Clincosm LogoSign in Get a demo

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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03313180
Collaborator
(none)
444
Enrollment
159
Locations
1
Arm
61.1
Anticipated Duration (Months)
2.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
444 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 27, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: All patients

Drug: Nintedanib
Administered twice daily
Other Names:
  • OVEF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of overall adverse events over the course of this extension trial [Up to 34 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 University of California Los Angeles Los Angeles California United States 90095
    3 University of California Davis Sacramento California United States 95817
    4 University of California San Francisco San Francisco California United States 94143
    5 Stanford University Medical Center Stanford California United States 94305
    6 University of Colorado Denver Aurora Colorado United States 80045
    7 Yale University School of Medicine New Haven Connecticut United States 06510
    8 Georgetown University Washington District of Columbia United States 20007
    9 University of Florida College of Medicine Jacksonville Florida United States 32209
    10 University of Miami Miami Florida United States 33125
    11 The Emory Clinic Atlanta Georgia United States 30322
    12 Northwestern University Chicago Illinois United States 60611
    13 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    14 University of Kansas Medical Center Kansas City Kansas United States 66160
    15 Tulane University Hospital and Clinic New Orleans Louisiana United States 70112
    16 Johns Hopkins Hospital Baltimore Maryland United States 21224
    17 Boston University School of Medicine Boston Massachusetts United States 02118
    18 University of Minnesota Minneapolis Minnesota United States 55455
    19 Mayo Clinic, Rochester Rochester Minnesota United States 55905
    20 Washington University School of Medicine Saint Louis Missouri United States 63110
    21 Hospital for Special Surgery New York New York United States 10021
    22 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    23 Columbia University Medical Center-New York Presbyterian Hospital New York New York United States 10032
    24 Duke University Medical Center Durham North Carolina United States 27710
    25 University of Cincinnati Cincinnati Ohio United States 45219
    26 Cleveland Clinic Cleveland Ohio United States 44195
    27 University of Toledo Toledo Ohio United States 43614
    28 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    29 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    30 Temple University Hospital Philadelphia Pennsylvania United States 19140
    31 Medical University of South Carolina Charleston South Carolina United States 29425
    32 Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks Nashville Tennessee United States 37204
    33 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    34 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    35 University of Utah Health Sciences Center Salt Lake City Utah United States 84108
    36 Inova Fairfax Medical Campus Falls Church Virginia United States 22042
    37 Virginia Mason Medical Center Seattle Washington United States 98101
    38 University of Washington Seattle Washington United States 98195
    39 Froedtert and The Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    40 Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Buenos Aires Argentina C1426BOR
    41 APRILLUS-Asistencia e Investigación Ciudad Autonoma Buenos Aires Argentina C1046AAQ
    42 CEMER-Centro Medico De Enfermedades Respiratorias Florida Argentina B1602DQD
    43 Royal Prince Alfred Hospital Camperdown New South Wales Australia 2050
    44 Liverpool Hospital Sydney New South Wales Australia 2170
    45 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    46 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
    47 Medical University of Innsbruck Innsbruck Austria A-6020
    48 UNIV UZ Gent Gent Belgium 9000
    49 UZ Leuven Leuven Belgium 3000
    50 Centre Hospitalier Universitaire de Liège Liège Belgium 4000
    51 Edumed - Educacao e Saude SA Curitiba Brazil 80440-080
    52 HSCM Montreal Quebec Canada H4J 1C5
    53 Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente" Concepción Chile 4070038
    54 Centro de Investigación del Maule Talca Chile 3465586
    55 Peking Union Medical College Hospital Beijing China 100032
    56 The First Hospital of Jilin University Changchun China 130021
    57 West China Hospital Chengdu China 610041
    58 The First Affiliated Hospital of Anhui Medical University Hefei China 230022
    59 Huashan Hospital, Fudan University Shanghai China 200040
    60 The First Hospital of Chinese Medical University Shenyang China 110001
    61 Institute of Rheumathology Prague Prague Czechia 12850
    62 Aarhus University Hospital Aarhus N Denmark 8200
    63 Odense University Hospital Odense Denmark 5000 C
    64 HYKS Keuhkosairauksien tutkimusyksikkö Helsinki Finland 00290
    65 TYKS Turku Finland 20521
    66 HOP Avicenne Bobigny France 93009
    67 HOP Louis Pradel Bron France 69677
    68 CHRU Lille Lille France 59037
    69 HOP Claude Huriez Lille France 59037
    70 HOP Arnaud de Villeneuve Montpellier France 34295
    71 HOP Hôtel-Dieu Nantes France 44093
    72 HOP Pasteur Nice France 06001
    73 HOP Bichat Paris France 75877
    74 HOP Pontchaillou Rennes France 35033
    75 HOP Charles Nicolle Rouen France 76000
    76 HOP Larrey Toulouse France 31059
    77 HOP Bretonneau Tours France 37044
    78 Klinik Donaustauf Donaustauf Germany 93093
