To investigate, in RA patients, the role of different RTX doses (200, 500 and 1000mg) and timing of RTX on risk of obtaining adequate humeral response against COVID-19 vaccines, by performing a sensitivity analysis on response, using logistic…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Humoral response (IgT against COVID-19 >= 1.1) 2-4 weeks after second vaccine
dose
Secondary outcome
Humoral response (IgT against COVID-19 >= 1.1) 2-6 months after second vaccine
dose
Humoral response (IgT against COVID-19 >= 1.1) 2-6 weeks after the third
vaccine dose, in the participants with insufficient response after the 2nd
vaccine dose.
Background summary
Many vaccines are being deployed to prevent corona virus disease 2019
(COVID-19) infections. Although these vaccines appear to be safe and effective
in the general population less is known about the effectiveness of these
vaccines in patients with rheumatoid arthritis treated with rituximab.
Previous studies showed decreased vaccination response to influenza and
pneumococcal vaccinations in RA patients. However, all these studies have been
performed with registered high dose RTX (2x 1000 mg), whereas optimal efficacy
in RA can be reached with low-dose (1x 1000 mg) or ultra-low dose (1x 500 mg or
1x 200 mg) RTX.
Therefore, we want to investigate the response to the COVID-19 vaccination in
patients with RA treated with different doses of RTX (200, 500 and 1000mg), and
the relation to the time between previous RTX administration and vaccination.
Study objective
To investigate, in RA patients, the role of different RTX doses (200, 500 and
1000mg) and timing of RTX on risk of obtaining adequate humeral response
against COVID-19 vaccines, by performing a sensitivity analysis on response,
using logistic regression.
Study design: Prospective (usual care) cohort study.
Study design
Patients will be requested to provide informed consent prior to the first study
visit. Blood will be drawn (6 mL EDTA tube ) at 2 or 3 points in time: 2-4
weeks after the last dose of the COVID-19 vaccination and at their next RTX
administration. A third blood sample wil be drawn in the participants with
insufficient antibody response, to measure response 2-6 weeks after the third
vaccine. Serum IgG against COVID-19 will be measured in batch process at the
end of the study. Patient, disease and treatment characteristics will be
obtained via electronic patient files. Vaccination details will be obtained via
patients* vaccination passport or their general practitioner.
Study burden and risks
The burden and risks of the study are very small for the participant, since
this study only includes two visits to draw an extra vial of blood (6 mL), of
which one is embedded in regular care and the other can be performed at home. A
potential benefit for the participant is that they can be informed about their
anti-COVID-19 antibody level at the end of the study.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000710-42-NL |
| CCMO | NL76709.091.21 |