The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica
- Conditions
- 10003816polymyalgiapolymyalgia rheumatica
- Registration Number
- NL-OMON45885
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
·PMR according to the ACR/EULAR 2012 PMR core classification criteria;·Signed written informed consent
·Not being able to speak, read or write Dutch
·Polymyalgia rheumatica diagnosed more than 4 weeks before inclusion in the study
·Exposure to Glucocorticoids or other immunosuppressant treatments in the past 3 months
·Known concomitant giant cell arteritis or other rheumatic diseases such as rheumatoid arthritis, spondylarthropathies, connective tissue diseases, drug-induced myopathies, active and untreated thyroid disorders, Parkinson disorder or fibromyalgia
·Previous hypersensitivity for prednisone, rituximab or murine peptides
·Contra-indications to rituximab such as active current infection, including hepatitis B or tuberculosis infection, state of severe immunodeficiency, severe heart failure (NYHA-class IV)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the efficacy of RTX 1*1000 mg in newly diagnosed PMR patients<br /><br>fulfilling the ACR-criteria by determining the proportion of patients in<br /><br>complete GC-free remission at week 20; </p><br>
- Secondary Outcome Measures
Name Time Method