The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study.

The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study. - RTX-COVAC

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50851

Enrollment

270

Registered

2021-03-08

Start date

2021-04-12

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

rheumatism rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Humoral response (IgT against COVID-19 >= 1.1) 2-4 weeks after second vaccine dose	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results