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Trial record 1 of 1 for:    1199.214
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A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

This study is currently recruiting participants.
Verified November 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02597933
First Posted: November 5, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

Condition Intervention Phase
Scleroderma, Systemic Drug: Nintedanib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Annual rate of decline in FVC in mL [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Time to all-cause mortality [ Time Frame: 52 weeks ]
  • Absolute change from baseline in FACIT dyspnoea score [ Time Frame: 52 weeks ]
  • Absolute change from baseline in the mRSS [ Time Frame: 52 weeks ]
  • Absolute change from baseline in SGRQ total score [ Time Frame: 52 weeks ]
  • Annual rate of decline in FVC in percent predicted [ Time Frame: 52 weeks ]
  • Absolute change from baseline in FVC in mL [ Time Frame: 52 weeks ]
  • Relative change from baseline (%) of mRSS [ Time Frame: 52 weeks ]
  • Absolute change from baseline in DLCO in percent predicted [ Time Frame: 52 weeks ]
  • Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) [ Time Frame: 52 weeks ]
  • Absolute change from baseline in SHAQ total score [ Time Frame: 52 weeks ]

Estimated Enrollment: 520
Actual Study Start Date: November 12, 2015
Estimated Study Completion Date: December 28, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nintedanib
patient receives capsules containing nintedanib twice a day
Drug: Nintedanib
Placebo Comparator: Placebo
patient receives capsules identical to those containing active drug
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age >= 18 years
  • 2013 ACR / EULAR classification criteria for SSc fulfilled
  • SSc disease onset (defined by first non-Raynaud symptom) within 7 years
  • SSc related Interstitial Lung Disease confirmed by HRCT; Extent of fibrotic disease in the lung >= 10%
  • FVC >= 40% of predicted normal
  • DLCO 30% to 89% of predicted normal

Exclusion criteria:

  • AST, ALT >1.5 x ULN
  • Bilirubin >1.5 x ULN
  • Creatinine clearance <30 mL/min
  • Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant PH
  • Cardiovascular diseases
  • More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
  • Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
  • international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
  • History of thrombotic event within last year
  • Clinical signs of malabsorption or needing parenteral nutrition
  • Previous treatment with nintedanib or pirfenidone
  • Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate
  • Unstable background therapy with either mycophenolate mofetil or methotrexate
  • Previous or planned hematopoietic stem cell transplantation
  • Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597933


