Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Study Overview
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Brief Summary
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Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS. The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale). All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

Official Title
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Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

Conditions
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Polymyalgia Rheumatica

Intervention / Treatment
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* Drug: Tocilizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 50 years Fulfilled the Chuang criteria And currently: PMR-AS> 10 Absence of signs or symptoms of other musculoskeletal or connective tissue conditions Able to give informed consent Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months. Exclusion Criteria: Clinical symptoms of giant cell arteritis Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease History of major organ or haematopoietic stem cell/marrow transplant Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR Planned surgical procedure within 12 months after randomization. History of malignant neoplasm within the last 5 years. Current active infection Patient with elevated ALT or AST> 5 ULN

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocilizumab<br>6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks. | Drug: Tocilizumab<br>* 6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.<br>* Other names: Intravenous infusions of tocilizumab;|
| Placebo Comparator: Placebo<br>6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks | Drug: Placebo<br>* 6 Intravenous infusions of placebo every 4 weeks.<br>* Other names: Intravenous infusions of placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24). | PMR-AS measure | From week 0 to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with (PMR-AS>17) in both arm | PMR-AS measure | From Week 24 to Week 32 | 
| PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. | PMR-AS measure | From inclusion to week 32 | 
| Cumulative dosages of GCs at Week 32 | dosages of GCs | Week 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polymyalgia Rheumatica, Tocilizumab, Glucocorticoid