Clinical trial NCT02597933: A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Official title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scleroderma, Systemic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.


Eligibility criteria: Inclusion criteria:

* Age \>= 18 years
* 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:

* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \>1.5 x ULN
* 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)

Primary outcomes:
measure: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
timeFrame: up to week (wk) 52 after the start of administration
Secondary outcomes:
measure: Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks
timeFrame: up to 52 weeks after the start of administration
measure: Absolute Change From Baseline in FVC in mL at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Relative Change From Baseline [%] of mRSS at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Time to Death
timeFrame: From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)
measure: The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52
timeFrame: Week 52
measure: Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
measure: Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52
timeFrame: Baseline and up to 52 weeks after the start of administration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Health
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Pulmonary Clinic
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University Of Texas at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: APRILLUS-Asistencia e Investigación
city: Florida
country: Argentina
facility: CEMER-Centro Medico De Enfermedades Respiratorias
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Graz
country: Austria
facility: LKH-Univ. Hospital Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Curitiba
country: Brazil
facility: Edumed - Educacao e Saude SA
city: Hamilton
country: Canada
facility: Saint Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: HSCM
state: Quebec
city: Concepción
country: Chile
facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
city: Talca
country: Chile
facility: Centro de Investigación del Maule
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Changchun
country: China
facility: First Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Shenyang
country: China
facility: The First Hospital of Chinese Medical University
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Prague
country: Czechia
facility: Institute of Rheumathology Prague
city: Praha 4
country: Czechia
facility: Thomayer Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Århus
country: Denmark
facility: Aarhus Universitets Hospital
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien
city: Turku
country: Finland
facility: TYKS, Keuhkosairauksien klinikka, Turku
city: Bobigny
country: France
facility: HOP Avicenne
city: Bron
country: France
facility: HOP Louis Pradel
city: Lille
country: France
facility: HOP Calmette
city: Lille
country: France
facility: HOP Claude Huriez
city: Montpellier
country: France
facility: HOP Arnaud de Villeneuve
city: Nantes
country: France
facility: HOP Hôtel-Dieu
city: Nice
country: France
facility: HOP Pasteur
city: Paris
country: France
facility: HOP Cochin
city: Paris
country: France
facility: HOP Bichat
city: Rennes
country: France
facility: HOP Pontchaillou
city: Rouen
country: France
facility: HOP Charles Nicolle
city: Toulouse
country: France
facility: HOP Larrey
city: Tours
country: France
facility: HOP Bretonneau
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik, Bad Nauheim
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Köln
country: Germany
facility: Universitätsklinikum Köln (AöR)
city: München
country: Germany
facility: Klinikum der Universität München - Campus Großhadern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Budapest
country: Hungary
facility: Semmelweis University, Dept. Pulmonology
city: Bangalore
country: India
facility: St John's Medical College
city: Bangalore
country: India
facility: Ramaiah Medical College and Hospitals
city: Bangalore
country: India
facility: Mazumdar Shaw Medical centre
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education And Research
city: Hyderabad
country: India
facility: Care Hospital
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
city: Jaipur
country: India
facility: Asthma Bhawan
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital
city: Nagpur
country: India
facility: Getwell Hospital & Research Institute
city: New Delhi
country: India
facility: All India Institute of Medical Science
city: New Delhi
country: India
facility: Sir Gangaram Hospital
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd.
city: Pune
country: India
facility: B.J. Medical College and Sasoon General Hospital
city: Pune
country: India
facility: Inamdar Multispeciality Hospital
city: Vellore
country: India
facility: Christian Medical College
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
city: Haifa
country: Israel
facility: Bnei Zion Medical Center, Haifa
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center Beilinson
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Ancona
country: Italy
facility: Az. Ospedaliere Umberto I di Ancona
city: Genova
country: Italy
facility: Università degli Studi di Genova
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Napoli
country: Italy
facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
city: Padova
country: Italy
facility: Università degli Studi Padova
city: Roma
country: Italy
facility: Azienda Universitaria-Universita' La Sapienza
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Hyogo, Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Iwate, Morioka
country: Japan
facility: Iwate Medical University Hospital
city: Kanagawa, Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kanagawa, Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Kyoto, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Nagasaki, Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka, Osakasayama
country: Japan
facility: Kindai University Hospital
city: Osaka, Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Osaka, Takatsuki
country: Japan
facility: Osaka Medical College Hospital
city: Saitama, Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tokushima, Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo, Bunkyo-Ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Bunkyo-Ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo, Shinjyuku-ku
country: Japan
facility: Institute of Rheumatology Tokyo Women's Medical University
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Selangor
country: Malaysia
facility: Hospital Selayang
city: Seremban
country: Malaysia
facility: Hospital Tuanku Ja'afar
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge, Tromsø
city: Bydgoszcz
country: Poland
facility: Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
city: Krakow
country: Poland
facility: Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
city: Rzeszow
country: Poland
facility: EMED, Center of Medical Services,Private Prac,Rzeszow
city: Wroclaw
country: Poland
facility: Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca, EPE
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
city: Ponte de Lima
country: Portugal
facility: ULSAM, EPE - Hospital Conde de Bertiandos
city: Porto
country: Portugal
facility: Centro Hospitalar São João,EPE
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Gothenburg
country: Sweden
facility: Clinical Rheumatology Research Center Sahlgrenska
city: St. Gallen
country: Switzerland
facility: Kantonspital St. Gallen, Rheumatologie Department
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
city: Muang
country: Thailand
facility: Srinagarind Hospital
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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