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, California
University of California Recruiting
Los Angeles, California, United States, 90095
University of California Recruiting
Sacramento, California, United States, 95817
University of California Recruiting
San Francisco, California, United States, 94143
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305-5236
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
University of Florida College of Medicine Recruiting
Jacksonville, Florida, United States, 32209
University of Miami Recruiting
Miami, Florida, United States, 33125
United States, Georgia
The Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Univeristy of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Hospital and Clinic Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Scleroderma Center Recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic-Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
The Lung Research Center, LLC Recruiting
Chesterfield, Missouri, United States, 63017
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center-New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Health Recruiting
Cincinnati, Ohio, United States, 45219
Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
The Univ of PA Perelman Ctr for Advncd Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
Vanderbilt Pulmonary Clinic Recruiting
Nashville, Tennessee, United States, 37232-5735
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8558
The University Of Texas at Houston Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84108
United States, Virginia
Inova Fairfax Medical Campus Recruiting
Falls Church, Virginia, United States, 22042
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
University of Washington Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Militar Central Recruiting
Buenos Aires, Argentina, C1426BOR
Centro de Investigaciones Metabólicas (CINME) Recruiting
C.a.b.a, Argentina, 1056
APRILLUS Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
CEMER-Centro Medico De Enfermedades Respiratorias Recruiting
Florida, Argentina, B1602DQD
Australia, New South Wales
Royal Prince Alfred Hospital, Respiratory Dept Recruiting
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital Recruiting
Sydney, New South Wales, Australia, 2170
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
St Vincents Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Belgium
Brussels - UNIV Erasme Recruiting
Bruxelles, Belgium, 1070
Brussels - UNIV St-Luc Recruiting
Bruxelles, Belgium, 1200
UNIV UZ Gent Recruiting
Gent, Belgium, 9000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Brazil
Edumed - Educacao e Saude SA Recruiting
Curitiba, Brazil, 80440-080
Canada, Ontario
Saint Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
HSCM Recruiting
Montreal, Quebec, Canada, H4J 1C5
Chile
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente" Recruiting
Concepción, Chile, 4070038
Centro de Investigación del Maule Recruiting
Talca, Chile, 3465586
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Beijing Chao-Yang Hospital Recruiting
Beijing, China
Beijing Hospital Recruiting
Beijing, China
First Hospital of Jilin University Recruiting
Changchun, China
West China Hospital Recruiting
Chengdu, China, 610041
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, China, 230022
Huashan Hospital, Fudan University Recruiting
Shanghai, China, 200040
The First Hospital of Chinese Medical University Recruiting
Shenyang, China
Zhuzhou Central Hospital Recruiting
Zhuzhou, China, 412007
Czechia
Institute of Rheumathology Prague Recruiting
Prague, Czechia, 12850
Thomayer Hospital Recruiting
Praha 4, Czechia, 14059
Denmark
Odense Universitetshospital Recruiting
Odense, Denmark, 5000 C
Aarhus Universitetshospital Recruiting
Århus, Denmark, 8000
Finland
HYKS Keuhkosairauksien Recruiting
Helsinki, Finland, 00290
TYKS, Keuhkosairauksien klinikka, Turku Recruiting
Turku, Finland, 20520
France
HOP Avicenne Recruiting
Bobigny, France, 93009
HOP de la Cavale Blanche Recruiting
Brest, France, 29609
HOP Louis Pradel Active, not recruiting
Bron, France, 69677
HOP Claude Huriez Recruiting
Lille cedex, France, 59037
HOP Calmette Recruiting
Lille, France, 59037
HOP Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
HOP Hôtel-Dieu Recruiting
Nantes, France, 44000
HOP Pasteur Active, not recruiting
Nice, France, 06001
HOP Cochin Active, not recruiting
Paris, France, 75014
HOP Bichat Recruiting
Paris, France, 75018
HOP Cochin Recruiting
Paris, France, 75679
HOP Pontchaillou Recruiting
Rennes, France, 35033
HOP Charles Nicolle Active, not recruiting
Rouen cedex, France, 76000
HOP Larrey Active, not recruiting
Toulouse, France, 31059
HOP Bretonneau Recruiting
Tours, France, 37044
Germany
Kerckhoff-Klinik, Bad Nauheim Recruiting
Bad Nauheim, Germany, 61231
Krankenhaus, Donaustauf Recruiting
Donaustauf, Germany, 93093
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany, 17475
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Universitätsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Universitätsklinikum Köln (AöR) Recruiting
Köln, Germany, 50937
Klinikum der Universität München - Campus Großhadern Recruiting
München, Germany, 80336
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Greece
General Hospital of Athens "Laiko" Recruiting
Athens, Greece, 115 27
General Hospital of Athens "Laiko" Recruiting
Athens, Greece, 11527
Hungary
Semmelweis University, Dept. Pulmonology Recruiting
Budapest, Hungary, 1125
India
Sanjivani Superspeciality Hospital Pvt. Ltd. Recruiting
Ahmedabad, India, 380015
St John's Medical College Recruiting
Bangalore, India, 560 034
Ramaiah Medical College and Hospitals Recruiting
Bangalore, India, 560054
Mazumdar Shaw Medical centre Recruiting
Bangalore, India, 560099
Postgraduate Institute of Medical Education And Research Recruiting
Chandigarh, India, 160012
Care Hospital Recruiting
Hyderabad, India, 500034
Nizam's Institute of Medical Sciences Recruiting
