A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
- Registration Number
- NCT03313180
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
- Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment
- 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.
- Further inclusion criteria apply
-
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
-
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
-
Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nintedanib 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.
- Primary Outcome Measures
Name Time Method Number of Patients With Any Adverse Event (AE) Over the Course of the Trial First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months. Number of patients with any adverse event (AE) over the course of the trial.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (159)
HOP Pasteur
🇫🇷Nice, France
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
🇦🇷Buenos Aires, Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
🇦🇷Florida, Argentina
UZ Leuven
🇧🇪Leuven, Belgium
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Edumed - Educacao e Saude SA
🇧🇷Curitiba, Brazil
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
UNIV UZ Gent
🇧🇪Gent, Belgium
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
🇨🇱Concepción, Chile
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
APRILLUS-Asistencia e Investigación
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
HYKS Keuhkosairauksien tutkimusyksikkö
🇫🇮Helsinki, Finland
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
HOP Bretonneau
🇫🇷Tours, France
HSCM
🇨🇦Montreal, Quebec, Canada
West China Hospital
🇨🇳Chengdu, China
The First Hospital of China Medical University
🇨🇳Shenyang, China
HOP Avicenne
🇫🇷Bobigny, France
Peking Union Medical College Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, China
HOP Louis Pradel
🇫🇷Bron, France
Institute of Rheumathology Prague
🇨🇿Prague, Czechia
HOP Bichat
🇫🇷Paris, France
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, 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
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
CHRU Lille
🇫🇷Lille, France
HOP Claude Huriez
🇫🇷Lille, France
HOP Arnaud de Villeneuve
🇫🇷Montpellier, France
HOP Hôtel-Dieu
🇫🇷Nantes, France
HOP Pontchaillou
🇫🇷Rennes, France
HOP Charles Nicolle
🇫🇷Rouen, France
HOP Larrey
🇫🇷Toulouse, 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
🇩🇪Hannover, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
General Hospital of Athens "Laiko"
🇬🇷Athens, Greece
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Ramaiah Medical College and Hospitals
🇮🇳Bangalore, India
Care Hospital
🇮🇳Hyderabad, India
Sir Gangaram Hospital
🇮🇳Delhi, India
Asthma Bhawan
🇮🇳Jaipur, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, India
Getwell Hospital & Research Institute
🇮🇳Nagpur, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Rambam Medical Center
🇮🇱Haifa, Israel
B.J. Medical College and Sasoon General Hospital
🇮🇳Pune, India
Bnei Zion Medical Center, Haifa
🇮🇱Haifa, Israel
Rabin Medical Center Beilinson
🇮🇱Petah Tiqwa, 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
🇮🇹Padova, Italy
Azienda Universitaria-Universita' La Sapienza
🇮🇹Roma, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Hyogo, Himeji, Japan
Sapporo Medical University Hospital
🇯🇵Hokkaido, Sapporo, 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
Tokushima University Hospital
🇯🇵Tokushima, Tokushima, Japan
Hamamatsu University Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-Ku, Japan
Juntendo University 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
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Pulau Pinang
🇲🇾Georgetown Pulau Pinang, Malaysia
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
🇲🇽Ciudad de México, Mexico
Amsterdam UMC Locatie VUMC
🇳🇱Amsterdam, Netherlands
Leids Universitair Medisch Centrum (LUMC)
🇳🇱Leiden, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Oslo Universitetssykehus HF, Rikshospitalet
🇳🇴Oslo, Norway
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
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
🇵🇱Rzeszow, Poland
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
🇵🇱Wroclaw, Poland
Hospital Garcia de Orta, EPE
🇵🇹Almada, Portugal
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Fernando Fonseca, EPE
🇵🇹Amadora, Portugal
Centro Hospitalar Universitário São João,EPE
🇵🇹Porto, Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
🇵🇹Ponte de Lima, Portugal
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Clinical Rheumatology Research Center Sahlgrenska
🇸🇪Gothenburg, Sweden
University Hospital Zurich
🇨🇭Zürich, Switzerland
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Srinagarind Hospital
🇹🇭Muang, Thailand
Songklanagarind Hospital
🇹🇭Songkhla, Thailand
Royal Free Hospital
🇬🇧London, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom
The First Hospital of Jilin University
🇨🇳Changchun, China
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Froedtert and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
🇺🇸Nashville, Tennessee, United States
TYKS
🇫🇮Turku, Finland
Centro de Investigación del Maule
🇨🇱Talca, Chile
Guy's Hospital
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States