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Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation (RHUMACOVID)

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: NCT04393233
Recruitment Status : Recruiting
First Posted : May 19, 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. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.

Condition or disease
Rheumatoid Arthritis COVID

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : May 23, 2020
Estimated Study Completion Date : May 23, 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis patients with ongoing DMARD therapy.
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis satisfying ACR/EULAR criteria
  • Ongoing DMARD therapy

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): NCT04393233


Contacts
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Contact: Dewi GUELLEC +33298347264 dewi.guelle@chu-brest.fr
Contact: Valerie Devauchelle +33298347264 valerie.devauchelle-pensec@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Dewi Guellec         
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04393233    
Other Study ID Numbers: RHUMACOVID ( 29BRC20.0110)
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning one month 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, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases