rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis
Conditions
Interventions
Trade Name: Comirnaty
Product Name: Comirnaty
Pharmaceutical Form: Injection
INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)
Current Sponsor code: 005735
Other descriptive name: COVI
Sponsors
Skåne University Hospital, department of rheumatology in Lud and Malmö
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aims of the present study are to elucidate the antibody- and T cells response, long-term immunogenicity and protection against infection following vaccination with a non-live COVID19 vaccine in patients with IRD treated with immunomodulating drugs compared to healthy controls. More spceificaly the objective is to study if any of immunomodulating (biologic) treatment given in monotherapy or in combination with synthetic disease modifying anti-rheumatic drugs (DMARDs) impair antibody response to a COVID19 vaccine in patients with IRD compared to controls without IRD or immunosuppressive treatment for other diseases?;Secondary Objective: Seconday objectives are to elucidate if : vaccination against COVID19 is well tolerated in these patients or is vaccination associated with increased risk of flare in the underlying rheumatic disease or an onset of any other auto-immune disease immunomodulating treatments for IRD have an impact on the long-term immunogenicity of the COVID19 vaccine vaccination decreases the occurrence of COVID19 infections following vaccination in these patients compared to age- gender- and geographic are matched Controls ;Primary end point(s): The percentage of individuals in each treatment group reaching seroconversion i.e. 4-fold increase in anti-spike IgG and controls 2-6 weeks following vaccination, ;Timepoint(s) of evaluation of this end point: 2-4 weeks after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes 1)The percentage of individuals in each treatment with not decreasing IgG anti-spike antibody levels after 6-7 months and 9-12 months following vaccination compared to controls 2) Percentage of patients with IRD reporting increased activity in the underlying rheumatic diseases and % patients reporting the onset of any other auto-immune disease compared to controls 3) Number of vaccinated patients diagnosed with COVID19 infections within a year following vaccination compared to Controls ;Timepoint(s) of evaluation of this end point: 6-7 motnhs and 9-12 months after vaccination | — |
Countries
Sweden
Contacts
Public ContactDept of rheumatology Lund/Malmö
Skåne University Hospital, department of rheeumatology
Outcome results
None listed