Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse (REDUCE-PMR-2)
Primary Purpose
Polymyalgia Rheumatica
Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Rituximab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica
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) while treated with prednisolone ≤ 5mg/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.
Sites / Locations
- Sint MaartensklineikRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rituximab
Placebo
Arm Description
1000mg rituximab intravenously once
0mg rituximab (placebo) intravenously once
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of patients in glucocorticoid-free remission
Percentage of patients in glucocorticoid-free remission
Percentage of patients with glucocorticoid dose of ≤5mg/day
Percentage of patients with glucocorticoid dose of ≤5mg/day
Number of relapses
Number of relapses
Time to glucocorticoid-free remission
Time to glucocorticoid-free remission in days during the study period
Time to relapse
Time to relapse in days during the study period
Cumulative glucocorticoid dose
Cumulative glucocorticoid dose
Percentage of patients needing RTX/Placebo retreatment
Percentage of patients needing RTX/Placebo retreatment
Adverse events
Adverse events
Full Information
NCT ID
NCT05533164
First Posted
September 6, 2022
Last Updated
May 22, 2023
Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
1. Study Identification
Unique Protocol Identification Number
NCT05533164
Brief Title
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Acronym
REDUCE-PMR-2
Official Title
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Arm Description
1000mg rituximab intravenously once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0mg rituximab (placebo) intravenously once
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rixathon, MabThera, Ruxience, Truxima
Intervention Description
1000mg rituximab in 250ml NaCl 0.9% intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in 250ml NaCl 0.9% intravenously
Primary Outcome Measure Information:
Title
Between group difference in percentage of patients in glucocorticoid-free remission
Description
Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score < 10) at week 52
Time Frame
At week 52
Secondary Outcome Measure Information:
Title
Percentage of patients in glucocorticoid-free remission
Description
Percentage of patients in glucocorticoid-free remission
Time Frame
21 weeks
Title
Percentage of patients with glucocorticoid dose of ≤5mg/day
Description
Percentage of patients with glucocorticoid dose of ≤5mg/day
Time Frame
52 weeks
Title
Number of relapses
Description
Number of relapses
Time Frame
52 weeks
Title
Time to glucocorticoid-free remission
Description
Time to glucocorticoid-free remission in days during the study period
Time Frame
52 weeks
Title
Time to relapse
Description
Time to relapse in days during the study period
Time Frame
52 weeks
Title
Cumulative glucocorticoid dose
Description
Cumulative glucocorticoid dose
Time Frame
52 weeks
Title
Percentage of patients needing RTX/Placebo retreatment
Description
Percentage of patients needing RTX/Placebo retreatment
Time Frame
52 weeks
Title
Adverse events
Description
Adverse events
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Bovens
Phone
0031243272575
Email
p.bovens@maartenskliniek.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Noortje Kooijman
Phone
0031243272948
Email
n.kooijman@maartenskliniek.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aatke van der Maas
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartensklineik
City
Ubbergen
State/Province
Gelderland
ZIP/Postal Code
6574 NA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Bovens
Phone
0031243272575
Email
p.bovens@maartenskliniek.nl
First Name & Middle Initial & Last Name & Degree
Noortje Kooijman
Phone
0031243272948
Email
n.kooijman@maartenskliniek.nl
First Name & Middle Initial & Last Name & Degree
Aatke van der Maas
12. IPD Sharing Statement
Learn more about this trial
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
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