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

Last updated: March 5, 2020
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Scleroderma

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT02453256
WA29767
2015-000424-28
  • Ages > 18
  • All Genders

Study Summary

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of SSc according to American College of Rheumatology (ACR) and EuropeanLeague Against Rheumatism (EULAR) criteria, meeting criteria for active disease andwith total disease duration of less than or equal to (</=) 60 months

  • mRSS of 10-35 units, inclusive

  • Agreement to remain abstinent or use an effective contraceptive method among males andfemales with childbearing potential

Exclusion

Exclusion Criteria:

  • Pregnant or lactating females

  • Major surgery within 8 weeks prior to screening

  • Scleroderma limited to the face or areas distal to the elbows or knees

  • Rheumatic autoimmune disease other than SSc

  • Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline

  • Known hypersensitivity to human, humanized, or murine monoclonal antibodies

  • Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, orgastrointestinal (GI) disease not related to SSc, including diverticulitis orulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior toscreening

  • Active or significant history of infection, including treatment with intravenous (IV)antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening

  • Significant history of tuberculosis (TB)

  • Primary or secondary immunodeficiency

  • Malignant disease, with the exception of excised/cured local basal or squamous cellcarcinoma of the skin or carcinoma in situ of the uterine cervix

  • History of drug or alcohol abuse

Study Design

Total Participants: 212
Study Start date:
November 20, 2015
Estimated Completion Date:
February 04, 2019

Connect with a study center

  • Hospital Britanico; Haematology

    Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO
    Argentina

    Site Not Available

  • Consultora Integral de Salud SRL

    Cordoba, 5000
    Argentina

    Site Not Available

  • Sanatorio Parque S.A.

    Rosario, Santa FE, S2000DSV
    Argentina

    Site Not Available

  • Centro de Investigaciones Reumatologicas Tucuman

    Tucuman, 4000
    Argentina

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • empty

    Goiania, GO 74110010
    Brazil

    Site Not Available

  • empty

    Juiz de Fora, MG 36036-330
    Brazil

    Site Not Available

  • empty

    Porto Alegre, RS 90480-000
    Brazil

    Site Not Available

  • empty

    Ribeirao Preto, SP 14048-900
    Brazil

    Site Not Available

  • empty

    Sao Paulo, SP 04026-000
    Brazil

    Site Not Available

  • MHAT Kaspela; Rheumatology

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT-Plovdiv AD; Reumatology Department

    Plovdiv, 4003
    Bulgaria

    Site Not Available

  • MHAT St.Ivan Rilski; Rheumtology Department

    Sofia, 1612
    Bulgaria

    Site Not Available

  • MHAT Sv.Ivan Rilski; Clinic of Rheumatology

    Sofia, 1612
    Bulgaria

    Site Not Available

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

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

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

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • empty

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Clinical Hospital Split; Department of Rheumatology and Physical medicine

    Split, 21000
    Croatia

    Site Not Available

  • Clinical Hospital Dubrava; Department of Clinical Immunology and Rheumatology

    Zagreb, 10000
    Croatia

    Site Not Available

  • Aarhus Universitetshospital, Dermato-Venerologisk Afd. S.

    Aarhus C, 8000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Bispebjerg Hospital, Dermatologisk afdeling

    København NV, 2400
    Denmark

    Site Not Available

  • Hopital Claude Huriez; Internal Medicine

    Lille, 59037
    France

    Site Not Available

  • empty

    Paris, 75679
    France

    Site Not Available

  • empty

    Strasbourg, 67098
    France

    Site Not Available

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

    Bad Abbach, 93077
    Germany

    Site Not Available

  • Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • CHARITÉ- Campus Mitte; Med. Klinik mit SP Rheumatologie & Immunologie

    Berlin, 10117
    Germany

    Site Not Available

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

    Dresden, 01307
    Germany

    Site Not Available

  • Asklepios Klinik Altona; Rheuma, Klinische Immunologie, Nephrologie

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein; Campus Lübeck

    Lübeck, 23538
    Germany

    Site Not Available

  • empty

    Muenchen, 80336
    Germany

    Site Not Available

  • Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

    München, 80336
    Germany

    Site Not Available

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

    Tübingen, 72076
    Germany

    Site Not Available

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

    Athens, 115 27
    Greece

    Site Not Available

  • University Hospital of Patras; Rheumatology

    Patras, 265 04
    Greece

    Site Not Available

  • National Institute of Rheumatology and Physiology

    Budapest, 1023
    Hungary

    Site Not Available

  • University of Debrecen, Medical Center; Third Department of Medicine, Rheumatology Division

    Debrecen, 4004
    Hungary

    Site Not Available

  • Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika

    Pécs, 7632
    Hungary

    Site Not Available

  • Policlinico Universitario-II Università di Napoli; Reumatologia

    Napoli, Campania 80131
    Italy

    Site Not Available

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

    Roma, Lazio 00168
    Italy

    Site Not Available

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

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Ospedale Regionale Torrette; SOD Clinica Medica del Dipartimento di Medicina Interna e Specialisti

