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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| Diakonhjemmet Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.