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NCT04407923 Clinical Trial

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

Juvenile Idiopathic Arthritis Clinical Trial

— RHUMAJICOVID  

Official title:
Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04407923
Other study ID # RHUMAJICOVID (29BRC20.0148)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date November 25, 2020

Study information
Verified date May 2020
Source University Hospital, Brest
Contact Valerie DEVAUCHELLE
Phone 02 98 34 72 64
Email valerie.devauchelle-pensec@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date November 25, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Juvenile Idiopathic Arthritis satisfying Edmonton criteria

- Ongoing DMARD therapy or AINS for 3 months

Exclusion Criteria:

- Inhability to consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CH de Belfort Belfort
France CHU de Bordeaux Bordeaux
France CHRU de Brest Brest
France AP-HP Hôpital Kremlin-Bicêtre Le Kremlin-Bicêtre
France CHU de Poitiers Poitiers
France CHU de Rennes Rennes
France CHU de Strasbourg Strasbourg
France CHU de Nancy Vandœuvre les Nancy

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 Day
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