Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica

Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Sint Maartensklineik
Ubbergen
Time Frame
Start Date: 2023-02-01
Completion Date: 2026-04
Participants
Target number of participants: 114
Treatments
Experimental: Rituximab
1000mg rituximab intravenously once
Placebo_comparator: Placebo
0mg rituximab (placebo) intravenously once
Sponsors
Collaborators: Dutch Arthritis Association, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Sint Maartenskliniek

This content was sourced from clinicaltrials.gov

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