    Ancona, Marche 60020
    Italy

    Site Not Available

  • Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche

    Verona, Veneto 37134
    Italy

    Site Not Available

  • Chukyo Hospital

    Aichi, 457-8510
    Japan

    Site Not Available

  • Gunma University Hospital

    Gunma, 371-8511
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Ishikawa, 920-8641
    Japan

    Site Not Available

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • empty

    Kanazawa, 920-8641
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8556
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • empty

    Kyoto, 606-8507
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • empty

    Sapporo-shi, 060-8648
    Japan

    Site Not Available

  • empty

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Tokyo, 113-8603
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Tokyo, 113-8655
    Japan

    Site Not Available

  • Klaipeda University Hospital; Department of Rheumatology

    Klaipeda, LT - 92288
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Clinic Public Insti

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Unidad De Enfermedades; Cronico Degenerativas, SC.

    Mexico, 44620
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

    Mexico City, Tlalpan 14000
    Mexico

    Site Not Available

  • Cliditer SA de CV

    Miexico City, 06700
    Mexico

    Site Not Available

  • Academisch Ziekenhuis Leiden; Dept of Rheumatology

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • empty

    Rotterdam, 3079 DZ
    Netherlands

    Site Not Available

  • Academisch Medisch Centrum Utrecht, Afdeling Reumatologie; Department Reumatologie

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

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

    Bydgoszcz, 85-168
    Poland

    Site Not Available

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

    Gdansk, 80-952
    Poland

    Site Not Available

  • Gornoslaskie Centrum Medyczne

    Katowice, 40-635
    Poland

    Site Not Available

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

    Krakow, 31-121
    Poland

    Site Not Available

  • SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki

    Lublin, 20-954
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego

    Szczecin, 71-242
    Poland

    Site Not Available

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

    Warszawa, 02-637
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-556
    Poland

    Site Not Available

  • Hospital Garcia de Orta; Servico de Reumatologia

    Almada, 2801-951
    Portugal

    Site Not Available

  • Hospital Prof. Dr. Fernando Fonseca; Medicina IV

    Amadora, 3814-501
    Portugal

    Site Not Available

  • Puerto Rico Clinical & Translational Research Consortium

    San Juan, 00936-5067
    Puerto Rico

    Site Not Available

  • Cantacuzino Hospital; Department of Internal Medicine and Rheumatology

    Bucharest, 020475
    Romania

    Site Not Available

  • Spitalul Judetean Cluj; Sectia de Reumatologie

    Cluj-napoca, 400006
    Romania

    Site Not Available

  • empty

    Cape Town, 7925
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Hospital; Rheumatology Department

    Diepkloof, 1862
    South Africa

    Site Not Available

  • Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

    Barcelona, 08035
    Spain

    Site Not Available

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

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Universitario San Cecilio; Unidad de Enfermedades Autoinmunes Sistemicas

    Granada, 18012
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

    Madrid, 28007
    Spain

    Site Not Available

  • Universitätsspital Basel; Rheumatologische Poliklinik

    Basel, 4031
    Switzerland

    Site Not Available

  • Universitätsspital Zürich; Klinik für Rheumatologie

    Zürich, 8091
    Switzerland

    Site Not Available

  • empty

    Bath, BA1 1RL
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital; Rheumatology Dept.

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • Uni Hospital Aintree; Academic Rheumatology Unit

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Royal Free Hospital; Department of Rheumatology

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Freeman Hospital; Musculoskeletal Unit

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • empty

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • TriWest Research Associates, LLC

    El Cajon, California 92020
    United States

    Site Not Available

  • St. Joseph's Heritage Healthcare

    Fullerton, California 92835
    United States

    Site Not Available

  • Arthritis Associates of Southern California

    Los Angeles, California 90045
    United States

    Site Not Available

  • Univ of Calif., Los Angeles; Rheumatology

    Los Angeles, California 90025
    United States

    Site Not Available

  • St. Joseph's Heritage Healthcare

    Orange, California 92868
    United States

    Site Not Available

  • empty

    Palo Alto, California 94304
    United States

    Site Not Available

  • empty

    Redwood City, California 94063
    United States

    Site Not Available

  • empty

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • Rheumatology Assoc. of S. Florida - Clinical Research Center

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Millenium Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Arthritis Center Palm Harbor

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Boston Univ Med Center - AC

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109-0934
    United States

    Site Not Available

  • West Michigan Rheumatology, PLLC

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • empty

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Steffens Scleroderma Center

    Albany, New York 12206
    United States

    Site Not Available

  • Joint & Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Arthritis and Rheumatology; Center of Oklahoma PLLC

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Thomas Jefferson Uni ; Division of Rheumatology

    Philadelphia, Pennsylvania 19131
    United States

    Site Not Available

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Metroplex Clinical Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Texas Rheumatology Clinic

    Houston, Texas 77030
    United States

    Site Not Available

  • Swedish Research Center

    Seattle, Washington 98122
    United States

    Site Not Available

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