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

Sponsor
University Hospital, Brest (Other)
Overall Status
Unknown status
CT.gov ID
NCT04393233
Collaborator
(none)
300
Enrollment
1
Location
30
Anticipated Duration (Days)
304.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Apr 23, 2020
    Anticipated Primary Completion Date :
    May 23, 2020
    Anticipated Study Completion Date :
    May 23, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis [1 Day]

      Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Rheumatoid arthritis satisfying ACR/EULAR criteria

    • Ongoing DMARD therapy

    Exclusion Criteria:
    • Inhability to consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04393233
    Other Study ID Numbers:
    • RHUMACOVID ( 29BRC20.0110)
    First Posted:
    May 19, 2020
    Last Update Posted:
    May 29, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of May 29, 2020