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

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

February 15, 2017

Primary Completion Date

November 12, 2020

Study Completion Date

November 12, 2020

Conditions
Polymyalgia Rheumatica
Interventions
DRUG

Tocilizumab

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

Placebo

6 Intravenous infusions of placebo every 4 weeks.

Trial Locations (17)

13003

Hôpital européen, Marseille

25000

CIC Besançon, Besançon

25030

CHU Besançon, Besançon

29200

CHRU Brest, Brest

29600

Ch Des Pays de Morlaix, Morlaix

33076

CHU Bordeaux, Bordeaux

35203

CHU Rennes, Rennes

44093

CHU Nantes, Nantes

54511

CHU de Nancy, Nancy

67098

CHRU de Strasbourg, Strasbourg

72037

CH Le Mans, Le Mans

75013

hôpital Sapêtrière -APHP, Paris

90000

Hopital Nord service de rhumatologie-Franche Comté, Belfort

91106

Centre hospitalier Sud-Francilien, Corbeil-Essonnes

Unknown

CHU Dijon, Dijon

CH Mulhouse, Mulhouse

CHU St Etienne, Saint-Etienne

All Listed Sponsors
collaborator

Roche Chugai

INDUSTRY

lead

University Hospital, Brest

OTHER

NCT02908217 - Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE | Biotech Hunter | Biotech Hunter