Hyderabad, India, 500082
Fortis Hospital Recruiting
Kolkata, India
P.D. Hinduja National Hospital Recruiting
Mumbai, India, 400016
Getwell Hospital & Research Institute Recruiting
Nagpur, India, 440012
All India Institute of Medical Science Recruiting
New Delhi, India, 110029
Sir Gangaram Hospital Recruiting
New Delhi, India, 110060
Jehangir Clinical Development Centre Pvt. Ltd. Active, not recruiting
Pune, India, 411 001
B.J. Medical College and Sasoon General Hospital Recruiting
Pune, India, 411001
Inamdar Multispeciality Hospital Recruiting
Pune, India, 411040
Christian Medical College Recruiting
Vellore, India, 632 004
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Mater Misericordiae University Hospital Recruiting
Dublin 7, Ireland
Israel
Bnei Zion Medical Center, Haifa Recruiting
Haifa, Israel, 31048
Rambam Medical Center Recruiting
Haifa, Israel, 3109601
Rabin Medical Center Beilinson Recruiting
Petah Tiqwa, Israel, 49100
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Italy
Az. Ospedaliere Umberto I di Ancona Recruiting
Ancona, Italy, 60126
Università degli Studi di Genova Recruiting
Genova, Italy, 16132
A.O. San Gerardo di Monza Recruiting
Monza, Italy, 20900
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli Recruiting
Napoli, Italy, 80138
Università degli Studi Padova Recruiting
Padova, Italy, 35128
Azienda Universitaria-Universita' La Sapienza Recruiting
Roma, Italy, 00161
Japan
Tosei General Hospital Recruiting
Aichi, Seto, Japan, 489-8642
Kurume University Hospital Recruiting
Fukuoka, Kurume, Japan, 830-0011
Sapporo Medical University Hospital Recruiting
Hokkaido, Sapporo, Japan, 060-8543
National Hospital Organization Himeji Medical Center Recruiting
Hyogo, Himeji, Japan, 670-8520
Iwate Medical University Hospital Recruiting
Iwate, Morioka, Japan, 020-8505
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Kawasaki, Japan, 216-8511
Kitasato University Hospital Recruiting
Kanagawa, Sagamihara, Japan, 252-0375
Kanagawa Cardiovascular and Respiratory Center Recruiting
Kanagawa, Yokohama, Japan, 236-0051
Kyoto University Hospital Recruiting
Kyoto, Kyoto, Japan, 606-8507
Nagasaki University Hospital Recruiting
Nagasaki, Nagasaki, Japan, 852-8501
Kindai University Hospital Recruiting
Osaka, Osakasayama, Japan, 589-8511
National Hospital Organization Kinki-Chuo Chest Medical Center Recruiting
Osaka, Sakai, Japan, 591-8555
Osaka Medical College Hospital Recruiting
Osaka, Takatsuki, Japan, 569-8686
Saitama Medical University Hospital Recruiting
Saitama, Iruma-gun, Japan, 350-0495
Hamamatsu University Hospital Recruiting
Shizuoka, Hamamatsu, Japan, 431-3192
Tokushima University Hospital Recruiting
Tokushima, Tokushima, Japan, 770-8503
Juntendo University Hospital Recruiting
Tokyo, Bunkyo-Ku, Japan, 113-8431
Nippon Medical School Hospital Recruiting
Tokyo, Bunkyo-Ku, Japan, 113-8603
Toho University Omori Medical Center Recruiting
Tokyo, Ota-ku, Japan, 143-8541
Institute of Rheumatology Tokyo Women's Medical University Recruiting
Tokyo, Shinjyuku-ku, Japan, 162-0054
Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas Recruiting
Ciudad de México, Mexico, 14080
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081HV
Leids Universitair Medisch Centrum (LUMC) Recruiting
Leiden, Netherlands, 2333 ZA
Radboud Universitair Medisch Centrum Recruiting
Nijmegen, Netherlands, 6525 GA
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
Norway
Oslo Universitetssykehus HF, Rikshospitalet Active, not recruiting
Oslo, Norway, N-0424
Universitetssykehuset Nord-Norge, Tromsø Active, not recruiting
Tromsø, Norway, N-9038
Poland
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz Recruiting
Bydgoszcz, Poland, 85168
Specialist Center ALL-MED, Krakow Recruiting
Krakow, Poland, 31-023
Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow Terminated
Krakow, Poland, 31011
Reumed, Private Practice, Lublin Recruiting
Lublin, Poland, 02607
Indep.Pblic Clin.Hosp#Lublin,Dermat,Venereol.&Pediatric Dept Recruiting
Lublin, Poland, 20080
EMED, Center of Medical Services,Private Prac,Rzeszow Recruiting
Rzeszow, Poland, 35205
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw Recruiting
Wroclaw, Poland, 50 368
Portugal
Hospital Garcia de Orta, EPE Active, not recruiting
Almada, Portugal, 2801-951
Hospital Fernando Fonseca, EPE Active, not recruiting
Amadora, Portugal, 2720-276
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Active, not recruiting
Coimbra, Portugal, 3000-075
ULSAM, EPE - Hospital Conde de Bertiandos Active, not recruiting
Ponte de Lima, Portugal, 4990-041
Centro Hospitalar São João,EPE Active, not recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Vila Nova de Gaia Active, not recruiting
Vila Nova de Gaia, Portugal, 4434-502
Spain
Hospital Vall d'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital Santa Creu i Sant Pau Active, not recruiting
Barcelona, Spain, 08041
Hospital General Universitario Gregorio Marañón Active, not recruiting
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario Marqués de Valdecilla Active, not recruiting
Santander, Spain, 39008
Hospital Dr. Peset Active, not recruiting
Valencia, Spain, 46017
Hospital Politècnic La Fe Active, not recruiting
Valencia, Spain, 46026
Hospital Álvaro Cunqueiro Active, not recruiting
Vigo, Spain, 36312
Sweden
Clinical Rheumatology Research Center Sahlgrenska Recruiting
Gothenburg, Sweden, 413 45
Switzerland
Kantonspital St. Gallen, Rheumatologie Department Recruiting
St. Gallen, Switzerland, 9007
Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8091
United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G4 0SF
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Salford Royal Hospital Recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02597933     History of Changes
Other Study ID Numbers: 1199.214
2015-000392-28 ( EudraCT Number )
First Submitted: October 8, 2015
First Posted: November 5, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action