Juvenile Idiopathic ArthritisRHUMAJICOVIDNCT04407923
Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment
An observational study of Juvenile Idiopathic Arthritis and COVID 19, run by University Hospital, Brest at 8 sites in France.
Trial summary
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, COVID 19, Treatment
- How many people
- 150 participants
- Where
- 8 sitesFrance
- Study dates
- 25 May 2020to 25 Nov 2020
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Juvenile Idiopathic Arthritis patients with ongoing DMARD therapy.
Who may be able to join
- Juvenile Idiopathic Arthritis satisfying Edmonton criteria
- Ongoing DMARD therapy or AINS for 3 months
Who cannot join
- Inhability to consent
Trial locations and contacts
8 sites in 1 country.
Valerie DEVAUCHELLE contact
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CH de Belfort
Belfort, 90015
Anne Lohse
- Not yet recruiting
CHU de Bordeaux
Bordeaux, 33000
Pascal Pillet
- Recruiting
CHRU de Brest
Brest, 29609
Valerie Devauchelle-Pensec, valerie.devauchelle-pensec@chu-brest.fr
- Not yet recruiting
AP-HP Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94275
Linda Rossi
- Not yet recruiting
CHU de Poitiers
Poitiers, 86021
Elisabeth Gervais
- Not yet recruiting
CHU de Rennes
Rennes, 35000
Véronique Despert
- Not yet recruiting
CHU de Strasbourg
Strasbourg, 67200
Christelle Sordet
- Not yet recruiting
CHU de Nancy
Vandœuvre-lès-Nancy, 54711
Irène Lemelle
About this study
Official title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.
- Conditions
- Juvenile Idiopathic Arthritis, COVID 19, Treatment
- Medical subject headings
- Arthritis, Juvenile, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis
Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start25 May 2020
- Primary completion25 Nov 2020 (estimated)
- Study completion25 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407923
- Sponsor's protocol ID
- RHUMAJICOVID (29BRC20.0148)
- Acronym
- RHUMAJICOVID
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context
- ClinicalTrials.gov ID
- NCT04407923
- Acronym / sponsor ID
- RHUMAJICOVID / RHUMAJICOVID (29BRC20.0148)
- Conditions
- Juvenile Idiopathic Arthritis, COVID 19, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 Nov 2020 (estimated)
- Study completion
- 25 Nov 2020 (estimated)
- First posted
- 29 May 2020 (actual)
- 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 current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Juvenile Idiopathic Arthritis patients with ongoing DMARD therapy.
Key inclusion criteria (2 listed)
- Juvenile Idiopathic Arthritis satisfying Edmonton criteria
- Ongoing DMARD therapy or AINS for 3 months
Key exclusion criteria (1 listed)
- Inhability to consent
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
Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis
Time frame: 1 Day
Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Yes
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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.
Valerie DEVAUCHELLE contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and COVID 19, run by University Hospital, Brest at 8 sites in France.
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 2 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: status not confirmed, as of the sponsor's last update on 29 May 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie DEVAUCHELLE (02 98 34 72 64, valerie.devauchelle-pensec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis (time frame: 1 Day). 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 29 May 2020.