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Confinement and Spondyloarthritis Treatment

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT04355923
Collaborator
(none)
1,000
Enrollment
1
Location
25
Anticipated Duration (Days)
1217.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the impact of confinement on treatment use in spondyloarthritis. Study hypothesis that with the confinement, subjects will stop their treatment. The main objective is to study the impact of confinement on treatment. And secondly to look for for specific psychological profile linked to the interruption of the treatment. the study population consists of patients with spondyloarthritis and belonging to a patient association (ACS). All patients over 18 are included. A mailing questionnaire will be send to all patients. data on diseases activity and treatment will be collected

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Confinement on the Treatment of Spondyloarthritis.
    Actual Study Start Date :
    Apr 20, 2020
    Anticipated Primary Completion Date :
    May 15, 2020
    Anticipated Study Completion Date :
    May 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. treatment use [1 month]

      treatment continuation

    Secondary Outcome Measures

    1. activity of disease [1 week]

      number of crisis

    2. psychological aspects [1 month]

      Ten Item Personality Inventory rated on a scale from 1, disagree strongly, to 7, agree strongly)

    3. psychological aspects [1 month]

      quality of life questionnaire (EQ-5D) evaluating mobility, self care, usual activity, pain and anxiety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • spondyloarthritis,

    • age over 18 ans

    • treatment by NSAID or biological treatment to be part of the patient association "ACS" (action contre les spondylarthropathies).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nice Nice France 06300

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nice

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nice
    ClinicalTrials.gov Identifier:
    NCT04355923
    Other Study ID Numbers:
    • 20rhumatocovid01
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    May 13, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis

    Study Results

    No Results Posted as of May 13, 2020