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

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-000710-42-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-08
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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; <br>To analyse the independent effect of various demographics, disease characteristics and comedication on the primary objective and on the humoral immunogenicity itself. <br>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 Outcome Measures

Name	Time	Method
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