AzTrials
AzTrials

Scleroderma, SystemicPhase 3NCT02597933

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

A Phase 3 study testing Nintedanib in people with Scleroderma, Systemic, run by Boehringer Ingelheim at 195 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma, Systemic
What is being tested?
Nintedanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
580 participants
Where
195 sitesin 32 countries
Study dates
12 Nov 2015to 28 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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)

Trial locations and contacts

195 sites in 32 countries.

195 sites in 32 countries

United States44 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati Health

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of South Carolina

    Columbia, South Carolina, 29203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The University Of Texas at Houston

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Miami

    Miami, Florida, 33125

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt Pulmonary Clinic

    Nashville, Tennessee, 37232-5735

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Hospital for Special Surgery

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

  • University of California Davis

    Sacramento, California, 95817

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84108

  • University of California San Francisco

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5236

  • University of Toledo

    Toledo, Ohio, 43614

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan20 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Sapporo Medical University Hospital

    Hokkaido, Sapporo, 060-8543

  • National Hospital Organization Himeji Medical Center

    Hyogo, Himeji, 670-8520

  • Iwate Medical University Hospital

    Iwate, Morioka, 020-8505

  • St. Marianna University School of Medicine Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Kindai University Hospital

    Osaka, Osakasayama, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Osaka Medical College Hospital

    Osaka, Takatsuki, 569-8686

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Juntendo University Hospital

    Tokyo, Bunkyo-Ku, 113-8431

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-Ku, 113-8603

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541

  • Institute of Rheumatology Tokyo Women's Medical University

    Tokyo, Shinjyuku-ku, 162-0054

Other trials in Japan

India15 sites

  • St John's Medical College

    Bangalore, 560 034

  • Ramaiah Medical College and Hospitals

    Bangalore, 560054

  • Mazumdar Shaw Medical centre

    Bangalore, 560099

  • Postgraduate Institute of Medical Education And Research

    Chandigarh, 160012

  • Care Hospital

    Hyderabad, 500034

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Asthma Bhawan

    Jaipur, 302039

  • P.D. Hinduja National Hospital

    Mumbai, 400016

  • Getwell Hospital & Research Institute

    Nagpur, 440012

  • All India Institute of Medical Science

    New Delhi, 110029

  • Sir Gangaram Hospital

    New Delhi, 110060

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, 411 001

  • B.J. Medical College and Sasoon General Hospital

    Pune, 411001

  • Inamdar Multispeciality Hospital

    Pune, 411040

  • Christian Medical College

    Vellore, 632 004

Other trials in India

France13 sites

  • HOP Avicenne

    Bobigny, 93009

  • HOP Louis Pradel

    Bron, 69677

  • HOP Calmette

    Lille, 59037

  • HOP Claude Huriez

    Lille, 59037

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Hôtel-Dieu

    Nantes, 44000

  • HOP Pasteur

    Nice, 06001

  • HOP Cochin

    Paris, 75014

  • HOP Bichat

    Paris, 75018

  • HOP Pontchaillou

    Rennes, 35033

  • HOP Charles Nicolle

    Rouen, 76000

  • HOP Larrey

    Toulouse, 31059

  • HOP Bretonneau

    Tours, 37044

Other trials in France

Germany13 sites

  • Kerckhoff-Klinik, Bad Nauheim

    Bad Nauheim, 61231

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Klinik Donaustauf

    Donaustauf, 93093

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Klinikum der Universität München - Campus Großhadern

    München, 80336

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

China9 sites

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Beijing Chao-Yang Hospital

    Beijing

  • Beijing Hospital

    Beijing

  • First Hospital of Jilin University

    Changchun

  • West China Hospital

    Chengdu, 610041

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The First Hospital of Chinese Medical University

    Shenyang

  • Zhuzhou Central Hospital

    Zhuzhou, 412007

Other trials in China

Spain8 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Dr. Peset

    Valencia, 46017

  • Hospital Politècnic La Fe

    Valencia, 46026

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Italy6 sites

  • Az. Ospedaliere Umberto I di Ancona

    Ancona, 60126

  • Università degli Studi di Genova

    Genova, 16132

  • A.O. San Gerardo di Monza

    Monza, 20900

  • A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

    Naples, 80138

  • Università degli Studi Padova

    Padova, 35128

  • Azienda Universitaria-Universita' La Sapienza

    Roma, 00161

Other trials in Italy

Portugal6 sites

  • Hospital Garcia de Orta, EPE

    Almada, 2801-951

  • Hospital Fernando Fonseca, EPE

    Amadora, 2720-276

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • ULSAM, EPE - Hospital Conde de Bertiandos

    Ponte de Lima, 4990-041

  • Centro Hospitalar São João,EPE

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Belgium5 sites

  • ULB Hopital Erasme

    Brussels, 1070

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • UNIV UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

United Kingdom5 sites

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's Hospital

    London, SE1 9RT

  • Royal Brompton Hospital

    London, SW3 6NP

  • Salford Royal Hospital

    Salford, M6 8HD

Other trials in United Kingdom

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Liverpool Hospital

    Sydney, New South Wales, 2170

Other trials in Australia

Israel4 sites

  • Bnei Zion Medical Center, Haifa

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 3109601

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Malaysia4 sites

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Selayang

    Kuala Selangor, 68100

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • Hospital Tuanku Ja'afar

    Seremban, 70300

Other trials in Malaysia

Netherlands4 sites

  • VU Medisch Centrum

    Amsterdam, 1081HV

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Poland4 sites

  • Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz

    Bydgoszcz, 85168

  • Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow

    Krakow, 31011

  • EMED, Center of Medical Services,Private Prac,Rzeszow

    Rzeszów, 35205

  • Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw

    Wroclaw, 50 368

Other trials in Poland

Argentina3 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, C1426BOR

  • APRILLUS-Asistencia e Investigación

    Ciudad Autonoma Buenos Aires, C1046AAQ

  • CEMER-Centro Medico De Enfermedades Respiratorias

    Florida, B1602DQD

Other trials in Argentina

Canada3 sites

  • Saint Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • HSCM

    Montreal, Quebec, H4J 1C5

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

Other trials in Canada

Thailand3 sites

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital

    Muang, 40002

  • Ramathibodi Hospital

    Ratchathewi, 10400

Other trials in Thailand

Austria2 sites

  • LKH-Univ. Hospital Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

Other trials in Austria

Chile2 sites

  • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

    Concepción, 4070038

  • Centro de Investigación del Maule

    Talca, 3465586

Other trials in Chile

Czechia2 sites

  • Institute of Rheumathology Prague

    Prague, 12850

  • Thomayer Hospital

    Prague, 14059

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitets Hospital

    Aarhus, 8000

  • Odense Universitetshospital

    Odense, 5000 C

Other trials in Denmark

Finland2 sites

  • HYKS Keuhkosairauksien

    Helsinki, 00290

  • TYKS, Keuhkosairauksien klinikka, Turku

    Turku, 20520

Other trials in Finland

Greece2 sites

  • General Hospital of Athens "Laiko"

    Athens, 115 27

  • General Hospital of Athens "Laiko"

    Athens, 11527

Other trials in Greece

Ireland2 sites

  • Cork University Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin

Other trials in Ireland

Norway2 sites

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9038

Other trials in Norway

Switzerland2 sites

  • Kantonspital St. Gallen, Rheumatologie Department

    Sankt Gallen, 9007

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Brazil1 site

  • Edumed - Educacao e Saude SA

    Curitiba, 80440-080

Other trials in Brazil

Hungary1 site

  • Semmelweis University, Dept. Pulmonology

    Budapest, 1125

Other trials in Hungary

Mexico1 site

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

    Mexico City, 14080

Other trials in Mexico

Sweden1 site

  • Clinical Rheumatology Research Center Sahlgrenska

    Gothenburg, 413 45

Other trials in Sweden

About this study

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)

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.

Being tested
Nintedanib, Placebo
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NintedanibDrug

  • PlaceboDrug

Study groups in NCT02597933
Study groupRoleWhat they receive
NintedanibExperimentalpatient receives capsules containing nintedanib twice a day
Receives: Drug: Nintedanib
PlaceboPlacebo comparatorpatient receives capsules identical to those containing active drug
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

    Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.

    For this endpoint reported means represent the adjusted rate.

    Measured: up to week (wk) 52 after the start of administration

Secondary outcomes (11)

  1. Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52

    This is the first key secondary endpoint.

    The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.

    The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.

    Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  2. Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.

    This is the second key secondary endpoint.

    The Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health.

    Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  3. Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks

    Annual rate of decline in FVC in percentage (%) predicted over 52 weeks.

    For this endpoint reported means represent the adjusted rate.

    Measured: up to 52 weeks after the start of administration

  4. Absolute Change From Baseline in FVC in mL at Week 52

    Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  5. Relative Change From Baseline [%] of mRSS at Week 52

    Relative change from baseline [%] of mRSS at Week 52.

    The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.

    The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.

    Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  6. Time to Death

    Time to event analysis of patients with death. The number of observed patients with death are reported.

    Measured: From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)

  7. The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52

    The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52.

    This is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient's global impression of overall health Visual Analogue Scale (VAS) and physician's global impression of patient's overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension.

    The CRISS index score represents a probability of improvement and ranges between 0 and 1.

    This is a 2 stage process to predict probability of improvement:

    Step 1 - absence of major organ progression (SRC etc.) - score "0" Step 2 - predicted probability of improvement - (score "0 - 1")

    Measured: Week 52

  8. Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52

    Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52.

    Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  9. Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52

    Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52.

    It is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked "Yes") at the corresponding visit

    Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  10. Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

    Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.

    The HAQ-DI score is calculated as follows:

    Each question is scored 0-3 (where 0= "without difficulty" \& 3= "unable to do"). There are 8 categories (Dressing \& Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category.

    Finally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated.

    The HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment.

    Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

  11. Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52

    Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52.

    FACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4).

    A raw score is calculated as: Sum individual item scores * 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9.

    The FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea.

    Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).

    Measured: Baseline and up to 52 weeks after the start of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2015 (estimated)
  2. Study start12 Nov 2015
  3. Primary completion31 Oct 2018
  4. Study completion28 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02597933
Sponsor's protocol ID
1199.214
Other IDs
2015-000392-28, 2015
Status last verified
Nov 2019
First submitted
8 Oct 2015
Last updated
13 Dec 2019

Publications

  • Smith V, Denton CP, Herrick AL, Ittrich C, Alves M, Cutolo M. Nailfold capillaroscopy in patients with systemic sclerosis-associated interstitial lung disease: a substudy of the SENSCIS trial. RMD Open. 2025 Oct 17;11(4):e005704. doi: 10.1136/rmdopen-2025-005704.

    PubMed 41107055

  • 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.

    PubMed 40233987

  • 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.

    PubMed 37357024

  • 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.

    PubMed 37294870

  • 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.

    PubMed 36111858

  • 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.

    PubMed 35790961

  • 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.

    PubMed 35640959

  • 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.

    PubMed 35150246

  • 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.

    PubMed 35012623

  • 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.

    PubMed 33412120

  • 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.

    PubMed 33328257

  • 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.

    PubMed 33223487

  • 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.

    PubMed 33142016

  • 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.

    PubMed 32243207

  • 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.

    PubMed 31112379

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib in people with Scleroderma, Systemic, run by Boehringer Ingelheim at 195 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Japan, India, France, Germany and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (time frame: up to week (wk) 52 after the start of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02597933, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.

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