Comparison of subcutaneous and intravenous retreatment with ultra-low dose rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial
Phase 4
Recruiting
- Conditions
- arthritisrheumatic diseasesrheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON52719
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
- Rheumatoid arthritis: either 2010 EULAR/ACR RA17 and/or 1987 ACR RA18
criteria and/or clinical diagnosis of the treating rheumatologist;
- 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;
- 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;
- >=16 years old and mentally competent;
- Ability to read and communicate well in Dutch.
Exclusion Criteria
- Previous non-response to ultra-low dose rituximab (DAS28-CRP > 2.9);
- Objection or contraindication to either of the treatment options.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method