Research into the effect of the COVID-19 vaccines on patients with rheumatoid arthritis, treated with rituximab
- Conditions
- Rheumatoid arthritis
- Registration Number
- NL-OMON28096
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
van der Togt CJT, Ten Cate DF, den Broeder N, Rahamat-Langendoen J, van den Bemt BJF, den Broeder AA. Humoral response to Coronavirus Disease-19 vaccines is dependent on dosage and timing of rituximab in patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 4:keac206. doi: 10.1093/rheumatology/keac206.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
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.
Not eligible (for example allergic to one of the vaccine ingredients) or not willing to receive the COVID-19 vaccine.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response against COVID-19 vaccine 2-6 weeks after last vaccine dose, measured by IgT antibody index titre against COVID-19 (IgT >= 1.1)<br><br>Amendment:<br>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 Outcome Measures
Name Time Method Response against COVID-19 vaccine 3-6 months after last vaccine dose, measured by IgT antibody index titre against COVID-19 (IgT >= 1.1)