    79 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
    80 Universitätsklinikum Erlangen Erlangen Germany 91054
    81 Universitätsmedizin Greifswald Greifswald Germany 17475
    82 Asklepios Klinik Altona Hamburg Germany 22763
    83 Medizinische Hochschule Hannover Hannover Germany 30625
    84 Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg Germany 69126
    85 Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24105
    86 Universitätsklinikum Münster Münster Germany 48149
    87 Universitätsklinikum Tübingen Tübingen Germany 72076
    88 General Hospital of Athens "Laiko" Athens Greece 11527
    89 Ramaiah Medical College and Hospitals Bangalore India 560054
    90 Post Graduate Institute of Medical Education and Research Chandigarh India 160012
    91 Sir Gangaram Hospital Delhi India 110060
    92 Care Hospital Hyderabad India 500034
    93 Nizam's Institute of Medical Sciences Hyderabad India 500082
    94 Asthma Bhawan Jaipur India 302039
    95 Getwell Hospital & Research Institute Nagpur India 440012
    96 All India Institute of Medical Sciences New Delhi India 110029
    97 B.J. Medical College and Sasoon General Hospital Pune India 411001
    98 Bnei Zion Medical Center, Haifa Haifa Israel 31048
    99 Rambam Medical Center Haifa Israel 3109601
    100 Rabin Medical Center Beilinson Petah Tiqwa Israel 49100
    101 Sourasky Medical Center Tel Aviv Israel 64239
    102 Università degli Studi di Genova Genova Italy 16132
    103 A.O. San Gerardo di Monza Monza Italy 20900
    104 A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli Napoli Italy 80138
    105 Università degli Studi Padova Padova Italy 35128
    106 Azienda Universitaria-Universita' La Sapienza Roma Italy 00161
    107 Tosei General Hospital Aichi, Seto Japan 489-8642
    108 Kurume University Hospital Fukuoka, Kurume Japan 830-0011
    109 Sapporo Medical University Hospital Hokkaido, Sapporo Japan 060-8543
    110 National Hospital Organization Himeji Medical Center Hyogo, Himeji Japan 670-8520
    111 St. Marianna University Hospital Kanagawa, Kawasaki Japan 216-8511
    112 Kitasato University Hospital Kanagawa, Sagamihara Japan 252-0375
    113 Kanagawa Cardiovascular and Respiratory Center Kanagawa, Yokohama Japan 236-0051
    114 Nagasaki University Hospital Nagasaki, Nagasaki Japan 852-8501
    115 Kindai University Hospital Osaka, Osakasayama Japan 589-8511
    116 National Hospital Organization Kinki-Chuo Chest Medical Center Osaka, Sakai Japan 591-8555
    117 Osaka Medical College Hospital Osaka, Takatsuki Japan 569-8686
    118 Saitama Medical University Hospital Saitama, Iruma-gun Japan 350-0495
    119 Hamamatsu University Hospital Shizuoka, Hamamatsu Japan 431-3192
    120 Tokushima University Hospital Tokushima, Tokushima Japan 770-8503
    121 Juntendo University Hospital Tokyo, Bunkyo-Ku Japan 113-8431
    122 Nippon Medical School Hospital Tokyo, Bunkyo-Ku Japan 113-8603
    123 Toho University Omori Medical Center Tokyo, Ota-ku Japan 143-8541
    124 Institute of Rheumatology Tokyo Women's Medical University Tokyo, Shinjyuku-ku Japan 162-0054
    125 Hospital Pulau Pinang Georgetown Pulau Pinang Malaysia 10990
    126 University of Malaya Medical Centre Kuala Lumpur Malaysia 59100
    127 Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas Ciudad de México Mexico 14080
    128 Amsterdam UMC Locatie VUMC Amsterdam Netherlands 1081HV
    129 Leids Universitair Medisch Centrum (LUMC) Leiden Netherlands 2333 ZA
    130 Radboud Universitair Medisch Centrum Nijmegen Netherlands 6525 GA
    131 Erasmus Medisch Centrum Rotterdam Netherlands 3015 CE
    132 Oslo Universitetssykehus HF, Rikshospitalet Oslo Norway N-0372
    133 Universitetssykehuset Nord-Norge, Tromsø Tromsø Norway N-9038
    134 Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz Bydgoszcz Poland 85168
    135 Specialist Allergy-Internist Center ALL-MED Krakow Poland 30033
    136 EMED, Center of Medical Services,Private Prac,Rzeszow Rzeszow Poland 35205
    137 Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw Wroclaw Poland 50-368
    138 Hospital Garcia de Orta, EPE Almada Portugal 2801-951
    139 Hospital Fernando Fonseca, EPE Amadora Portugal 2720-276
    140 CHUC - Centro Hospitalar e Universitário de Coimbra, EPE Coimbra Portugal 3000-075
    141 ULSAM, EPE - Hospital Conde de Bertiandos Ponte de Lima Portugal 4990-041
    142 Centro Hospitalar Universitário São João,EPE Porto Portugal 4200-319
    143 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal 4434-502
    144 Hospital Santa Creu i Sant Pau Barcelona Spain 08026
    145 Hospital Vall d'Hebron Barcelona Spain 08035
    146 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
    147 Hospital Universitario 12 de Octubre Madrid Spain 28041
    148 Hospital Dr. Peset Valencia Spain 46017
    149 Hospital Politècnic La Fe Valencia Spain 46026
    150 Hospital Álvaro Cunqueiro Vigo Spain 36312
    151 Clinical Rheumatology Research Center Sahlgrenska Gothenburg Sweden 413 45
    152 University Hospital Zurich Zürich Switzerland 8091
    153 Ramathibodi Hospital Bangkok Thailand 10400
    154 Srinagarind Hospital Muang Thailand 40002
    155 Songklanagarind Hospital Songkhla Thailand 90110
    156 Royal Free Hospital London United Kingdom NW3 2QG
    157 Guy's Hospital London United Kingdom SE1 9RT
    158 Royal Brompton Hospital London United Kingdom SW3 6NP
    159 Salford Royal Hospital Salford United Kingdom M6 8HD

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT03313180
    Other Study ID Numbers:
    • 1199-0225
    • 2016-003403-66
    First Posted:
    Oct 18, 2017
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial
    Nintedanib

    Study Results

    No Results Posted as of Aug 25, 2022