Skip to main content
Clinical Trials/EUCTR2020-002507-19-NL
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

Sint Maartenskliniek0 sites36 target enrollmentSeptember 3, 2020

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.

Registry
who.int
Start Date
September 3, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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

Similar Trials