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| Name | Class |
|---|---|
| Dutch Arthritis Association | INDUSTRY |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | 1000mg rituximab intravenously once |
|
| Placebo | Placebo Comparator | 0mg rituximab (placebo) intravenously once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in glucocorticoid-free remission | Percentage of patients in glucocorticoid-free remission | 21 weeks |
| Percentage of patients with glucocorticoid dose of ≤5mg/day | Percentage of patients with glucocorticoid dose of ≤5mg/day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aatke van der Maas, MD PhD | Sint Maartenskliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Maartensklineik | Ubbergen | Gelderland | 6574 NA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39400109 | Derived | 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. |
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| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | Placebo in 250ml NaCl 0.9% intravenously with usual premedication |
|
| 52 weeks |
| Number of relapses | Number of relapses | 52 weeks |
| Time to glucocorticoid-free remission | Time to glucocorticoid-free remission in days during the study period | 52 weeks |
| Time to relapse | Time to relapse in days during the study period | 52 weeks |
| Cumulative glucocorticoid dose | Cumulative glucocorticoid dose | 52 weeks |
| Percentage of patients needing RTX/Placebo retreatment | Percentage of patients needing RTX/Placebo retreatment | 52 weeks |
| Adverse events | Adverse events | 52 weeks |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |