A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

November 12, 2015

Primary Completion Date

October 31, 2018

Study Completion Date

November 28, 2018

Conditions
Scleroderma, Systemic
Interventions
DRUG

Nintedanib

DRUG

Placebo

Trial Locations (195)

1070

ULB Hopital Erasme, Brussels

1125

Semmelweis University, Dept. Pulmonology, Budapest

1200

Brussels - UNIV Saint-Luc, Brussels

2050

Royal Prince Alfred Hospital, Camperdown

2170

Liverpool Hospital, Sydney

3000

UZ Leuven, Leuven

3065

St Vincent's Hospital Melbourne, Fitzroy

4000

Centre Hospitalier Universitaire de Liège, Liège

5000

Royal Adelaide Hospital, Adelaide

6020

Medical University of Innsbruck, Innsbruck

8000

Aarhus Universitets Hospital, Aarhus

8036

LKH-Univ. Hospital Graz, Graz

8091

Universitätsspital Zürich, Zurich

9000

UNIV UZ Gent, Ghent

9007

Kantonspital St. Gallen, Rheumatologie Department, Sankt Gallen

10021

Hospital for Special Surgery, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center-New York Presbyterian Hospital, New York

10400

Ramathibodi Hospital, Ratchathewi

10990

Hospital Pulau Pinang, Pulau Pinang

11527

"General Hospital of Athens Laiko", Athens

12850

Institute of Rheumathology Prague, Prague

14059

Thomayer Hospital, Prague

14080

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City

16132

Università degli Studi di Genova, Genova

17033

Penn State Milton S. Hershey Medical Center, Hershey

17475

Universitätsmedizin Greifswald, Greifswald

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19140

Temple University Hospital, Philadelphia

20007

Georgetown University, Washington D.C.

20520

TYKS, Keuhkosairauksien klinikka, Turku, Turku

20900

A.O. San Gerardo di Monza, Monza

21224

Johns Hopkins Hospital, Baltimore

22042

Inova Fairfax Medical Campus, Falls Church

22763

Asklepios Klinik Altona, Hamburg

24105

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

27710

Duke University Medical Center, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29203

