Polymyalgia Rheumatica Clinical Trial
Official title:
Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)
Phase 1:
Patients are treated with infusions of Tocilizumab (TCZ) for 3 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).
At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.
Phase 2:
All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3
months. Two arms are possible according to the PMR-AS. Either the classical GC treatment
(0.3mg/kg), either a low dose group of GC(0.15mg/kg) .
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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