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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University Hospital, Brest

Current Primary Outcome: Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24). [ Time Frame: From week 0 to week 24 ]

PMR-AS measure


Original Primary Outcome: Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg (absolute value) or decrease ≥ 10 mg from week 0 to week 24). [ Time Frame: From week 0 to week 24 ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Proportion of patients with (PMR-AS>17) in both arm [ Time Frame: From Week 24 to Week 32 ]
  • PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17. [ Time Frame: From inclusion to week 32 ]
  • Cumulative dosages of GCs at Week 32 [ Time Frame: Week 32 ]


Information By: University Hospital, Brest

Dates:
Date Received: September 16, 2016
Date Started: February 15, 2017
Date Completion: January 2021
Last Updated: April 5, 2017
Last Verified: February 2017