Polymyalgia RheumaticaPhase 3REDUCE-PMR-2NCT05533164
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
A Phase 3 study testing Rituximab in people with Polymyalgia Rheumatica, run by Sint Maartenskliniek at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Feb 2023to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Rituximab, Placebo
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rixathon, MabThera, Ruxience, Truxima
1000mg rituximab in 250ml NaCl 0.9% intravenously
PlaceboDrug
Placebo in 250ml NaCl 0.9% intravenously
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | 1000mg rituximab intravenously once Receives: Drug: Rituximab |
| Placebo | Placebo comparator | 0mg rituximab (placebo) intravenously once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 52
Secondary outcomes (8)
Percentage of patients in glucocorticoid-free remission
Percentage of patients in glucocorticoid-free remission
Measured: 21 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
Percentage of patients with glucocorticoid dose of ≤5mg/day
Measured: 52 weeks
Number of relapses
Number of relapses
Measured: 52 weeks
Time to glucocorticoid-free remission
Time to glucocorticoid-free remission in days during the study period
Measured: 52 weeks
Time to relapse
Time to relapse in days during the study period
Measured: 52 weeks
Cumulative glucocorticoid dose
Cumulative glucocorticoid dose
Measured: 52 weeks
Percentage of patients needing RTX/Placebo retreatment
Percentage of patients needing RTX/Placebo retreatment
Measured: 52 weeks
Adverse events
Adverse events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start9 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
- Responsible party
- Sponsor
- Investigators
- Aatke van der Maas, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533164
- Sponsor's protocol ID
- REDUCE-PMR-2
- Acronym
- REDUCE-PMR-2
- Status last verified
- Feb 2026
- First submitted
- 6 Sep 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.
PubMed 39400109
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
- ClinicalTrials.gov ID
- NCT05533164
- Acronym / sponsor ID
- REDUCE-PMR-2 / REDUCE-PMR-2
- Conditions
- Polymyalgia Rheumatica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab1000mg rituximab intravenously once |
| Placebo | Placebo comparator | Drug: Placebo0mg rituximab (placebo) intravenously once |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Rixathon, MabThera, Ruxience, Truxima1000mg rituximab in 250ml NaCl 0.9% intravenously | Drug | Rituximab |
| PlaceboPlacebo in 250ml NaCl 0.9% intravenously | Drug | Placebo |
Primary outcome
Between group difference in percentage of patients in glucocorticoid-free remission
Time frame: At week 52
Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score < 10) at week 52
8 secondary outcomes
Percentage of patients in glucocorticoid-free remission
Time frame: 21 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
Time frame: 52 weeks
Number of relapses
Time frame: 52 weeks
Time to glucocorticoid-free remission
Time frame: 52 weeks
Time to relapse
Time frame: 52 weeks
Cumulative glucocorticoid dose
Time frame: 52 weeks
Percentage of patients needing RTX/Placebo retreatment
Time frame: 52 weeks
Adverse events
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 39400109Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aatke van der Maas principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab in people with Polymyalgia Rheumatica, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group difference in percentage of patients in glucocorticoid-free remission (time frame: At week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05533164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.