NCT01713842

Tocilizumab Effect iN pOlymyalgia Rheumatica

Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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) .

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	TCZ	Tocilizumab at week 0, 4 and 8.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-10-25
• Last updated: 2015-02-11

Locations

3 sites across 1 country: France