A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
NCT ID: NCT02597933
Last Updated: 2019-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
580 participants
INTERVENTIONAL
2015-11-12
2018-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nintedanib
patient receives capsules containing nintedanib twice a day
Nintedanib
Placebo
patient receives capsules identical to those containing active drug
Placebo
Interventions
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Nintedanib
Placebo
Eligibility Criteria
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Inclusion Criteria
* 2013 American College of Rheumatology (ACR) / EULAR classification criteria for SSc fulfilled
* SSc disease onset (defined by first non-Raynaud symptom) within 7 years
* SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung \>= 10%
* FVC \>= 40% of predicted normal
* Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
Exclusion Criteria
* Bilirubin \>1.5 x ULN
* Creatinine clearance \<30 mL/min
* Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC \<0.7)
* Other clinically significant pulmonary abnormalities
* Significant Pulmonary Hypertension (PH)
* Cardiovascular diseases
* More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
* Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
* international normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN)
* History of thrombotic event within last year
* Clinical signs of malabsorption or needing parenteral nutrition
* Previous treatment with nintedanib or pirfenidone
* Treatment with prednisone \>10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and cyclosporine A, potassium para-aminobenzoate
* Unstable background therapy with either mycophenolate mofetil or methotrexate
* Previous or planned hematopoietic stem cell transplantation
* Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
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
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, 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 Health
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 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
University of South Carolina
Columbia, South Carolina, United States
Vanderbilt Pulmonary Clinic
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University Of Texas 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
LKH-Univ. Hospital Graz
Graz, , Austria
Medical University of Innsbruck
Innsbruck, , Austria
ULB Hopital Erasme
Brussels, , Belgium
Brussels - UNIV Saint-Luc
Brussels, , Belgium
UNIV UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Edumed - Educacao e Saude SA
Curitiba, , Brazil
Saint Joseph's Healthcare
Hamilton, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
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
Beijing Chao-Yang Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
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 Chinese Medical University
Shenyang, , China
Zhuzhou Central Hospital
Zhuzhou, , China
Institute of Rheumathology Prague
Prague, , Czechia
Thomayer Hospital
Prague, , Czechia
Aarhus Universitets Hospital
Aarhus, , Denmark
Odense Universitetshospital
Odense, , Denmark
HYKS Keuhkosairauksien
Helsinki, , Finland
TYKS, Keuhkosairauksien klinikka, Turku
Turku, , Finland
HOP Avicenne
Bobigny, , France
HOP Louis Pradel
Bron, , France
HOP Calmette
Lille, , France
HOP Claude Huriez
Lille, , France
HOP Arnaud de Villeneuve
Montpellier, , France
HOP Hôtel-Dieu
Nantes, , France
HOP Pasteur
Nice, , France
HOP Cochin
Paris, , France
HOP Bichat
Paris, , France
HOP Pontchaillou
Rennes, , France
HOP Charles Nicolle
Rouen, , France
HOP Larrey
Toulouse, , France
HOP Bretonneau
Tours, , France
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
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
Klinikum der Universität München - Campus Großhadern
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
General Hospital of Athens "Laiko"
Athens, , Greece
General Hospital of Athens "Laiko"
Athens, , Greece
Semmelweis University, Dept. Pulmonology
Budapest, , Hungary
St John's Medical College
Bangalore, , India
Ramaiah Medical College and Hospitals
Bangalore, , India
Mazumdar Shaw Medical centre
Bangalore, , India
Postgraduate Institute of Medical Education And Research
Chandigarh, , India
Care Hospital
Hyderabad, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
Asthma Bhawan
Jaipur, , India
P.D. Hinduja National Hospital
Mumbai, , India
Getwell Hospital & Research Institute
Nagpur, , India
All India Institute of Medical Science
New Delhi, , India
Sir Gangaram Hospital
New Delhi, , India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, , India
B.J. Medical College and Sasoon General Hospital
Pune, , India
Inamdar Multispeciality Hospital
Pune, , India
Christian Medical College
Vellore, , India
Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
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
Az. Ospedaliere Umberto I di Ancona
Ancona, , Italy
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
Iwate Medical University Hospital
Iwate, Morioka, , Japan
St. Marianna University School of Medicine Hospital
Kanagawa, Kawasaki, , Japan
Kitasato University Hospital
Kanagawa, Sagamihara, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Kyoto University Hospital
Kyoto, Kyoto, , 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
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Selayang
Kuala Selangor, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
Hospital Tuanku Ja'afar
Seremban, , Malaysia
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Mexico City, , Mexico
VU Medisch Centrum
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
Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
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 São João,EPE
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Dr. Peset
Valencia, , Spain
Hospital Politècnic La Fe
Valencia, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Clinical Rheumatology Research Center Sahlgrenska
Gothenburg, , Sweden
Kantonspital St. Gallen, Rheumatologie Department
Sankt Gallen, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Songklanagarind Hospital
Hat Yai, , Thailand
Srinagarind Hospital
Muang, , Thailand
Ramathibodi Hospital
Ratchathewi, , Thailand
Glasgow Royal Infirmary
Glasgow, , United Kingdom
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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Volkmann ER, Assassi S, Denton CP, Simonovska R, Sambevski S, Alves M, Bernstein EJ. Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies. J Rheumatol. 2025 Sep 1;52(9):914-918. doi: 10.3899/jrheum.2024-1063.
Volkmann ER, McMahan ZH, Smith V, Jouneau S, Miede C, Alves M, Herrick AL; SENSCIS Trial Investigators. Risk of Malnutrition in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo-Controlled SENSCIS Trial. Arthritis Care Res (Hoboken). 2023 Dec;75(12):2501-2507. doi: 10.1002/acr.25176. Epub 2023 Aug 7.
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.
Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2023 May 2;62(5):1870-1876. doi: 10.1093/rheumatology/keac535.
Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6.
Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2023 Feb 6;62(SI):SI43-SI53. doi: 10.1093/rheumatology/keac325.
Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091.
Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9.
Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1.
Roennow A, Sauve M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houyez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.
Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.
Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.
Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23.
Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.
Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-000392-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.214
Identifier Type: -
Identifier Source: org_study_id