A Phase 3 interventional study of Tocilizumab and Placebo in Polymyalgia Rheumatica, sponsored by University Hospital, Brest. Completed at 17 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Supportive care
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.
135 studies on the registry are indexed under Polymyalgia Rheumatica; 28 are open to participants now.
This study's enrollment of 113 is above the median of 60 across 68 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
And currently:
Exclusion Criteria:
6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
Drug: Tocilizumab
6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks
Drug: Placebo
6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
Also known as: Intravenous infusions of tocilizumab
6 Intravenous infusions of placebo every 4 weeks.
Also known as: Intravenous infusions of placebo
Low disease activity (PMR-AS<10) with steroid independence (GCs ≤5 mg absolute value) or decrease ≥ 10 mg from week 0 to week 24).
PMR-AS measure
Time frame: From week 0 to week 24
Proportion of patients with (PMR-AS>17) in both arm
PMR-AS measure
Time frame: From Week 24 to Week 32
PMR-AS and proportion of patients with PMR-AS < 1.5; 10; 17.
PMR-AS measure
Time frame: From inclusion to week 32
Cumulative dosages of GCs at Week 32
dosages of GCs
Time frame: Week 32
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest