A Phase 3 interventional study of Rituximab and Placebo in Polymyalgia Rheumatica, sponsored by Sint Maartenskliniek. Active, not recruiting at 1 site in Netherlands. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Sint Maartenskliniek · Phase 3, Interventional, and Treatment
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.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's planned enrollment of 174 is above the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →Sint Maartenskliniek is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1000mg rituximab intravenously once
Drug: Rituximab
0mg rituximab (placebo) intravenously once
Drug: Placebo
1000mg rituximab in 250ml NaCl 0.9% intravenously
Also known as: Rixathon, MabThera, Ruxience, Truxima
Placebo in 250ml NaCl 0.9% intravenously
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
Time frame: At week 52
Percentage of patients in glucocorticoid-free remission
Percentage of patients in glucocorticoid-free remission
Time frame: 21 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
Percentage of patients with glucocorticoid dose of ≤5mg/day
Time frame: 52 weeks
Number of relapses
Number of relapses
Time frame: 52 weeks
Time to glucocorticoid-free remission
Time to glucocorticoid-free remission in days during the study period
Time frame: 52 weeks
Time to relapse
Time to relapse in days during the study period
Time frame: 52 weeks
Cumulative glucocorticoid dose
Cumulative glucocorticoid dose
Time frame: 52 weeks
Percentage of patients needing RTX/Placebo retreatment
Percentage of patients needing RTX/Placebo retreatment
Time frame: 52 weeks
Adverse events
Adverse events
Time frame: 52 weeks
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Sint Maartenskliniek