A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

PHASE3CompletedINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

November 20, 2015

Primary Completion Date

January 15, 2018

Study Completion Date

February 4, 2019

Conditions
Systemic Sclerosis
Interventions
DRUG

Placebo

Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.

DRUG

Tocilizumab

Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.

Trial Locations (83)

1023

National Institute of Rheumatology and Physiology, Budapest

1612

MHAT St.Ivan Rilski; Rheumtology Department, Sofia

MHAT Sv.Ivan Rilski; Clinic of Rheumatology, Sofia

2400

Bispebjerg Hospital, Dermatologisk afdeling, København NV

3000

UZ Leuven Gasthuisberg, Leuven

4000

Centro de Investigaciones Reumatologicas Tucuman, San Miguel de Tucumán

4002

MHAT Kaspela; Rheumatology, Plovdiv

4003

MHAT-Plovdiv AD; Reumatology Department, Plovdiv

4031

Universitätsspital Basel; Rheumatologische Poliklinik, Basel

7632

Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika, Pécs

8091

Universitätsspital Zürich; Klinik für Rheumatologie, Zurich

8200

Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme, Aarhus N

9000

UZ Gent, Ghent

19131

Thomas Jefferson Uni ; Division of Rheumatology, Philadelphia

19610

Clinical Research Center of Reading, Wyomissing

20007

Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept., Washington D.C.

20122

Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica, Milan

28007

Hospital General Universitario Gregorio Marañon; Servicio de Reumatología, Madrid

28204

Joint & Muscle Research Institute, Charlotte

32174

Millenium Research, Ormond Beach

33486

Rheumatology Assoc. of S. Florida - Clinical Research Center, Boca Raton

38305

West Tennessee Research Institute, Jackson

44620

Unidad De Enfermedades; Cronico Degenerativas, SC., México

49546

West Michigan Rheumatology, PLLC, Grand Rapids

50139

Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia, Florence

59037

Hopital Claude Huriez; Internal Medicine, Lille

61231

Kerckhoff-Klinik; Rheumatologie&klin.Immunologie, Bad Nauheim

72076

Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II, Tübingen

73103

Arthritis and Rheumatology; Center of Oklahoma PLLC, Oklahoma City

75231

Metroplex Clinical Research, Dallas

80131

Policlinico Universitario-II Università di Napoli; Reumatologia, Napoli

80336

Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV, München

90025

Univ of Calif., Los Angeles; Rheumatology, Los Angeles

90045

Arthritis Associates of Southern California, Los Angeles

92020

TriWest Research Associates, LLC, El Cajon

92835

St. Joseph's Heritage Healthcare, Fullerton

93077

Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie, Bad Abbach

400006

Spitalul Judetean Cluj; Sectia de Reumatologie, Cluj-Napoca

02118

Boston Univ Med Center - AC, Boston

48109-0934

University of Michigan, Ann Arbor

C1015ABO

Organizacion Medica de Investigacion, Buenos Aires

C1280AEB

Hospital Britanico; Haematology, Buenos Aires

S2000DSV

Sanatorio Parque S.A., Rosario, Santa FE

V6Z 1Y6

St. Paul's Hospital University of British Colambia Division of Hematology, Vancouver

M5G 1X5

Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease, Toronto

01307

Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III, Dresden

115 27

Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens

265 04

University Hospital of Patras; Rheumatology, Pátrai

00168

Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica, Rome

371-8511

Gunma University Hospital, Gunma

060-8543

Sapporo Medical University Hospital, Hokkaido

060-8648

Hokkaido University Hospital, Hokkaido

920-8641

Kanazawa University Hospital, Ishikawa

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa

807-8556

Hospital of the University of Occupational and Environmental Health,Japan, Kitakyushu-shi

860-8556

Kumamoto University Hospital, Kumamoto

980-8574

Tohoku University Hospital, Miyagi

565-0871

Osaka University Hospital, Osaka

113-8603

Nippon Medical School Hospital, Tokyo

113-8655

The University of Tokyo Hospital, Tokyo

LT - 92288

Klaipeda University Hospital; Department of Rheumatology, Klaipėda

08661

Vilnius University Hospital Santariskiu Clinic Public Insti, Vilnius

Tlalpan 14000

Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán, Mexico City

06700

Cliditer SA de CV, Miexico City

2333 ZA

Academisch Ziekenhuis Leiden; Dept of Rheumatology, Leiden

85-168

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii, Gdansk

40-635

Gornoslaskie Centrum Medyczne, Katowice

31-121

Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi, Krakow

20-954

SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki, Lublin

02-637

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher, Warsaw

2801-951

Hospital Garcia de Orta; Servico de Reumatologia, Almada

3814-501

Hospital Prof. Dr. Fernando Fonseca; Medicina IV, Amadora

00936-5067

Puerto Rico Clinical & Translational Research Consortium, San Juan

020475

Cantacuzino Hospital; Department of Internal Medicine and Rheumatology, Bucharest

08025

Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia, Barcelona

08035

Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna, Barcelona

B15 2TH

Queen Elizabeth Hospital; Rheumatology Dept., Birmingham

EH4 2XU

Western General Hospital, Edinburgh

LS7 4SA

Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine, Leeds

L9 7AL

Uni Hospital Aintree; Academic Rheumatology Unit, Liverpool

NW3 2QG

Royal Free Hospital; Department of Rheumatology, London

NE7 7DN

Freeman Hospital; Musculoskeletal Unit, Newcastle upon Tyne

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02453256 - A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) | Biotech Hunter | Biotech Hunter