Study on the efficacy of rituximab in patients with polymyalgia rheumatica
- Conditions
- polymyalgia rheumatica
- Registration Number
- NL-OMON27507
- Lead Sponsor
- one. This is an investigator initiated trial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
·PMR according to the Chuang PMR classification criteria
·Signed written informed consent
Exclusion Criteria
·Not being able to speak, read or write Dutch
·PMR diagnosed >4 weeks before inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A preliminary estimate of the GC-sparing effect of RTX by comparing the proportion of PMR patients with GC-free remission ( PMR-AS <7 as described in section 3.1.1) in both groups
- Secondary Outcome Measures
Name Time Method To compare in both groups:<br /><br>-GC cumulative dose after 21 weeks;<br /><br>-Proportion of patients achieving a relatively safe low dose of GC (5 mg or less) after 21 weeks<br /><br>-Change in ESR and CRP, PMR-AS, inner core domain set as proposed by the OMERACT, SF-36, EQ5D-5L, HAQ-DI from baseline to 21 weeks;<br /><br>-Change in BAFF, IL-6<br /><br>-Presence of anti-ferritin antibodies and RTX antibodies;<br /><br>-Frequency and types of GC-related adverse events during the study by using the GTI<br /><br>-Frequency and types of GC- and RTX-related adverse events during the study<br><br>