Research into administration of lower dosed rituximab with an injectio

Phase 1

• Conditions: rheumatoid arthritis; MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-002507-19-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Rheumatoid arthritis: either 2010 EULAR/ACR RA and/or 1987 ACR RA criteria and/or clinical diagnosis of the treating rheumatologist;
2. Patients using rituximab in ultra-low dose: either 200 mg or 500 mg as previous dose, given every 6 months, with or without concomitant methotrexate;
3. Having sufficient response to rituximab treatment, operationalized as a DAS28-CRP < 2.9 3-6 months after the last infusion and/or judgment of low disease activity by the treating rheumatologist;
4. =16 years old and mentally competent;
5. Ability to read and communicate well 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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous non-response to ultra-low dose rituximab (DAS28-CRP > 2.9);
2. Objection or contraindication to either of the treatment options;

Study & Design

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