Research into administration of lower dosed rituximab using an injection in patients with Rheumatoid Arthritis
- Conditions
- Rheumatoid arthritis
- Registration Number
- NL-OMON20186
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
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.
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg, with the lower boundary of the 95% confidence interval of AUC0-6mnd,SC : AUC0-6mnd,IV exceeding the non-inferiority margin of 0.8.
- Secondary Outcome Measures
Name Time Method •To describe the relevant pharmacokinetic parameters of rituximab 336 mg SC compared to 200 mg IV: peak level, trough level, Cavg;<br>•To evaluate the between group difference in changes in disease activity (DAS28-CRP) after 6 months, compared to a NI margin of 0.6;<br>•To evaluate the between group differences on B-cell counts;<br>•To assess the differences in incidence of anti-drug antibodies (ADAs);<br>•To assess the incidence of AEs in both groups; <br>•To assess patient preferences for either SC or IV formulation.