Research into the effects of lower doses rituximab in patients with rheumatoid arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NL-OMON23732
- Lead Sponsor
- The Sint Maartenskliniek
- Brief Summary
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30066-9/fulltext
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
•Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion.
•RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included.
Exclusion Criteria
•Patients with known (non-)response to ultra-low dose RTX (below 1 × 1000 mg)
•Current corticosteroid dosing above 10 mg per day prednisolone equivalent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •DAS28-CRP at 3 and 6 months<br><br /><br /><br>The primary endpoints will be tested using 95% confidence intervals based on linear regression with the change in DAS28-CRP as outcome, dose group as determinant, and baseline values of DAS28-CRP as covariate (ANCOVA). A non-inferiority margin of 0.6 will be used. <br /><br>Multiplicity over the primary endpoints will be protected by a fixed testing procedure as follows. First the non-inferiority of the 500mg vs 1000mg at 3 months will be tested at p<0.05 (two-sided). If this is statistically significant, then 500mg vs 1000mg will be tested at p<0.05 (two-sided) at 6 months. If that is successful, then 200mg vs 1000mg will be tested at p<0.05 (two-sided) at 3 months and if that is statistically significant, the last test will be 200mg vs 1000mg at p<0.05 (two-sided) at 6 months.<br>
- Secondary Outcome Measures
Name Time Method •Other measures for disease activity (VAS-pain, VAS-global care provider, OMERACT flare questionnaire)<br /><br>•Function (HAQ-DI)<br /><br>•Quality of life (EQ5D-5L)<br /><br>•Adverse events<br /><br>•Medication use<br /><br>•Costs<br /><br>