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

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.

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