University of South Carolina, Columbia

29425

Medical University of South Carolina, Charleston

30322

The Emory Clinic, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31011

Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow, Krakow

31048

Bnei Zion Medical Center, Haifa, Haifa

31059

HOP Larrey, Toulouse

32209

University of Florida College of Medicine, Jacksonville

33125

University of Miami, Miami

34295

HOP Arnaud de Villeneuve, Montpellier

35033

HOP Pontchaillou, Rennes

35128

Università degli Studi Padova, Padua

35205

EMED, Center of Medical Services,Private Prac,Rzeszow, Rzeszów

35294

University of Alabama at Birmingham, Birmingham

36312

Hospital Álvaro Cunqueiro, Vigo

37044

HOP Bretonneau, Tours

39008

Hospital Universitario Marqués de Valdecilla, Santander

40002

Srinagarind Hospital, Muang

40202

University of Louisville, Louisville

43614

University of Toledo, Toledo

44000

HOP Hôtel-Dieu, Nantes

44195

Cleveland Clinic, Cleveland

45219

University of Cincinnati Health, Cincinnati

46017

Hospital Dr. Peset, Valencia

46026

Hospital Politècnic La Fe, Valencia

48109

University of Michigan Health System, Ann Arbor

48149

Universitätsklinikum Münster, Münster

49100

Rabin Medical Center Beilinson, Petah Tikva

50937

Universitätsklinikum Köln (AöR), Cologne

52242

University of Iowa, Iowa City

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

55455

University of Minnesota Masonic Cancer Center, Minneapolis

55905

Mayo Clinic-Rochester, Rochester

59037

HOP Calmette, Lille

HOP Claude Huriez, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

60126

Az. Ospedaliere Umberto I di Ancona, Ancona

60611

Northwestern University, Chicago

61231

Kerckhoff-Klinik, Bad Nauheim, Bad Nauheim

63017

The Lung Research Center, LLC, Chesterfield

63110

Washington University School of Medicine, St Louis

64239

Sourasky Medical Center, Tel Aviv

66160

University of Kansas Medical Center, Kansas City

68100

Hospital Selayang, Kuala Selangor

69126

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg, Heidelberg

69677

HOP Louis Pradel, Bron

70112

Tulane University Hospital and Clinic, New Orleans

70300

Hospital Tuanku Ja'afar, Seremban

72076

Universitätsklinikum Tübingen, Tübingen

75014

HOP Cochin, Paris

75018

HOP Bichat, Paris

75390

University of Texas Southwestern Medical Center, Dallas

76000

HOP Charles Nicolle, Rouen

77030

The University Of Texas at Houston, Houston

80045

University of Colorado Denver, Aurora

80138

A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli, Napoli

80336

Klinikum der Universität München - Campus Großhadern, München

84108

University of Utah Health Sciences Center, Salt Lake City

85168

Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz, Bydgoszcz

90095

University of California Los Angeles, Los Angeles

90110

Songklanagarind Hospital, Hat Yai

91054

Universitätsklinikum Erlangen, Erlangen

93009

HOP Avicenne, Bobigny

93093

Klinik Donaustauf, Donaustauf

94143

University of California San Francisco, San Francisco

95817

University of California Davis, Sacramento

98101

Virginia Mason Medical Center, Seattle

98195

University of Washington, Seattle

100032

Peking Union Medical College Hospital, Beijing

110029

All India Institute of Medical Science, New Delhi

110060

Sir Gangaram Hospital, New Delhi

160012

Postgraduate Institute of Medical Education And Research, Chandigarh

200040

Huashan Hospital, Fudan University, Shanghai

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

302039

Asthma Bhawan, Jaipur

400016

P.D. Hinduja National Hospital, Mumbai

411001

B.J. Medical College and Sasoon General Hospital, Pune

411040

Inamdar Multispeciality Hospital, Pune

412007

Zhuzhou Central Hospital, Zhuzhou

440012

Getwell Hospital & Research Institute, Nagpur

500034

Care Hospital, Hyderabad

500082

Nizam's Institute of Medical Sciences, Hyderabad

560054

Ramaiah Medical College and Hospitals, Bangalore

560099

Mazumdar Shaw Medical centre, Bangalore

610041

West China Hospital, Chengdu

3109601

Rambam Medical Center, Haifa

3465586

Centro de Investigación del Maule, Talca

4070038

"Hospital Clínico Reg. de Concepción Dr. G. Grant Benavente", Concepción

94305-5236

Stanford University Medical Center, Stanford

06510

Yale University School of Medicine, New Haven

02118

Boston Medical Center, Boston

37232-5735

Vanderbilt Pulmonary Clinic, Nashville

C1426BOR

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Buenos Aires

C1046AAQ

APRILLUS-Asistencia e Investigación, Ciudad Autonoma Buenos Aires

B1602DQD

CEMER-Centro Medico De Enfermedades Respiratorias, Florida

80440-080

Edumed - Educacao e Saude SA, Curitiba

L8N 4A6

Saint Joseph's Healthcare, Hamilton

M5T 3L9

Mount Sinai Hospital, Toronto

H4J 1C5

HSCM, Montreal

Unknown

Beijing Chao-Yang Hospital, Beijing

Beijing Hospital, Beijing

First Hospital of Jilin University, Changchun

The First Hospital of Chinese Medical University, Shenyang

Cork University Hospital, Cork

Mater Misericordiae University Hospital, Dublin

5000 C

Odense Universitetshospital, Odense

00290

HYKS Keuhkosairauksien, Helsinki

06001

HOP Pasteur, Nice

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

115 27

"General Hospital of Athens Laiko", Athens

560 034

St John's Medical College, Bangalore

411 001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

632 004

Christian Medical College, Vellore

00161

Azienda Universitaria-Universita' La Sapienza, Roma

489-8642

Tosei General Hospital, Aichi, Seto

830-0011

Kurume University Hospital, Fukuoka, Kurume

060-8543

Sapporo Medical University Hospital, Hokkaido, Sapporo

670-8520

National Hospital Organization Himeji Medical Center, Hyogo, Himeji

020-8505

Iwate Medical University Hospital, Iwate, Morioka

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa, Kawasaki

252-0375

Kitasato University Hospital, Kanagawa, Sagamihara

236-0051

Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Yokohama

606-8507

Kyoto University Hospital, Kyoto, Kyoto

852-8501

Nagasaki University Hospital, Nagasaki, Nagasaki

589-8511

Kindai University Hospital, Osaka, Osakasayama

591-8555

National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Sakai

569-8686

Osaka Medical College Hospital, Osaka, Takatsuki

350-0495

Saitama Medical University Hospital, Saitama, Iruma-gun

431-3192

Hamamatsu University Hospital, Shizuoka, Hamamatsu

770-8503

Tokushima University Hospital, Tokushima, Tokushima

113-8431

Juntendo University Hospital, Tokyo, Bunkyo-Ku

113-8603

Nippon Medical School Hospital, Tokyo, Bunkyo-Ku

143-8541

Toho University Omori Medical Center, Tokyo, Ota-ku

162-0054

Institute of Rheumatology Tokyo Women's Medical University, Tokyo, Shinjyuku-ku

1081HV

VU Medisch Centrum, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum (LUMC), Leiden

6525 GA

Radboud Universitair Medisch Centrum, Nijmegen

3015 CE

Erasmus Medisch Centrum, Rotterdam

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

N-9038

Universitetssykehuset Nord-Norge, Tromsø, Tromsø

50 368

Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw, Wroclaw

2801-951

Hospital Garcia de Orta, EPE, Almada

2720-276

Hospital Fernando Fonseca, EPE, Amadora

3000-075

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra

4990-041

ULSAM, EPE - Hospital Conde de Bertiandos, Ponte de Lima

4200-319

Centro Hospitalar São João,EPE, Porto

4434-502

Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia

08035

Hospital Vall d'Hebron, Barcelona

08041

Hospital Santa Creu i Sant Pau, Barcelona

413 45

Clinical Rheumatology Research Center Sahlgrenska, Gothenburg

G4 0SF

Glasgow Royal Infirmary, Glasgow

NW3 2QG

Royal Free Hospital, London

SE1 9RT

Guy's Hospital, London

SW3 6NP

Royal Brompton Hospital, London

M6 8HD

Salford Royal Hospital, Salford

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY