Research into the effect of the COVID-vaccine in patients who are treated with rituximab (RTX-COVAC 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

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000710-42-NL

Enrollment

270

Registered

2021-03-08

Start date

2021-03-15

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Rheumatoid arthritis MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Concentrate for solution for injection Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Dispersion for injec

Eligibility

Sex/Gender

All

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

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
Main Objective: To investigate, in RA patients, the role of RTX dose and timing of the vaccination related to RTX administration on the humoral immunogenicity against COVID-19 vaccines, with response/non response against the vaccine as a dichotomous outcome measure.;Secondary Objective: To perform a sensitivity analysis on the primary objective, using the antibody index number as continuous outcome measure; To analyse the independent effect of various demographics, disease characteristics and comedication on the primary objective and on the humoral immunogenicity itself. To investigate the humoral response over a longer period of time (2 weeks – 6 months) in patients with RA treated with RTX.;Primary end point(s): Total immunoglobulin (IgT) titre against COVID-19;Timepoint(s) of evaluation of this end point: 2-4 weeks after last vaccine dose	—

Measure

Time frame

Main Objective: To investigate, in RA patients, the role of RTX dose and timing of the vaccination related to RTX administration on the humoral immunogenicity against COVID-19 vaccines, with response/non response against the vaccine as a dichotomous outcome measure.;Secondary Objective: To perform a sensitivity analysis on the primary objective, using the antibody index number as continuous outcome measure; To analyse the independent effect of various demographics, disease characteristics and comedication on the primary objective and on the humoral immunogenicity itself. To investigate the humoral response over a longer period of time (2 weeks – 6 months) in patients with RA treated with RTX.;Primary end point(s): Total immunoglobulin (IgT) titre against COVID-19;Timepoint(s) of evaluation of this end point: 2-4 weeks after last vaccine dose

—

Secondary

Measure	Time frame
Secondary end point(s): Total immunoglobulin (IgT) titre against COVID-19;Timepoint(s) of evaluation of this end point: 2-6 months after last vaccine dose	—

Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

Sint Maartenskliniek

d.tencate@maartenskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026