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

Primary Purpose

Scleroderma, Systemic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham
  • University of California Los Angeles
  • University of California Davis
  • University of California San Francisco
  • Stanford University Medical Center
  • University of Colorado Denver
  • Yale University School of Medicine
  • Georgetown University
  • University of Florida College of Medicine
  • University of Miami
  • The Emory Clinic
  • Northwestern University
  • University of Iowa
  • University of Kansas Medical Center
  • University of Louisville
  • Tulane University Hospital and Clinic
  • Johns Hopkins Hospital
  • Boston Medical Center
  • University of Michigan Health System
  • University of Minnesota Masonic Cancer Center
  • Mayo Clinic-Rochester
  • The Lung Research Center, LLC
  • Washington University School of Medicine
  • Hospital for Special Surgery
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center-New York Presbyterian Hospital
  • Duke University Medical Center
  • University of Cincinnati Health
  • Cleveland Clinic
  • University of Toledo
  • Penn State Milton S. Hershey Medical Center
  • University of Pennsylvania
  • Thomas Jefferson University
  • Temple University Hospital
  • Medical University of South Carolina
  • University of South Carolina
  • Vanderbilt Pulmonary Clinic
  • University of Texas Southwestern Medical Center
  • The University Of Texas at Houston
  • University of Utah Health Sciences Center
  • Inova Fairfax Medical Campus
  • Virginia Mason Medical Center
  • University of Washington
  • Froedtert and The Medical College of Wisconsin
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • APRILLUS-Asistencia e Investigación
  • CEMER-Centro Medico De Enfermedades Respiratorias
  • Royal Prince Alfred Hospital
  • Liverpool Hospital
  • Royal Adelaide Hospital
  • St Vincent's Hospital Melbourne
  • LKH-Univ. Hospital Graz
  • Medical University of Innsbruck
  • ULB Hopital Erasme
  • Brussels - UNIV Saint-Luc
  • UNIV UZ Gent
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Edumed - Educacao e Saude SA
  • Saint Joseph's Healthcare
  • Mount Sinai Hospital
  • HSCM
  • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
  • Centro de Investigación del Maule
  • Peking Union Medical College Hospital
  • Beijing Chao-Yang Hospital
  • Beijing Hospital
  • First Hospital of Jilin University
  • West China Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Huashan Hospital, Fudan University
  • The First Hospital of Chinese Medical University
  • Zhuzhou Central Hospital
  • Institute of Rheumathology Prague
  • Thomayer Hospital
  • Odense Universitetshospital
  • Aarhus Universitets Hospital
  • HYKS Keuhkosairauksien
  • TYKS, Keuhkosairauksien klinikka, Turku
  • HOP Avicenne
  • HOP Louis Pradel
  • HOP Calmette
  • HOP Claude Huriez
  • HOP Arnaud de Villeneuve
  • HOP Hôtel-Dieu
  • HOP Pasteur
  • HOP Cochin
  • HOP Bichat
  • HOP Pontchaillou
  • HOP Charles Nicolle
  • HOP Larrey
  • HOP Bretonneau
  • Kerckhoff-Klinik, Bad Nauheim
  • Klinik Donaustauf
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Universitätsklinikum Erlangen
  • Universitätsmedizin Greifswald
  • Asklepios Klinik Altona
  • Medizinische Hochschule Hannover
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Universitätsklinikum Köln (AöR)
  • Klinikum der Universität München - Campus Großhadern
  • Universitätsklinikum Münster
  • Universitätsklinikum Tübingen
  • General Hospital of Athens "Laiko"
  • General Hospital of Athens "Laiko"
  • Semmelweis University, Dept. Pulmonology
  • St John's Medical College
  • Ramaiah Medical College and Hospitals
  • Mazumdar Shaw Medical centre
  • Postgraduate Institute of Medical Education And Research
  • Care Hospital
  • Nizam's Institute of Medical Sciences
  • Asthma Bhawan
  • P.D. Hinduja National Hospital
  • Getwell Hospital & Research Institute
  • All India Institute of Medical Science
  • Sir Gangaram Hospital
  • Jehangir Clinical Development Centre Pvt. Ltd.
  • B.J. Medical College and Sasoon General Hospital
  • Inamdar Multispeciality Hospital
  • Christian Medical College
  • Cork University Hospital
  • Mater Misericordiae University Hospital
  • Bnei Zion Medical Center, Haifa
  • Rambam Medical Center
  • Rabin Medical Center Beilinson
  • Sourasky Medical Center
  • Az. Ospedaliere Umberto I di Ancona
  • Università degli Studi di Genova
  • A.O. San Gerardo di Monza
  • A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
  • Università degli Studi Padova
  • Azienda Universitaria-Universita' La Sapienza
  • Tosei General Hospital
  • Kurume University Hospital
  • Sapporo Medical University Hospital
  • National Hospital Organization Himeji Medical Center
  • Iwate Medical University Hospital
  • St. Marianna University School of Medicine Hospital
  • Kitasato University Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Kyoto University Hospital
  • Nagasaki University Hospital
  • Kindai University Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Osaka Medical College Hospital
  • Saitama Medical University Hospital
  • Hamamatsu University Hospital
  • Tokushima University Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • Toho University Omori Medical Center
  • Institute of Rheumatology Tokyo Women's Medical University
  • University Malaya Medical Centre
  • Hospital Pulau Pinang
  • Hospital Selayang
  • Hospital Tuanku Ja'afar
  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
  • VU Medisch Centrum
  • Leids Universitair Medisch Centrum (LUMC)
  • Radboud Universitair Medisch Centrum
  • Erasmus Medisch Centrum
  • Oslo Universitetssykehus HF, Rikshospitalet
  • Universitetssykehuset Nord-Norge, Tromsø
  • Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
  • Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
  • EMED, Center of Medical Services,Private Prac,Rzeszow
  • Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
  • Hospital Garcia de Orta, EPE
  • Hospital Fernando Fonseca, EPE
  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • ULSAM, EPE - Hospital Conde de Bertiandos
  • Centro Hospitalar São João,EPE
  • Centro Hospitalar de Vila Nova de Gaia
  • Hospital Vall d'Hebron
  • Hospital Santa Creu i Sant Pau
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Dr. Peset
  • Hospital Politècnic La Fe
  • Hospital Álvaro Cunqueiro
  • Clinical Rheumatology Research Center Sahlgrenska
  • Kantonspital St. Gallen, Rheumatologie Department
  • Universitätsspital Zürich
  • Songklanagarind Hospital
  • Srinagarind Hospital
  • Ramathibodi Hospital
  • Glasgow Royal Infirmary
  • Royal Free Hospital
  • Guy's Hospital
  • Royal Brompton Hospital
  • Salford Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nintedanib

