COVID-19 vaccine in patients with rheumatic diseases: The impact of treatments on the vaccine response protection against infection (COVID19-REUMA)

Phase 1

• Conditions: rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-000880-63-SE
• Lead Sponsor: Skåne University Hospital, department of rheumatology in Lud and Malmö

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 868

Inclusion Criteria

-age>18 years
-having regularly follow up at any of participating rheumatology centra
-receiving immunomodulating treatment above for at least 3 months ( only for patients)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368

Exclusion Criteria

-receiving immunomodulating treatment for other conditions than rheumatic disease
-pregnancy
-changes of immunomodulating treatment four weeks before the vaccination
-not willing to get vaccinated against COVID19
-ongoing COVID19 or other infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified