Last updated on December 2018

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis


Brief description of study

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.

Clinical Study Identifier: NCT02597933

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University of California

Los Angeles, CA United States

University of California

Sacramento, CA United States

University of California

San Francisco, CA United States

Stanford University Medical Center

Stanford, CA United States

University of Colorado Denver

Aurora, CO United States

Yale University School of Medicine

New Haven, CT United States

Georgetown University

Washington, D.C., United States

University of Florida College of Medicine

Jacksonville, FL United States

University of Miami

Miami, FL United States

The Emory Clinic

Atlanta, GA United States

Northwestern University

Chicago, IL United States

University of Chicago

Chicago, IL United States

University of Iowa

Iowa City, IA United States

Univeristy of Kansas Medical Center

Kansas City, KS United States

University of Louisville

Louisville, KY United States

Tulane University Hospital and Clinic

New Orleans, LA United States

Johns Hopkins Scleroderma Center

Baltimore, MD United States

Massachusetts General Hospital

Boston, MA United States

Boston Medical Center

Boston, MA United States

University of Michigan Health System

Ann Arbor, MI United States

Henry Ford Health System

Detroit, MI United States

University of Minnesota Masonic Cancer Center

Minneapolis, MN United States

Mayo Clinic-Rochester

Rochester, MN United States

The Lung Research Center, LLC

Chesterfield, MO United States

Washington University School of Medicine

Saint Louis, MO United States

Hospital for Special Surgery

New York, NY United States

Ichan School of Medicine at Mount Sinai

New York, NY United States

Duke University Medical Center

Durham, NC United States

University of Cincinnati Health

Cincinnati, OH United States

Cole Eye Institute

Cleveland, OH United States

University of Toledo

Toledo, OH United States

The Univ of PA Perelman Ctr for Advncd Medicine

Philadelphia, PA United States

Thomas Jefferson University

Philadelphia, PA United States

Temple University Hospital

Philadelphia, PA United States

Medical University of South Carolina

Charleston, SC United States

University of South Carolina

Columbia, SC United States

Vanderbilt Pulmonary Clinic

Nashville, TN United States

The University Of Texas at Houston

Houston, TX United States

University of Utah Health Sciences Center

Salt Lake City, UT United States

Inova Fairfax Medical Campus

Falls Church, VA United States

Virginia Mason Medical Center

Seattle, WA United States

University of Washington

Seattle, WA United States

Froedtert Hospital

Milwaukee, WI United States

Hospital Militar Central

Buenos Aires, Argentina

APRILLUS

Ciudad Autonoma Buenos Aires, Argentina

Liverpool Hospital

Sydney, Australia

Royal Adelaide Hospital

Adelaide, Australia

St Vincents Melbourne

Fitzroy, Australia

Brussels - UNIV Erasme

Bruxelles, Belgium

Brussels - UNIV St-Luc

Bruxelles, Belgium

UNIV UZ Gent

Gent, Belgium

UZ Leuven

Leuven, Belgium

Edumed - Educacao e Saude SA

Curitiba, Brazil

Saint Joseph's Healthcare

Hamilton, ON Canada

Mount Sinai Hospital

Toronto, ON Canada

Jewish General Hospital

Montreal, QC Canada

HSCM

Montreal, QC Canada

Beijing Hospital

Beijing, China

West China Hospital

Chengdu, China

Zhuzhou Central Hospital

Zhuzhou, China

Thomayer Hospital

Praha 4, Czechia

Odense Universitetshospital

Odense, Denmark

Aarhus Universitetshospital

Århus, Denmark

HYKS Keuhkosairauksien

Helsinki, Finland

HOP Avicenne

Bobigny, France

HOP de la Cavale Blanche

Brest, France

HOP Claude Huriez

Lille cedex, France

HOP Calmette

Lille, France

HOP Arnaud de Villeneuve

Montpellier, France

HOP H tel-Dieu

Nantes, France

HOP Pasteur

Nice, France

HOP Cochin

Paris, France

HOP Bichat

Paris, France

HOP Pontchaillou

Rennes, France

HOP Charles Nicolle

Rouen cedex, France

HOP Larrey

Toulouse, France

HOP Bretonneau

Tours, France

Kerckhoff-Klinik, Bad Nauheim

Bad Nauheim, Germany

Krankenhaus, Donaustauf

Donaustauf, Germany

Universit tsklinikum Erlangen

Erlangen, Germany

Universit tsmedizin Greifswald

Greifswald, Germany

Asklepios Klinik Altona

Hamburg, Germany

Universit tsklinikum M nster

Münster, Germany

Universit tsklinikum T bingen

Tübingen, Germany

St John's Medical College

Bangalore, India

Mazumdar Shaw Medical centre

Bangalore, India

Care Hospital

Hyderabad, India

Fortis Hospital

Kolkata, India

Sir Gangaram Hospital

New Delhi, India

Christian Medical College

Vellore, India

Cork University Hospital

Cork, Ireland

Rambam Medical Center

Haifa, Israel

Rabin Medical Center Beilinson

Petah Tiqwa, Israel

Sourasky Medical Center

Tel Aviv, Israel

Tosei General Hospital

Aichi, Seto, Japan

Kurume University Hospital

Fukuoka, Kurume, Japan

Sapporo Medical University Hospital

Hokkaido, Sapporo, Japan

Iwate Medical University Hospital

Iwate, Morioka, Japan

Kitasato University Hospital

Kanagawa, Sagamihara, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Kindai University Hospital

Osaka, Osakasayama, 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

VU Medisch Centrum

Amsterdam, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Hospital Garcia de Orta, EPE

Almada, Portugal

Hospital Fernando Fonseca, EPE

Amadora, Portugal

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, Portugal

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Dr. Peset

Valencia, Spain

Hospital Polit cnic La Fe

Valencia, Spain

Universit tsspital Z rich

Zürich, Switzerland

Glasgow Royal Infirmary

Glasgow, United Kingdom

Royal Free Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

Salford Royal Hospital

Salford, United Kingdom

Recruitment Status: Closed


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