Placebo

Arm Description

patient receives capsules containing nintedanib twice a day

patient receives capsules identical to those containing active drug

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2015
Last Updated
November 26, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02597933
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2015 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nintedanib
Arm Type
Experimental
Arm Description
patient receives capsules containing nintedanib twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patient receives capsules identical to those containing active drug
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Description
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.
Time Frame
up to week (wk) 52 after the start of administration
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks
Description
Annual rate of decline in FVC in percentage (%) predicted over 52 weeks. For this endpoint reported means represent the adjusted rate.
Time Frame
up to 52 weeks after the start of administration
Title
Absolute Change From Baseline in FVC in mL at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Relative Change From Baseline [%] of mRSS at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Time to Death
Description
Time to event analysis of patients with death. The number of observed patients with death are reported.
Time Frame
From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)
Title
The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52
Description
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")
Time Frame
Week 52
Title
Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration
Title
Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52
Description
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).
Time Frame
Baseline and up to 52 weeks after the start of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5236
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Vanderbilt Pulmonary Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5735
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University Of Texas at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
APRILLUS-Asistencia e Investigación
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
CEMER-Centro Medico De Enfermedades Respiratorias
City
Florida
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
LKH-Univ. Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Edumed - Educacao e Saude SA
City
Curitiba
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
Saint Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
HSCM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Centro de Investigación del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
Country
China
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The First Hospital of Chinese Medical University
City
Shenyang
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
ZIP/Postal Code
412007
Country
China
Facility Name
Institute of Rheumathology Prague
City
Prague
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Thomayer Hospital
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
Facility Name
Aarhus Universitets Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
HYKS Keuhkosairauksien
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
TYKS, Keuhkosairauksien klinikka, Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
HOP Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
HOP Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HOP Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
HOP Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
HOP Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
HOP Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
HOP Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Kerckhoff-Klinik, Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Klinik Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Köln (AöR)
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum der Universität München - Campus Großhadern
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Semmelweis University, Dept. Pulmonology
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
St John's Medical College
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Ramaiah Medical College and Hospitals
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Mazumdar Shaw Medical centre
City
Bangalore
ZIP/Postal Code
560099
Country
India
Facility Name
Postgraduate Institute of Medical Education And Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Care Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Asthma Bhawan
City
Jaipur
ZIP/Postal Code
302039
Country
India
Facility Name
P.D. Hinduja National Hospital
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
Getwell Hospital & Research Institute
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
All India Institute of Medical Science
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sir Gangaram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd.
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
B.J. Medical College and Sasoon General Hospital
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Inamdar Multispeciality Hospital
City
Pune
ZIP/Postal Code
411040
Country
India
Facility Name
Christian Medical College
City
Vellore
ZIP/Postal Code
632 004
Country
India
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin 7
Country
Ireland
Facility Name
Bnei Zion Medical Center, Haifa
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Az. Ospedaliere Umberto I di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Università degli Studi di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. San Gerardo di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Università degli Studi Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Universitaria-Universita' La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo, Himeji
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Iwate, Morioka
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kanagawa, Kawasaki
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto, Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Osaka, Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Osaka, Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Saitama, Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima, Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-Ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo, Bunkyo-Ku
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Tokyo, Ota-ku
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Institute of Rheumatology Tokyo Women's Medical University
City
Tokyo, Shinjyuku-ku
ZIP/Postal Code
162-0054
Country
Japan
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Selayang
City
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Tuanku Ja'afar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
City
Ciudad de México
ZIP/Postal Code
14080
Country
Mexico
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Radboud Universitair Medisch Centrum
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Oslo Universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge, Tromsø
City
Tromsø
ZIP/Postal Code
N-9038
Country
Norway
Facility Name
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85168
Country
Poland
Facility Name
Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow
City
Krakow
ZIP/Postal Code
31011
Country
Poland
Facility Name
EMED, Center of Medical Services,Private Prac,Rzeszow
City
Rzeszow
ZIP/Postal Code
35205
Country
Poland
Facility Name
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
City
Wroclaw
ZIP/Postal Code
50 368
Country
Poland
Facility Name
Hospital Garcia de Orta, EPE
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospital Fernando Fonseca, EPE
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
ULSAM, EPE - Hospital Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Centro Hospitalar São João,EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Clinical Rheumatology Research Center Sahlgrenska
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Kantonspital St. Gallen, Rheumatologie Department
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36111858
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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.
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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.
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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.
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PubMed Identifier
33328257
Citation
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.
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PubMed Identifier
33223487
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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.
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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.
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Links:
URL
http://trials.boehringer-ingelheim.com
Description
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A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

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