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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04723407
Other study ID # 87RI20_0062 /RICOVID19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date March 1, 2022

Study information

Verified date January 2021
Source University Hospital, Limoges
Contact Philippe BERTIN, MD
Phone 0555056871
Email philippe.bertin@chu-limoges.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations. They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19. The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 950
Est. completion date March 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges. Exclusion Criteria: Patients who object to the use of their data.

Study Design


Intervention

Other:
questionnaires
Questionnaire completion

Locations

Country Name City State
France Département de Rhumatologie Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary post-traumatic stress Presence or absence of post-traumatic stress disorder due to the COVID19 pandemic assessed by the Post-traumatic stress disorder Check-list version DSM-5 (PCL-5) Day 1
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