debré
Paris
Hôpital Tenon
Paris
CHU Reims
Reims
CHU Rennes
Rennes
CHU St-Etienne
Saint-Etienne
Hôpital de Hautepierre
Strasbourg, 67100
Hôpital des enfants
Toulouse, 31059
CHU Tours
Tours
Hôpital André Mignot
Versailles, 78157
Switzerland13 sites
Kantonsspital Aarau
Aarau, 5000
Kinderspital Basel
Basel, 4056
Universitäts-Augenklinik Basel
Basel
Ospedale Regionale di Bellinzona e valli
Bellinzona
Kantonspital Graubunden
Chur, 7000
CHUV
Lausanne, Canton of Vaud, 1011
Hôpital Ophtalmique
Lausanne, 1004
Kinderspital Luzern
Lucerne, 6000
Ospedale Regionale di Lugano
Lugano
Ostschweizer Kinderspital St-Gallen
Sankt Gallen
Klinik für Rheumatologie und internistische Rehabilitation
Valens, 7317
Kantonspital Winterthur
Winterthur
Kinderspital Zürich
Zurich, 8032
Belgium5 sites
Hôpital Reine Fabiola
Brussels
CHU Charleroi
Charleroi
UZ Leuven
Leuven, 3000
CHC Liège
Liège
CHR Citadelle
Liège
About this study
Official title: Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases
The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.
Read the detailed description
The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year.
Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Juvenile, Inflammatory, Rheumatism, Pediatric-Onset inflammatory diseases
- Medical subject headings
- Arthritis, Juvenile, Rheumatic Diseases
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 |
|---|---|---|
| Juvenile Inflammatory Rheumatism | Juvenile Inflammatory Rheumatism patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe and very severe adverse event as a mesure of safety and tolerability
Measured: 10 years
Number of treatments prescribed off label
Measured: 10 Years
Length in months of drug survival in patient treated with at least two consecutive biological agents
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
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 Arthritis, Juvenile RheumatoidStudies 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
- 15,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Michaël Hofer
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, Versailles Hospital, Tenon Hospital, Paris, Bicetre Hospital, University of Lausanne Hospitals, University Hospital Muenster, Fondation Rhumatismes-Enfants-Suisse
- Responsible party
- Sponsor-investigator, Michaël Hofer, University of Lausanne Hospitals
- Investigators
- Michael Hofer, Study director, University of Lausanne HospitalsVéronique Hentgen, Study director, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377245
- Sponsor's protocol ID
- JIR-001
- Acronym
- JIR-cohorte
- Status last verified
- Jun 2023
- First submitted
- 9 Oct 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pouletty M, Borocco C, Ouldali N, Caseris M, Basmaci R, Lachaume N, Bensaid P, Pichard S, Kouider H, Morelle G, Craiu I, Pondarre C, Deho A, Maroni A, Oualha M, Amoura Z, Haroche J, Chommeloux J, Bajolle F, Beyler C, Bonacorsi S, Carcelain G, Kone-Paut I, Bader-Meunier B, Faye A, Meinzer U, Galeotti C, Melki I. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 mimicking Kawasaki disease (Kawa-COVID-19): a multicentre cohort. Ann Rheum Dis. 2020 Aug;79(8):999-1006. doi: 10.1136/annrheumdis-2020-217960. Epub 2020 Jun 11.
PubMed 32527868
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT02377245
- Acronym / sponsor ID
- JIR-cohorte / JIR-001
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Juvenile, Inflammatory, Rheumatism, Pediatric-Onset inflammatory diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Michaël HoferUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, Versailles Hospital, Tenon Hospital, Paris, Bicetre Hospital, University of Lausanne Hospitals, University Hospital Muenster, Fondation Rhumatismes-Enfants-Suisse
- Study start
- Jan 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Mar 2015 (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.
The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.
Detailed description
The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year.
Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvenile Inflammatory Rheumatism | – | –Juvenile Inflammatory Rheumatism patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with juvenile inflammatory diseases
Key inclusion criteria (3 listed)
- Patients with juvenile inflammatory diseases
- Age at onset up to 18 years old
- Consent according national codes of ethics and current laws
Key exclusion criteria (1 listed)
- Non-consent from patients and/or legal representative
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
Number of severe and very severe adverse event as a mesure of safety and tolerability
Time frame: 10 years
Number of treatments prescribed off label
Time frame: 10 Years
Length in months of drug survival in patient treated with at least two consecutive biological agents
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 32527868Pouletty M, Borocco C, Ouldali N, Caseris M, Basmaci R, Lachaume N, Bensaid P, Pichard S, Kouider H, Morelle G, Craiu I, Pondarre C, Deho A, Maroni A, Oualha M, Amoura Z, Haroche J, Chommeloux J, Bajolle F, Beyler C, Bonacorsi S, Carcelain G, Kone-Paut I, Bader-Meunier B, Faye A, Meinzer U, Galeotti C, Melki I. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 mimicking Kawasaki disease (Kawa-COVID-19): a multicentre cohort. Ann Rheum Dis. 2020 Aug;79(8):999-1006. doi: 10.1136/annrheumdis-2020-217960. Epub 2020 Jun 11.
- Official jir-cohorte project webpageLink provided by the sponsor.
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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.
Michael Hofer study director
University of Lausanne Hospitals
Véronique Hentgen study director
Versailles Hospital
45 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Juvenile Rheumatoid, run by Michaël Hofer at 45 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in France, Switzerland, Belgium, Germany, Morocco. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of severe and very severe adverse event as a mesure of safety and tolerability (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT02377245, 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 15 Jun 2023.