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Clinical Trials/NL-OMON20186
NL-OMON20186
Not yet recruiting
Not Applicable

Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial

Sint Maartenskliniek0 sites36 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid arthritis
Sponsor
Sint Maartenskliniek
Enrollment
36
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all of the following 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

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Previous non\-response to ultra\-low dose rituximab (DAS28\-CRP \> 2\.9\);
  • Objection or contraindication to either of the treatment options;

Outcomes

Primary Outcomes

Not specified

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