polymyalgia rheumatica
Conditions
Interventions
rituximab 1*1000mg
Sponsors
None. This is an investigator initiated trial
Eligibility
Inclusion criteria
Inclusion criteria: ·PMR according to the Chuang PMR classification criteria ·Signed written informed consent
Exclusion criteria
Exclusion criteria: ·Not being able to speak, read or write Dutch ·PMR diagnosed >4 weeks before inclusion in the study ·Exposure to GC or other immunosuppressant treatments in the past 3 months more than 2 weeks and more than a week before inclusion of the study ·Known concomitant GCA or other rheumatic diseases such as RA, spondylarthropathies, connective tissue diseases, drug-induced myopathies, active and untreated thyroid disorders, Parkinson disorder or severe fibromyalgia ·Previous hypersensitivity for prednisone, RTX or murine peptides ·Contra-indications to RTX such as active current infection, including hepatitis B or tuberculosis infection, state of severe immunodeficiency, severe heart failure (NYHA-class IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To compare in both groups: -GC cumulative dose after 21 weeks; -Proportion of patients achieving a relatively safe low dose of GC (5 mg or less) after 21 weeks -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; -Change in BAFF, IL-6 -Presence of anti-ferritin antibodies and RTX antibodies; -Frequency and types of GC-related adverse events during the study by using the GTI -Frequency and types of GC- and RTX-related adverse events during the study | — |
Outcome results
None listed