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

NCT02908217

CompletedPhase 3

Sponsor: University Hospital, Brest

Conditions: Polymyalgia Rheumatica

Interventions: Tocilizumab, Placebo

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (17)
  • Belfort, France
  • Besançon, France
  • Besançon, France
  • Bordeaux, France
  • Brest, France
  • Corbeil-Essonnes, France
  • Dijon, France
  • Le Mans, France
  • Marseille, France
  • Morlaix, France
  • Mulhouse, France
  • Nancy, France
  • Nantes, France
  • Paris, France
  • Rennes, France
  • Saint-Etienne, France
  • Strasbourg, France