Phase
Condition
Scleroderma
Collagen Vascular Diseases
Connective Tissue Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Hospital Britanico; Haematology
Buenos Aires, C1280AEB
ArgentinaSite Not Available
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
ArgentinaSite Not Available
Consultora Integral de Salud SRL
Cordoba, 5000
ArgentinaSite Not Available
Sanatorio Parque S.A.
Rosario, Santa FE, S2000DSV
ArgentinaSite Not Available
Centro de Investigaciones Reumatologicas Tucuman
Tucuman, 4000
ArgentinaSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
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Goiania, GO 74110010
BrazilSite Not Available
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Juiz de Fora, MG 36036-330
BrazilSite Not Available
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Porto Alegre, RS 90480-000
BrazilSite Not Available
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Ribeirao Preto, SP 14048-900
BrazilSite Not Available
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Sao Paulo, SP 04026-000
BrazilSite Not Available
MHAT Kaspela; Rheumatology
Plovdiv, 4002
BulgariaSite Not Available
MHAT-Plovdiv AD; Reumatology Department
Plovdiv, 4003
BulgariaSite Not Available
MHAT St.Ivan Rilski; Rheumtology Department
Sofia, 1612
BulgariaSite Not Available
MHAT Sv.Ivan Rilski; Clinic of Rheumatology
Sofia, 1612
BulgariaSite Not Available
St. Paul's Hospital University of British Colambia Division of Hematology
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease
Toronto, Ontario M5G 1X5
CanadaSite Not Available
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Montreal, Quebec H3T 1E2
CanadaSite Not Available
Clinical Hospital Split; Department of Rheumatology and Physical medicine
Split, 21000
CroatiaSite Not Available
Clinical Hospital Dubrava; Department of Clinical Immunology and Rheumatology
Zagreb, 10000
CroatiaSite Not Available
Aarhus Universitetshospital, Dermato-Venerologisk Afd. S.
Aarhus C, 8000
DenmarkSite Not Available
Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme
Aarhus N, 8200
DenmarkSite Not Available
Bispebjerg Hospital, Dermatologisk afdeling
København NV, 2400
DenmarkSite Not Available
Hopital Claude Huriez; Internal Medicine
Lille, 59037
FranceSite Not Available
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Paris, 75679
FranceSite Not Available
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Strasbourg, 67098
FranceSite Not Available
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie
Bad Abbach, 93077
GermanySite Not Available
Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
Bad Nauheim, 61231
GermanySite Not Available
CHARITÉ- Campus Mitte; Med. Klinik mit SP Rheumatologie & Immunologie
Berlin, 10117
GermanySite Not Available
Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III
Dresden, 01307
GermanySite Not Available
Asklepios Klinik Altona; Rheuma, Klinische Immunologie, Nephrologie
Hamburg, 22763
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, 23538
GermanySite Not Available
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Muenchen, 80336
GermanySite Not Available
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
München, 80336
GermanySite Not Available
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Tübingen, 72076
GermanySite Not Available
Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens
Athens, 115 27
GreeceSite Not Available
University Hospital of Patras; Rheumatology
Patras, 265 04
GreeceSite Not Available
National Institute of Rheumatology and Physiology
Budapest, 1023
HungarySite Not Available
University of Debrecen, Medical Center; Third Department of Medicine, Rheumatology Division
Debrecen, 4004
HungarySite Not Available
Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
Pécs, 7632
HungarySite Not Available
Policlinico Universitario-II Università di Napoli; Reumatologia
Napoli, Campania 80131
ItalySite Not Available
Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica
Roma, Lazio 00168
ItalySite Not Available
Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica
Milano, Lombardia 20122
ItalySite Not Available
Ospedale Regionale Torrette; SOD Clinica Medica del Dipartimento di Medicina Interna e Specialisti
Ancona, Marche 60020
ItalySite Not Available
Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia
Firenze, Toscana 50139
ItalySite Not Available
A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche
Verona, Veneto 37134
ItalySite Not Available
Chukyo Hospital
Aichi, 457-8510
JapanSite Not Available
Gunma University Hospital
Gunma, 371-8511
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, 060-8648
JapanSite Not Available
Sapporo Medical University Hospital
Hokkaido, 060-8543
JapanSite Not Available
Kanazawa University Hospital
Ishikawa, 920-8641
JapanSite Not Available
St. Marianna University School of Medicine Hospital
Kanagawa, 216-8511
JapanSite Not Available
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Kanazawa, 920-8641
JapanSite Not Available
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, 807-8556
JapanSite Not Available
Kumamoto University Hospital
Kumamoto, 860-8556
JapanSite Not Available
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Kyoto, 606-8507
JapanSite Not Available
Tohoku University Hospital
Miyagi, 980-8574
JapanSite Not Available
Osaka University Hospital
Osaka, 565-0871
JapanSite Not Available
empty
Sapporo-shi, 060-8648
JapanSite Not Available
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Sendai-shi, 980-8574
JapanSite Not Available
Nippon Medical School Hospital
Tokyo, 113-8603
JapanSite Not Available
The University of Tokyo Hospital
Tokyo, 113-8655
JapanSite Not Available
Klaipeda University Hospital; Department of Rheumatology
Klaipeda, LT - 92288
LithuaniaSite Not Available
Vilnius University Hospital Santariskiu Clinic Public Insti
Vilnius, 08661
LithuaniaSite Not Available
Unidad De Enfermedades; Cronico Degenerativas, SC.
Mexico, 44620
MexicoSite Not Available
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, Tlalpan 14000
MexicoSite Not Available
Cliditer SA de CV
Miexico City, 06700
MexicoSite Not Available
Academisch Ziekenhuis Leiden; Dept of Rheumatology
Leiden, 2333 ZA
NetherlandsSite Not Available
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Rotterdam, 3079 DZ
NetherlandsSite Not Available
Academisch Medisch Centrum Utrecht, Afdeling Reumatologie; Department Reumatologie
Utrecht, 3584 CX
NetherlandsSite Not Available
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, 85-168
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii
Gdansk, 80-952
PolandSite Not Available
Gornoslaskie Centrum Medyczne
Katowice, 40-635
PolandSite Not Available
Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi
Krakow, 31-121
PolandSite Not Available
SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki
Lublin, 20-954
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego
Szczecin, 71-242
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warszawa, 02-637
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
PolandSite Not Available
Hospital Garcia de Orta; Servico de Reumatologia
Almada, 2801-951
PortugalSite Not Available
Hospital Prof. Dr. Fernando Fonseca; Medicina IV
Amadora, 3814-501
PortugalSite Not Available
Puerto Rico Clinical & Translational Research Consortium
San Juan, 00936-5067
Puerto RicoSite Not Available
Cantacuzino Hospital; Department of Internal Medicine and Rheumatology
Bucharest, 020475
RomaniaSite Not Available
Spitalul Judetean Cluj; Sectia de Reumatologie
Cluj-napoca, 400006
RomaniaSite Not Available
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Cape Town, 7925
South AfricaSite Not Available
Chris Hani Baragwanath Hospital; Rheumatology Department
Diepkloof, 1862
South AfricaSite Not Available
Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
Barcelona, 08035
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia
Barcelona, 08025
SpainSite Not Available
Hospital Universitario San Cecilio; Unidad de Enfermedades Autoinmunes Sistemicas
Granada, 18012
SpainSite Not Available
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
Madrid, 28007
SpainSite Not Available
Universitätsspital Basel; Rheumatologische Poliklinik
Basel, 4031
SwitzerlandSite Not Available
Universitätsspital Zürich; Klinik für Rheumatologie
Zürich, 8091
SwitzerlandSite Not Available
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Bath, BA1 1RL
United KingdomSite Not Available
Queen Elizabeth Hospital; Rheumatology Dept.
Birmingham, B15 2TH
United KingdomSite Not Available
Western General Hospital
Edinburgh, EH4 2XU
United KingdomSite Not Available
Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine
Leeds, LS7 4SA
United KingdomSite Not Available
Uni Hospital Aintree; Academic Rheumatology Unit
Liverpool, L9 7AL
United KingdomSite Not Available
Royal Free Hospital; Department of Rheumatology
London, NW3 2QG
United KingdomSite Not Available
Freeman Hospital; Musculoskeletal Unit
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
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Salford, M6 8HD
United KingdomSite Not Available
TriWest Research Associates, LLC
El Cajon, California 92020
United StatesSite Not Available
St. Joseph's Heritage Healthcare
Fullerton, California 92835
United StatesSite Not Available
Arthritis Associates of Southern California
Los Angeles, California 90045
United StatesSite Not Available
Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California 90025
United StatesSite Not Available
St. Joseph's Heritage Healthcare
Orange, California 92868
United StatesSite Not Available
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Palo Alto, California 94304
United StatesSite Not Available
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Redwood City, California 94063
United StatesSite Not Available
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Farmington, Connecticut 06030
United StatesSite Not Available
Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.
Washington, District of Columbia 20007
United StatesSite Not Available
Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.
Washington, D.C., District of Columbia 20007
United StatesSite Not Available
Rheumatology Assoc. of S. Florida - Clinical Research Center
Boca Raton, Florida 33486
United StatesSite Not Available
Millenium Research
Ormond Beach, Florida 32174
United StatesSite Not Available
Arthritis Center Palm Harbor
Palm Harbor, Florida 34684
United StatesSite Not Available
Boston Univ Med Center - AC
Boston, Massachusetts 02118
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109-0934
United StatesSite Not Available
West Michigan Rheumatology, PLLC
Grand Rapids, Michigan 49546
United StatesSite Not Available
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New Brunswick, New Jersey 08903
United StatesSite Not Available
Steffens Scleroderma Center
Albany, New York 12206
United StatesSite Not Available
Joint & Muscle Research Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma 74104
United StatesSite Not Available
Thomas Jefferson Uni ; Division of Rheumatology
Philadelphia, Pennsylvania 19131
United StatesSite Not Available
Clinical Research Center of Reading
Wyomissing, Pennsylvania 19610
United StatesSite Not Available
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Metroplex Clinical Research
Dallas, Texas 75231
United StatesSite Not Available
University of Texas Rheumatology Clinic
Houston, Texas 77030
United StatesSite Not Available
Swedish Research Center
Seattle, Washington 98122
United StatesSite Not Available
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