Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

Polymyalgia Rheumatica Clinical Trial

— REDUCE-PMR-2  

Official title:

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533164
• Other study ID #: REDUCE-PMR-2
• Status: Recruiting
• Phase: Phase 3
• Start date: February 9, 2023
• Est. completion date: January 2027

Study information

• Verified date: May 2023
• Source: Sint Maartenskliniek
• Contact: Pauline Bovens
• Phone: 0031243272575
• Email: p.bovens[@]maartenskliniek.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Rituximab
1000mg rituximab in 250ml NaCl 0.9% intravenously
• Placebo
Placebo in 250ml NaCl 0.9% intravenously

Locations

Country	Name	City	State
Netherlands	Sint Maartensklineik	Ubbergen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Sint Maartenskliniek	Dutch Arthritis Association, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between group difference in percentage of patients in glucocorticoid-free remission	Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score < 10) at week 52	At week 52
Secondary	Percentage of patients in glucocorticoid-free remission	Percentage of patients in glucocorticoid-free remission	21 weeks
Secondary	Percentage of patients with glucocorticoid dose of =5mg/day	Percentage of patients with glucocorticoid dose of =5mg/day	52 weeks
Secondary	Number of relapses	Number of relapses	52 weeks
Secondary	Time to glucocorticoid-free remission	Time to glucocorticoid-free remission in days during the study period	52 weeks
Secondary	Time to relapse	Time to relapse in days during the study period	52 weeks
Secondary	Cumulative glucocorticoid dose	Cumulative glucocorticoid dose	52 weeks
Secondary	Percentage of patients needing RTX/Placebo retreatment	Percentage of patients needing RTX/Placebo retreatment	52 weeks
Secondary	Adverse events	Adverse events	52 weeks