Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

PHASE3TerminatedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

May 19, 2021

Study Completion Date

May 19, 2021

Conditions
Polymyalgia Rheumatica
Interventions
DRUG

Sarilumab SAR153191 (REGN88)

Pharmaceutical form:solution for injection Route of administration: subcutaneous

DRUG

Sarilumab-matching placebo

Pharmaceutical form:solution for injection Route of administration: subcutaneous

DRUG

Prednisone

Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration

DRUG

Prednisone-matching placebo

Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration

DRUG

Prednisone

Pharmaceutical form:tablets Route of administration: oral administration

Trial Locations (84)

2217

Investigational Site Number 0360001, Kogarah

3000

Investigational Site Number 0560001, Leuven

3010

Investigational Site Number 7560001, Bern

3079

Investigational Site Number 5280008, Rotterdam

3124

Investigational Site Number 0360003, Camberwell

4032

Investigational Site Number 3480001, Debrecen

4558

Investigational Site Number 0360002, Maroochydore

5011

Investigational Site Number 0360004, Woodville South

9000

Investigational Site Number 0560003, Ghent

9007

Investigational Site Number 7560002, Sankt Gallen

10117

Investigational Site Number 2760009, Berlin

11201

Investigational Site Number 8400022, New York

13125

Investigational Site Number 2760001, Berlin

13419

Investigational Site Number 2330001, Tallinn

14033

Investigational Site Number 2500011, Caen

15706

Investigational Site Number 7240004, A Coruña / Santiago de Compostela

18014

Investigational Site Number 7240008, Granada

20089

Investigational Site Number 3800005, Rozzano

20122

Investigational Site Number 3800003, Milan

20132

Investigational Site Number 3800001, Milan

28041

Investigational Site Number 7240002, Madrid

28905

Investigational Site Number 7240001, Getafe

29609

Investigational Site Number 2500005, Brest

31059

Investigational Site Number 2500014, Toulouse

31096

Investigational Site Number 3760001, Haifa

33486

Investigational Site Number 8400002, Boca Raton

34295

Investigational Site Number 2500003, Montpellier

34362

Investigational Site Number 3760004, Haifa

37134

Investigational Site Number 3800008, Verona

39008

Investigational Site Number 7240006, Santander

42100

Investigational Site Number 3800002, Reggio Emilia

44281

Investigational Site Number 3760003, Kfar Saba

46026

Investigational Site Number 7240007, Valencia

49100

Investigational Site Number 3760002, Petah Tikva

52242

Investigational Site Number 8400014, Iowa City

52621

Investigational Site Number 3760005, Tel Litwinsky

56126

Investigational Site Number 3800004, Pisa

59037

Investigational Site Number 2500010, Lille

69495

Investigational Site Number 2500016, Pierre-Bénite

72076

Investigational Site Number 2760007, Tübingen

73230

Investigational Site Number 2760003, Kirchheim unter Teck

75013

Investigational Site Number 2500004, Paris

75231

Investigational Site Number 8400011, Dallas

75904

Investigational Site Number 8400025, Lufkin

76290

Investigational Site Number 2500002, Montivilliers

80230

Investigational Site Number 8400005, Denver

80336

Investigational Site Number 2760004, München

91786

Investigational Site Number 8400003, Upland

93077

Investigational Site Number 2760008, Bad Abbach

94270

Investigational Site Number 2500015, Le Kremlin-Bicêtre

99024

Investigational Site Number 8400015, Spokane

115404

Investigational Site Number 6430002, Moscow

121374

Investigational Site Number 6430001, Moscow

123182

Investigational Site Number 6430003, Moscow

129110

Investigational Site Number 6430004, Moscow

192242

Investigational Site Number 6430008, Saint Petersburg

06905

Investigational Site Number 8400009, Stamford

02114

Investigational Site Number 8400006, Boston

C1015ABO

Investigational Site Number 0320001, Buenos Aires

C1121ABE

Investigational Site Number 0320005, Buenos Aires

C1181ACH

Investigational Site Number 0320002, Caba

T4000AXL

Investigational Site Number 0320003, San Miguel de Tucumán

L8N 1Y2

Investigational Site Number 1240007, Hamilton

H4A 3T2

Investigational Site Number 1240010, Montreal

G5L 5T1

Investigational Site Number 1240001, Rimouski

J1G 2E8

Investigational Site Number 1240005, Sherbrooke

G8Z 1Y2

Investigational Site Number 1240003, Trois-Rivières

01307

Investigational Site Number 2760002, Dresden

Unknown

Investigational Site Number 3920002, Fuchu-Shi

Investigational Site Number 3920003, Kamakura-Shi

Investigational Site Number 3920005, Kawachinagano-Shi

Investigational Site Number 3920001, Takasaki-Shi

1815 JD

Investigational Site Number 5280003, Alkmaar

7609 PP

Investigational Site Number 5280002, Almelo

8934 AD

Investigational Site Number 5280005, Leeuwarden

6522 JV

Investigational Site Number 5280004, Nijmegen

2545 CH

Investigational Site Number 5280007, The Hague

08916

Investigational Site Number 7240005, Badalona

NE9 6SX

Investigational Site Number 8260004, Gateshead

LS7 4SA

Investigational Site Number 8260003, Leeds

M23 9LT

Investigational Site Number 8260009, Manchester

PO30 5TG

Investigational Site Number 8260007, Newport

PL6 8DH

Investigational Site Number 8260002, Plymouth

SS0 0RY

Investigational Site Number 8260001, Southend

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY