A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
2 other identifiers
interventional
444
29 countries
158
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2017
Longer than P75 for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedStudy Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedResults Posted
Study results publicly available
February 20, 2024
CompletedFebruary 20, 2024
January 1, 2024
5.2 years
October 13, 2017
January 24, 2024
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial
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.
Study Arms (1)
Nintedanib
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (159)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California Davis
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
University of Miami
Miami, Florida, 33125, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Toledo
Toledo, Ohio, 43614, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
Nashville, Tennessee, 37204, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Washington
Seattle, Washington, 98195, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, C1426BOR, Argentina
APRILLUS-Asistencia e Investigación
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, B1602DQD, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Medical University of Innsbruck
Innsbruck, A-6020, Austria
UNIV UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Edumed - Educacao e Saude SA
Curitiba, 80440-080, Brazil
HSCM
Montreal, Quebec, H4J 1C5, Canada
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, 4070038, Chile
Centro de Investigación del Maule
Talca, 3465586, Chile
Peking Union Medical College Hospital
Beijing, 100032, China
The First Hospital of Jilin University
Changchun, 130021, China
West China Hospital
Chengdu, 610041, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
The First Hospital of China Medical University
Shenyang, 110001, China
Institute of Rheumathology Prague
Prague, 12850, Czechia
Aarhus University Hospital
Aarhus N, 8200, Denmark
Odense University Hospital
Odense, 5000 C, Denmark
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00290, Finland
TYKS
Turku, 20521, Finland
HOP Avicenne
Bobigny, 93009, France
HOP Louis Pradel
Bron, 69677, France
CHRU Lille
Lille, 59037, France
HOP Claude Huriez
Lille, 59037, France
HOP Arnaud de Villeneuve
Montpellier, 34295, France
HOP Hôtel-Dieu
Nantes, 44093, France
HOP Pasteur
Nice, 06001, France
HOP Bichat
Paris, 75877, France
HOP Pontchaillou
Rennes, 35033, France
HOP Charles Nicolle
Rouen, 76000, France
HOP Larrey
Toulouse, 31059, France
HOP Bretonneau
Tours, 37044, France
Klinik Donaustauf
Donaustauf, 93093, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
General Hospital of Athens "Laiko"
Athens, 11527, Greece
Ramaiah Medical College and Hospitals
Bangalore, 560054, India
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
Sir Gangaram Hospital
Delhi, 110060, India
Care Hospital
Hyderabad, 500034, India
Nizam's Institute of Medical Sciences
Hyderabad, 500082, India
Asthma Bhawan
Jaipur, 302039, India
Getwell Hospital & Research Institute
Nagpur, 440012, India
All India Institute of Medical Sciences
New Delhi, 110029, India
B.J. Medical College and Sasoon General Hospital
Pune, 411001, India
Bnei Zion Medical Center, Haifa
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Rabin Medical Center Beilinson
Petah Tikva, 49100, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
Università degli Studi di Genova
Genova, 16132, Italy
A.O. San Gerardo di Monza
Monza, 20900, Italy
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80138, Italy
Università degli Studi Padova
Padua, 35128, Italy
Azienda Universitaria-Universita' La Sapienza
Roma, 00161, Italy
Tosei General Hospital
Aichi, Seto, 489-8642, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543, Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511, Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Kindai University Hospital
Osaka, Osakasayama, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Osaka Medical College Hospital
Osaka, Takatsuki, 569-8686, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Juntendo University Hospital
Tokyo, Bunkyo-Ku, 113-8431, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-Ku, 113-8603, Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541, Japan
Institute of Rheumatology Tokyo Women's Medical University
Tokyo, Shinjyuku-ku, 162-0054, Japan
Hospital Pulau Pinang
Georgetown Pulau Pinang, 10990, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Mexico City, 14080, Mexico
Amsterdam UMC Locatie VUMC
Amsterdam, 1081HV, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0372, Norway
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, N-9038, Norway
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
Bydgoszcz, 85168, Poland
Specialist Allergy-Internist Center ALL-MED
Krakow, 30033, Poland
EMED, Center of Medical Services,Private Prac,Rzeszow
Rzeszów, 35205, Poland
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
Wroclaw, 50-368, Poland
Hospital Garcia de Orta, EPE
Almada, 2801-951, Portugal
Hospital Fernando Fonseca, EPE
Amadora, 2720-276, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, 4990-041, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4434-502, Portugal
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Hospital Politècnic La Fe
Valencia, 46026, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
Clinical Rheumatology Research Center Sahlgrenska
Gothenburg, 413 45, Sweden
University Hospital Zurich
Zurich, 8091, Switzerland
Ramathibodi Hospital
Bangkok, 10400, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 37294870DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 18, 2017
Study Start
November 27, 2017
Primary Completion
January 25, 2023
Study Completion
January 25, 2023
Last Updated
February 20, 2024
Results First Posted
February 20, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.