The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study.
Phase 4
Completed
- Conditions
- rheumatismrheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON50851
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 259
Inclusion Criteria
* Rheumatoid arthritis: either 2010 EULAR/ACR RA and/or 1987 ACR RA criteria
and/or clinical diagnosis of the treating rheumatologist;
* Treatment with at least one dose of rituximab (most of the times 200 mg, 500
mg or 1000 mg one or two times, but all dosages are included) in the year prior
to the COVID-19 vaccine;
* Expected to receive a registered COVID-19 vaccine or have received a
registered COVID-19 vaccine in the last 6 months;
* *16 years old and mentally competent;
* Ability to read and communicate in Dutch.
Exclusion Criteria
* Not eligible (for example allergic to one of vaccine ingredients) or not
willing to receive the COVID-19 vaccine;
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Humoral response (IgT against COVID-19 >= 1.1) 2-4 weeks after second vaccine<br /><br>dose</p><br>
- Secondary Outcome Measures
Name Time Method <p>Humoral response (IgT against COVID-19 >= 1.1) 2-6 months after second vaccine<br /><br>dose<br /><br>Humoral response (IgT against COVID-19 >= 1.1) 2-6 weeks after the third<br /><br>vaccine dose, in the participants with insufficient response after the 2nd<br /><br>vaccine dose.</p><br>