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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
113
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.
6 Intravenous infusions of placebo every 4 weeks.
Hopital Nord service de rhumatologie-Franche Comté
Belfort, France
CIC Besançon
Besançon, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHRU Brest
Brest, France
Centre hospitalier Sud-Francilien
Corbeil-Essonnes, France
CHU Dijon
Dijon, France
CH Le Mans
Le Mans, France
Hôpital européen
Marseille, France
Ch Des Pays de Morlaix
Morlaix, France
...and 7 more locations
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
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