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Research into the effect of the COVID-19 vaccines on patients with rheumatoid arthritis, treated with rituximab

Humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28096
Enrollment
270
Registered
2021-03-16
Start date
2021-03-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis (either 2010 ACR/EULAR RA criteria and/or 1987 ACR RA criteria and/or clinical diagnosis of the treating rheumatologist); Treatment with at least one dose of rituximab in the year prior to the first COVID-19 vaccine dose; Expected to receive a registered COVID-19 vaccine or has received a registered COVID-19 vaccine in the last 6 months; > 16 years old and mentally competent; Ability to read and communicate in Dutch. Amendment: Expected to receive a third registered COVID-19 vaccine or has received a third registered COVID-19 vaccine.

Exclusion criteria

Exclusion criteria: Not eligible (for example allergic to one of the vaccine ingredients) or not willing to receive the COVID-19 vaccine.

Design outcomes

Primary

MeasureTime frame
Response against COVID-19 vaccine 2-6 weeks after last vaccine dose, measured by IgT antibody index titre against COVID-19 (IgT >= 1.1) Amendment: Response against COVID-19 vaccine 2-6 weeks after third vaccine dose, dichotomized between ‘sufficient’ and ‘insufficient’ response based on the cut-off of the specific assay used.

Secondary

MeasureTime frame
Response against COVID-19 vaccine 3-6 months after last vaccine dose, measured by IgT antibody index titre against COVID-19 (IgT >= 1.1)

Contacts

Public ContactCeleste van der Togt

Sint Maartenskliniek

C.vanderTogt@maartenskliniek.nl024 3272793

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)