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Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment (RHUMAJICOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407923
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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 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.

Condition or disease
Juvenile Idiopathic Arthritis COVID 19 Treatment

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : November 25, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Juvenile Idiopathic Arthritis patients with ongoing DMARD therapy.
Criteria

Inclusion Criteria:

  • Juvenile Idiopathic Arthritis satisfying Edmonton criteria
  • Ongoing DMARD therapy or AINS for 3 months

Exclusion Criteria:

  • Inhability to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407923


Contacts
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Contact: Valerie DEVAUCHELLE 02 98 34 72 64 valerie.devauchelle-pensec@chu-brest.fr
Contact: Valerie DEVAUCHELLE valerie.devauchelle-pensec@chu-brest.fr

Locations
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France
CH de Belfort Not yet recruiting
Belfort, France, 90015
Contact: Anne Lohse         
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Pascal Pillet         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Valerie Devauchelle-Pensec       valerie.devauchelle-pensec@chu-brest.fr   
AP-HP Hôpital Kremlin-Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Linda Rossi         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Elisabeth Gervais         
CHU de Rennes Not yet recruiting
Rennes, France, 35000
Contact: Véronique Despert         
CHU de Strasbourg Not yet recruiting
Strasbourg, France, 67200
Contact: Christelle Sordet         
CHU de Nancy Not yet recruiting
Vandœuvre les Nancy, France, 54711
Contact: Irène Lemelle         
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04407923    
Other Study ID Numbers: RHUMAJICOVID (29BRC20.0148)
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning six months and ending five years following the end study
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases