REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 19.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002908-15-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

- Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion.

- RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included.

- At least 6 months of stable, low disease activity after the last RTX infusion (operationalized by either DAS28-CRP<2.9 (DAS28-BSE <3.2) or judgement of low disease activity by a rheumatologist) AND a current DAS28-CRP =3.5.

- Patient informed consent, =18 years old and mentally competent

- Ability to measure the outcome of the study in this patient (e.g. life expectancy > 6 months, no planned relocation out of reach of study centre)

- 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Patients with known (non-)response to ultra-low dose RTX (below 1 × 1000 mg)

- Current corticosteroid dosing above 10 mg per day prednisolone equivalent

Study & Design

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