A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
NCT ID: NCT03313180
Last Updated: 2024-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2017-11-27
2023-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nintedanib
Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.
Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.
Nintedanib
Administered twice daily
Interventions
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Nintedanib
Administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.
Exclusion Criteria
* Bilirubin \> 2 x ULN
* Creatinine clearance \<30 mL/min calculated by Cockcroft-Gault formula.
* Clinically relevant anaemia at investigators discretion.
* Bleeding risk, any of the following
* Known genetic predisposition to bleeding according to the judgement of the investigator
* Patients who require
* Fibrinolysis, full-dose therapeutic anticoagulation
* High dose antiplatelet therapy.
* Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340
* Any of the following after last treatment of 1199.214/1199-0340:
* Haemoptysis or haematuria
* Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers
* Gastric antral vascular ectasia (GAVE)
* Major injury or surgery
* Coagulation parameters: International normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN at Visit 1.
* New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:
* Stroke;
* Deep vein thrombosis;
* Pulmonary embolism;
* Myocardial infarction.
* Major surgery performed within the next 3 months
* Time period \> 12 weeks between last drug intake in 1199.214 or \> 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial
* Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
* A disease or condition which may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient's ability to participate in this trial
* Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
* Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Previous enrolment in this trial
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hospital for Special Surgery
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, , Argentina
APRILLUS-Asistencia e Investigación
Ciudad Autonoma Buenos Aires, , Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Medical University of Innsbruck
Innsbruck, , Austria
UNIV UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Edumed - Educacao e Saude SA
Curitiba, , Brazil
HSCM
Montreal, Quebec, Canada
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, , Chile
Centro de Investigación del Maule
Talca, , Chile
Peking Union Medical College Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital
Chengdu, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Huashan Hospital, Fudan University
Shanghai, , China
The First Hospital of China Medical University
Shenyang, , China
Institute of Rheumathology Prague
Prague, , Czechia
Aarhus University Hospital
Aarhus N, , Denmark
Odense University Hospital
Odense, , Denmark
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , Finland
TYKS
Turku, , Finland
HOP Avicenne
Bobigny, , France
HOP Louis Pradel
Bron, , France
CHRU Lille
Lille, , France
HOP Claude Huriez
Lille, , France
HOP Arnaud de Villeneuve
Montpellier, , France
HOP Hôtel-Dieu
Nantes, , France
HOP Pasteur
Nice, , France
HOP Bichat
Paris, , France
HOP Pontchaillou
Rennes, , France
HOP Charles Nicolle
Rouen, , France
HOP Larrey
Toulouse, , France
HOP Bretonneau
Tours, , France
Klinik Donaustauf
Donaustauf, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
General Hospital of Athens "Laiko"
Athens, , Greece
Ramaiah Medical College and Hospitals
Bangalore, , India
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Sir Gangaram Hospital
Delhi, , India
Care Hospital
Hyderabad, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
Asthma Bhawan
Jaipur, , India
Getwell Hospital & Research Institute
Nagpur, , India
All India Institute of Medical Sciences
New Delhi, , India
B.J. Medical College and Sasoon General Hospital
Pune, , India
Bnei Zion Medical Center, Haifa
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Università degli Studi di Genova
Genova, , Italy
A.O. San Gerardo di Monza
Monza, , Italy
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Università degli Studi Padova
Padua, , Italy
Azienda Universitaria-Universita' La Sapienza
Roma, , Italy
Tosei General Hospital
Aichi, Seto, , Japan
Kurume University Hospital
Fukuoka, Kurume, , Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, , Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, , Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, , Japan
Kitasato University Hospital
Kanagawa, Sagamihara, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, , Japan
Kindai University Hospital
Osaka, Osakasayama, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, , Japan
Osaka Medical College Hospital
Osaka, Takatsuki, , Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, , Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , Japan
Tokushima University Hospital
Tokushima, Tokushima, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-Ku, , Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-Ku, , Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, , Japan
Institute of Rheumatology Tokyo Women's Medical University
Tokyo, Shinjyuku-ku, , Japan
Hospital Pulau Pinang
Georgetown Pulau Pinang, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Mexico City, , Mexico
Amsterdam UMC Locatie VUMC
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, , Norway
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
Bydgoszcz, , Poland
Specialist Allergy-Internist Center ALL-MED
Krakow, , Poland
EMED, Center of Medical Services,Private Prac,Rzeszow
Rzeszów, , Poland
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
Wroclaw, , Poland
Hospital Garcia de Orta, EPE
Almada, , Portugal
Hospital Fernando Fonseca, EPE
Amadora, , Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, , Portugal
Centro Hospitalar Universitário São João,EPE
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Dr. Peset
Valencia, , Spain
Hospital Politècnic La Fe
Valencia, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Clinical Rheumatology Research Center Sahlgrenska
Gothenburg, , Sweden
University Hospital Zurich
Zurich, , Switzerland
Ramathibodi Hospital
Bangkok, , Thailand
Srinagarind Hospital
Muang, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Royal Free Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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References
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Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold AM, Kuwana M, Merkel PA, Stock C, Sambevski S, Denton CP; SENSCIS Trial Investigators. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology (Oxford). 2024 Mar 1;63(3):639-647. doi: 10.1093/rheumatology/kead280.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2016-003403-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199-0225
Identifier Type: -
Identifier Source: org_study_id
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