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Rheumatoid ArthritisNor-vaCNCT04798625

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

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Diakonhjemmet Hospital at 2 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,300 participants
Where
2 sitesNorway
Study dates
15 Feb 2021to 15 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Candidate patients will be recruited from the population treated at the two study centres and, if eligible, asked to participate in the observational cohort

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Akershus University Hospital

    Lørenskog

  • Diakonhjemmet Hospital

    Oslo

Other trials in Norway

About this study

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

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.

Read the 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, these patients may also be at risk for a less robust vaccine response. There is an urgent need to assess the humoral and cellular immune response to COVID-19 vaccines in these patient groups. The clinical consequences could be to administer several re-vaccinations or to adjust medication. This prospective, observational study aims to assess the immune response after COVID vaccination in patients suffering from inflammatory diseases and using immunosuppressive medication. Also, liver transplanted patients on immunosuppressive medication will be included.

Serum and whole blood samples will be obtained from all participants before and 1-4 weeks after the vaccination. Additionally, serum samples will be collected every 3-6 months for 5 years. If patients are allotted further vaccine doses , the patient response will be assessed by blood tests 2-4 weeks after any additional vaccine doses. In a subset of patients, samples will be drawn to study cellular immune responses. Demographic data and data regarding immunosuppressive medication will be recorded. Disease activity (clinical activity indices and biomarkers of inflammation) will be assessed. Blood samples will be obtained for biobank. Information regarding vaccination status and potential COVID-19 testing will be obtained from relevant registers.

Medical subject headings
Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylarthritis, Crohn Disease, Colitis, Ulcerative, Hepatitis, Autoimmune

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04798625
Study groupRoleWhat they receive
Rheumatoid arthritisPatients with a clinical diagnosis of rheumatoid arthritis and treated with immunosuppressive medication
Psoriatic arthritisPatients with a clinical diagnosis of psoriatic arthritis and treated with immunosuppressive medication
SpondyloarthritisPatients with a clinical diagnosis of spondyloarthritis and treated with immunosuppressive medication
Crohn diseasePatients with a clinical diagnosis of Crohn disease and treated with immunosuppressive medication
Ulcerative colitisPatients with a clinical diagnosis of ulcerative colitis and treated with immunosuppressive medication
Autoimmune hepatitisPatients with a diagnosis of autoimmune hepatitis and treated with immunosuppressive medication
Liver transplantPatients who have undergone liver transplantation and are treated with immunosuppressive drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serological response

    Change from baseline in serum levels of anti-SARS-CoV-2 antibodies

    Measured: 4 weeks after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years

Secondary outcomes (6)

  1. Cellular response

    Change from baseline in T cell reactivity to SARS-CoV-2

    Measured: 7-10 days after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years

  2. Adverse events

    Occurence of patient-reported adverse events related to vaccination against COVID-19

    Measured: Reported by patient for the first 48 hours following each vaccine dose

  3. BASDAI

    BASDAI questionnaire to assess disease activity in spondyloarthritis

    Measured: Within 4 weeks of the patient receiving the final dose of vaccine

  4. Partial Mayo score

    Partial Mayo score to assess disease activity in ulcerative colitis

    Measured: Every 3 months for the first year of study, every 6 months thereafter until study completion

  5. Harvey-Bradshaw index (HBI)

    Harvey-Bradshaw index to assess disease activity in Crohn disease

    Measured: Every 3 months for the first year of study, every 6 months thereafter until study completion

  6. DAS28

    Disease Activity Score 28 to assess disease activity in RA and PsA

    Measured: Within 4 weeks of the patient receiving the final dose of vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start15 Feb 2021
  3. Primary completion15 Feb 2026 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04798625
Sponsor's protocol ID
DIA2021-1
Acronym
Nor-vaC
Status last verified
Feb 2024
First submitted
10 Mar 2021
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jyssum I, Kared H, Tran TT, Tveter AT, Provan SA, Sexton J, Jorgensen KK, Jahnsen J, Kro GB, Warren DJ, Vaage EB, Kvien TK, Nissen-Meyer LH, Anderson AM, Grodeland G, Haavardsholm EA, Vaage JT, Mjaaland S, Syversen SW, Lund-Johansen F, Munthe LA, Goll GL. Humoral and cellular immune responses to two and three doses of SARS-CoV-2 vaccines in rituximab-treated patients with rheumatoid arthritis: a prospective, cohort study. Lancet Rheumatol. 2022 Mar;4(3):e177-e187. doi: 10.1016/S2665-9913(21)00394-5. Epub 2021 Dec 23.

