Status:
ACTIVE_NOT_RECRUITING
Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication
Lead Sponsor:
Diakonhjemmet Hospital
Collaborating Sponsors:
University Hospital, Akershus
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the strength and duration of the immunological response to COVID-19 vaccines in patients treated with immunosuppressive and/or immunomodulating medication for im...
Detailed Description
Patients on long-term immunosuppressive and/or immunomodulating medication may be susceptible to serious COVID-19. Hence, it is important they get sufficient protection by a COVID-19 vaccine. However,...
Eligibility Criteria
Inclusion
- An established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA), ulcerative colitis (UC,) Crohns disease (CD), autoimmune hepatitis (AIH) or patients who have undergone a liver transplantation
- Treatment with relevant immunosuppressive and/or immunomodulating medication \*
- Adult patients (\> 18 years)
- Patient intends to obtain vaccination against COVID-19 during the next 6 months
- \* The following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: Rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone
Exclusion
- 1\) Allergy or intolerance to elements of the COVID-19 vaccines
- \-
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2027
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT04798625
Start Date
February 15 2021
End Date
February 15 2027
Last Update
February 23 2024
Active Locations (2)
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1
Akershus University Hospital
Lørenskog, Norway
2
Diakonhjemmet Hospital
Oslo, Norway