EUCTR2020-002507-19-NL
Active, not recruiting
Phase 1
Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- rheumatoid arthritis
- Sponsor
- Sint Maartenskliniek
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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;
Outcomes
Primary Outcomes
Not specified
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