    PubMed 34977602

  • Syversen SW, Jyssum I, Tveter AT, Tran TT, Sexton J, Provan SA, Mjaaland S, Warren DJ, Kvien TK, Grodeland G, Nissen-Meyer LSH, Ricanek P, Chopra A, Andersson AM, Kro GB, Jahnsen J, Munthe LA, Haavardsholm EA, Vaage JT, Lund-Johansen F, Jorgensen KK, Goll GL. Immunogenicity and Safety of Standard and Third-Dose SARS-CoV-2 Vaccination in Patients Receiving Immunosuppressive Therapy. Arthritis Rheumatol. 2022 Aug;74(8):1321-1332. doi: 10.1002/art.42153. Epub 2022 Jun 29.

    PubMed 35507355

  • Christensen IE, Jyssum I, Tveter AT, Sexton J, Tran TT, Mjaaland S, Kro GB, Kvien TK, Warren DJ, Jahnsen J, Munthe LA, Haavardsholm EA, Vaage JT, Grodeland G, Lund-Johansen F, Jorgensen KK, Syversen SW, Goll GL, Provan SA. The persistence of anti-Spike antibodies following two SARS-CoV-2 vaccine doses in patients on immunosuppressive therapy compared to healthy controls-a prospective cohort study. BMC Med. 2022 Oct 5;20(1):378. doi: 10.1186/s12916-022-02587-8.

    PubMed 36199139

  • Syversen SW, Jyssum I, Tveter AT, Sexton J, Christensen IE, Tran TT, Bjorlykke KH, Mjaaland S, Warren DJ, Kvien TK, Chopra A, Kro GB, Jahnsen J, Munthe LA, Haavardsholm EA, Grodeland G, Vaage JT, Provan SA, Jorgensen KK, Goll GL. Immunogenicity and safety of a three-dose SARS-CoV-2 vaccination strategy in patients with immune-mediated inflammatory diseases on immunosuppressive therapy. RMD Open. 2022 Nov;8(2):e002417. doi: 10.1136/rmdopen-2022-002417.

    PubMed 36328399

  • Bjorlykke KH, Orbo HS, Tveter AT, Jyssum I, Sexton J, Tran TT, Christensen IE, Kro GB, Kvien TK, Jahnsen J, Munthe LA, Chopra A, Warren DJ, Mjaaland S, Haavardsholm EA, Grodeland G, Provan SA, Vaage JT, Syversen SW, Goll GL, Jorgensen KK. Four SARS-CoV-2 vaccine doses or hybrid immunity in patients on immunosuppressive therapies: a Norwegian cohort study. Lancet Rheumatol. 2023 Jan;5(1):e36-e46. doi: 10.1016/S2665-9913(22)00330-7. Epub 2022 Nov 16.

    PubMed 36415604

  • Jorgensen KK, Hoivik ML, Chopra A, Benth JS, Ricanek P, Moum PB, Jyssum I, Bolstad N, Warren DJ, Vaage PJT, Munthe PLA, Lundin PKEA, Anisdahl K, Syversen SW, Goll GL, Lund-Johansen F, Medhus AW, Jahnsen PJ. Humoral immune response to SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive medication: association to serum drug levels and disease type. Scand J Gastroenterol. 2023 Jul-Dec;58(8):874-882. doi: 10.1080/00365521.2023.2177884. Epub 2023 Feb 14.

    PubMed 36788656

  • Orbo HS, Bjorlykke KH, Sexton J, Jyssum I, Tveter AT, Christensen IE, Mjaaland S, Kvien TK, Grodeland G, Kro GB, Jahnsen J, Haavardsholm EA, Munthe LA, Provan SA, Vaage JT, Goll GL, Jorgensen KK, Syversen SW. Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy: identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study. RMD Open. 2024 Apr 9;10(2):e003545. doi: 10.1136/rmdopen-2023-003545.

    PubMed 38599653

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Diakonhjemmet Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serological response (time frame: 4 weeks after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798625, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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Nor-vaC Clinical Trial NCT04798625 | AzTrials