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NCT04798625Active, not recruiting

Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication

A Norwegian Study of Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication Within Rheumatology and Gastroenterology: the Nor-vaC Study

Source: ClinicalTrials.gov · Last updated 23 Feb 2024

Brief summary (registry, in English)

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 immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2300 (actual)
First submitted
10 Mar 2021
Start date
15 Feb 2021
Primary completion date
15 Feb 2026
Lead sponsor
Diakonhjemmet Hospital
NCT number
NCT04798625

What you commit to

  • Study type: Observational
  • Participants enrolled: 2300
  • From 15 Feb 2021 to the primary completion date, 15 Feb 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 1\) Allergy or intolerance to elements of the COVID-19 vaccines

Other

  • \-

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akershus University Hospital
Coordinator of this site? Confirm its status
LørenskogNorwayUnknown status
Diakonhjemmet Hospital
Coordinator of this site? Confirm its status
OsloNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.