Clinical trial NCT05533164: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Official title: Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Polymyalgia Rheumatica
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch Arthritis Association
First posted: 2022-09-08
Enrollment: 174
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.


Eligibility criteria: Inclusion Criteria:

* Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
* Experiencing a PMR relapse, defined as recurring of symptoms and increase in erythrocyte sedimentation rate (ESR)/ C reactive protein (CRP)
* Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent
* Informed consent

Exclusion Criteria:

* 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 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.

Primary outcomes:
measure: Between group difference in percentage of patients in glucocorticoid-free remission
timeFrame: At week 52
Secondary outcomes:
measure: Percentage of patients in glucocorticoid-free remission
timeFrame: 21 weeks
measure: Percentage of patients with glucocorticoid dose of ≤5mg/day
timeFrame: 52 weeks
measure: Number of relapses
timeFrame: 52 weeks
measure: Time to glucocorticoid-free remission
timeFrame: 52 weeks
measure: Time to relapse
timeFrame: 52 weeks
measure: Cumulative glucocorticoid dose
timeFrame: 52 weeks
measure: Percentage of patients needing RTX/Placebo retreatment
timeFrame: 52 weeks
measure: Adverse events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartensklineik
state: Gelderland
Study officials:
affiliation: Sint Maartenskliniek
name: Aatke van der Maas
role: PRINCIPAL_INVESTIGATOR
References: