REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica
- Conditions
- Polymyalgia rheumaticaMedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2022-003127-18-NL
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 114
•Newly diagnosed PMR (<12 weeks) according to the 2012 EULAR/ACR classification criteria.
•Glucocorticoid treatment = 8 weeks
•Glucocorticoid dose equivalent of prednisolone =30 mg/day.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114
•Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) =3 months prior to inclusion
•(clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory disease
•Concomitant conditions that might significantly interfere with evaluation of PMR pain or movement as judged by the investigator
•Previous hypersensitivity for RTX of contra-indications to RTX
•Not being able to speak, read or write Dutch
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method