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A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

Primary Purpose

Lung Diseases, Interstitial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California Los Angeles
  • University of California Davis
  • University of California San Francisco
  • Stanford University Medical Center
  • University of Colorado Denver
  • Yale University School of Medicine
  • Georgetown University
  • University of Florida College of Medicine
  • University of Miami
  • The Emory Clinic
  • Northwestern University
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Tulane University Hospital and Clinic
  • Johns Hopkins Hospital
  • Boston University School of Medicine
  • University of Minnesota
  • Mayo Clinic, Rochester
  • Washington University School of Medicine
  • Hospital for Special Surgery
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center-New York Presbyterian Hospital
  • Duke University Medical Center
  • University of Cincinnati
  • Cleveland Clinic
  • University of Toledo
  • University of Pennsylvania
  • Thomas Jefferson University
  • Temple University Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
  • University of Texas Southwestern Medical Center
  • The University of Texas Health Science Center at Houston
  • University of Utah Health Sciences Center
  • Inova Fairfax Medical Campus
  • Virginia Mason Medical Center
  • University of Washington
  • Froedtert and The Medical College of Wisconsin
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • APRILLUS-Asistencia e Investigación
  • CEMER-Centro Medico De Enfermedades Respiratorias
  • Royal Prince Alfred Hospital
  • Liverpool Hospital
  • Royal Adelaide Hospital
  • St Vincent's Hospital Melbourne
  • Medical University of Innsbruck
  • UNIV UZ Gent
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Edumed - Educacao e Saude SA
  • HSCM
  • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
  • Centro de Investigación del Maule
  • Peking Union Medical College Hospital
  • The First Hospital of Jilin University
  • West China Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Huashan Hospital, Fudan University
  • The First Hospital of Chinese Medical University
  • Institute of Rheumathology Prague
  • Aarhus University Hospital
  • Odense University Hospital
  • HYKS Keuhkosairauksien tutkimusyksikkö
  • TYKS
  • HOP Avicenne
  • HOP Louis Pradel
  • CHRU Lille
  • HOP Claude Huriez
  • HOP Arnaud de Villeneuve
  • HOP Hôtel-Dieu
  • HOP Pasteur
  • HOP Bichat
  • HOP Pontchaillou
  • HOP Charles Nicolle
  • HOP Larrey
  • HOP Bretonneau
  • Klinik Donaustauf
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Erlangen
  • Universitätsmedizin Greifswald
  • Asklepios Klinik Altona
  • Medizinische Hochschule Hannover
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Universitätsklinikum Münster
  • Universitätsklinikum Tübingen
  • General Hospital of Athens "Laiko"
  • Ramaiah Medical College and Hospitals
  • Post Graduate Institute of Medical Education and Research
  • Sir Gangaram Hospital
  • Care Hospital
  • Nizam's Institute of Medical Sciences
  • Asthma Bhawan
  • Getwell Hospital & Research Institute
  • All India Institute of Medical Sciences
  • B.J. Medical College and Sasoon General Hospital
  • Bnei Zion Medical Center, Haifa
  • Rambam Medical Center
  • Rabin Medical Center Beilinson
  • Sourasky Medical Center
  • Università degli Studi di Genova
  • A.O. San Gerardo di Monza
  • A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
  • Università degli Studi Padova
  • Azienda Universitaria-Universita' La Sapienza
  • Tosei General Hospital
  • Kurume University Hospital
  • Sapporo Medical University Hospital
  • National Hospital Organization Himeji Medical Center
  • St. Marianna University Hospital
  • Kitasato University Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Nagasaki University Hospital
  • Kindai University Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Osaka Medical College Hospital
  • Saitama Medical University Hospital
  • Hamamatsu University Hospital
  • Tokushima University Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • Toho University Omori Medical Center
  • Institute of Rheumatology Tokyo Women's Medical University
  • Hospital Pulau Pinang
  • University of Malaya Medical Centre
  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
  • Amsterdam UMC Locatie VUMC
  • Leids Universitair Medisch Centrum (LUMC)
  • Radboud Universitair Medisch Centrum
  • Erasmus Medisch Centrum
  • Oslo Universitetssykehus HF, Rikshospitalet
  • Universitetssykehuset Nord-Norge, Tromsø
  • Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
  • Specialist Allergy-Internist Center ALL-MED
  • EMED, Center of Medical Services,Private Prac,Rzeszow
  • Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
  • Hospital Garcia de Orta, EPE
  • Hospital Fernando Fonseca, EPE
  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • ULSAM, EPE - Hospital Conde de Bertiandos
  • Centro Hospitalar Universitário São João,EPE
  • Centro Hospitalar de Vila Nova de Gaia
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebron
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario 12 de Octubre
  • Hospital Dr. Peset
  • Hospital Politècnic La Fe
  • Hospital Álvaro Cunqueiro
  • Clinical Rheumatology Research Center Sahlgrenska
  • University Hospital Zurich
  • Ramathibodi Hospital
  • Srinagarind Hospital
  • Songklanagarind Hospital
  • Royal Free Hospital
  • Guy's Hospital
  • Royal Brompton Hospital
  • Salford Royal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Outcomes

Primary Outcome Measures

Incidence of overall adverse events over the course of this extension trial

Secondary Outcome Measures

Full Information

First Posted
October 13, 2017
Last Updated
February 27, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT03313180
Brief Title
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
Official Title
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Other Intervention Name(s)
OVEF
Intervention Description
Administered twice daily
Primary Outcome Measure Information:
Title
Incidence of overall adverse events over the course of this extension trial
Time Frame
Up to 34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
APRILLUS-Asistencia e Investigación
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
CEMER-Centro Medico De Enfermedades Respiratorias
City
Florida
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Edumed - Educacao e Saude SA
City
Curitiba
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
HSCM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Centro de Investigación del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The First Hospital of Chinese Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Institute of Rheumathology Prague
City
Prague
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
Facility Name
HYKS Keuhkosairauksien tutkimusyksikkö
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
TYKS
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
HOP Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
HOP Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
HOP Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
HOP Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
HOP Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Klinik Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Ramaiah Medical College and Hospitals
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Sir Gangaram Hospital
City
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Care Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Asthma Bhawan
City
Jaipur
ZIP/Postal Code
302039
Country
India
Facility Name
Getwell Hospital & Research Institute
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
B.J. Medical College and Sasoon General Hospital
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Bnei Zion Medical Center, Haifa
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Università degli Studi di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. San Gerardo di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Università degli Studi Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Universitaria-Universita' La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo, Himeji
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kanagawa, Kawasaki
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Osaka, Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Osaka, Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Saitama, Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima, Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-Ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo, Bunkyo-Ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Tokyo, Ota-ku
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Institute of Rheumatology Tokyo Women's Medical University
City
Tokyo, Shinjyuku-ku
ZIP/Postal Code
162-0054
Country
Japan
Facility Name
Hospital Pulau Pinang
City
Georgetown Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
City
Ciudad de México
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Amsterdam UMC Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Oslo Universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge, Tromsø
City
Tromsø
ZIP/Postal Code
N-9038
Country
Norway
Facility Name
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85168
Country
Poland
Facility Name
Specialist Allergy-Internist Center ALL-MED
City
Krakow
ZIP/Postal Code
30033
Country
Poland
Facility Name
EMED, Center of Medical Services,Private Prac,Rzeszow
City
Rzeszow
ZIP/Postal Code
35205
Country
Poland
Facility Name
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Hospital Garcia de Orta, EPE
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospital Fernando Fonseca, EPE
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
ULSAM, EPE - Hospital Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Centro Hospitalar Universitário São João,EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Clinical Rheumatology Research Center Sahlgrenska
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

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