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 ]
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