Polymyalgia Rheumatica
Conditions
Brief summary
Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.
Interventions
DRUGRituximab
Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication
DRUGPlacebo
Placebo in 250ml NaCl 0.9% intravenously with usual premedication
Sponsors
Sint Maartenskliniek
Dutch Arthritis Association
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Polymyalgia rheumatica diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria * Diagnoses less than 12 weeks ago * Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day * Informed consent
Exclusion criteria
* treatment with systemic immunosuppressants (other than glucocorticoids) 3 months prior to inclusion; * (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases; * concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator; * previous hypersensitivity for RTX or contra-indications to RTX.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between group difference in percentage of patients in glucocorticoid-free remission | At week 52 | Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score \< 10) at week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients in glucocorticoid-free remission | 21 weeks | Percentage of patients in glucocorticoid-free remission |
| Percentage of patients with glucocorticoid dose of ≤5mg/day | 52 weeks | Percentage of patients with glucocorticoid dose of ≤5mg/day |
| Number of relapses | 52 weeks | Number of relapses |
| Time to glucocorticoid-free remission | 52 weeks | Time to glucocorticoid-free remission in days during the study period |
| Time to relapse | 52 weeks | Time to relapse in days during the study period |
| Cumulative glucocorticoid dose | 52 weeks | Cumulative glucocorticoid dose |
| Percentage of patients needing RTX/Placebo retreatment | 52 weeks | Percentage of patients needing RTX/Placebo retreatment |
| Adverse events | 52 weeks | Adverse events |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORAatke van der Maas, MD PhD
Sint Maartenskliniek
Outcome results
None listed