Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02597933
Registration number
NCT02597933
Ethics application status
Date submitted
8/10/2015
Date registered
5/11/2015
Date last updated
13/12/2019
Titles & IDs
Public title
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Query!
Scientific 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)
Query!
Secondary ID [1]
0
0
2015-000392-28
Query!
Secondary ID [2]
0
0
1199.214
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Scleroderma, Systemic
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: Nintedanib - patient receives capsules containing nintedanib twice a day
Placebo comparator: Placebo - patient receives capsules identical to those containing active drug
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
up to week (wk) 52 after the start of administration
Query!
Secondary outcome [1]
0
0
Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [2]
0
0
Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [3]
0
0
Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks
Query!
Assessment method [3]
0
0
Annual rate of decline in FVC in percentage (%) predicted over 52 weeks.
For this endpoint reported means represent the adjusted rate.
Query!
Timepoint [3]
0
0
up to 52 weeks after the start of administration
Query!
Secondary outcome [4]
0
0
Absolute Change From Baseline in FVC in mL at Week 52
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [5]
0
0
Relative Change From Baseline [%] of mRSS at Week 52
Query!
Assessment method [5]
0
0
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).
Query!
Timepoint [5]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [6]
0
0
Time to Death
Query!
Assessment method [6]
0
0
Time to event analysis of patients with death. The number of observed patients with death are reported.
Query!
Timepoint [6]
0
0
From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)
Query!
Secondary outcome [7]
0
0
The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52
Query!
Assessment method [7]
0
0
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")
Query!
Timepoint [7]
0
0
Week 52
Query!
Secondary outcome [8]
0
0
Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [9]
0
0
Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [10]
0
0
Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Secondary outcome [11]
0
0
Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Baseline and up to 52 weeks after the start of administration
Query!
Eligibility
Key inclusion 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/11/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/11/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
580
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Liverpool Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [4]
0
0
St Vincent's Hospital Melbourne - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Washington
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Wisconsin
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Buenos Aires
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Florida
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Graz
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Innsbruck
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Bruxelles
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Gent
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Leuven
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Liège
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Curitiba
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Ontario
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Quebec
Query!
Country [41]
0
0
Chile
Query!
State/province [41]
0
0
Concepción
Query!
Country [42]
0
0
Chile
Query!
State/province [42]
0
0
Talca
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Beijing
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Changchun
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Chengdu
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Hefei
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Shanghai
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Shenyang
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Zhuzhou
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Prague
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Praha 4
Query!
Country [52]
0
0
Denmark
Query!
State/province [52]
0
0
Odense
Query!
Country [53]
0
0
Denmark
Query!
State/province [53]
0
0
Århus
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Helsinki
Query!
Country [55]
0
0
Finland
Query!
State/province [55]
0
0
Turku
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Bobigny
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Bron
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Lille
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Montpellier
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Nantes
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Nice
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Paris
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Rennes
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Rouen
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Toulouse
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Tours
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Bad Nauheim
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Donaustauf
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Dresden
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Erlangen
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Greifswald
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Hamburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Hannover
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Heidelberg
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Kiel
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Köln
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
München
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Münster
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Tübingen
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Athens
Query!
Country [81]
0
0
Hungary
Query!
State/province [81]
0
0
Budapest
Query!
Country [82]
0
0
India
Query!
State/province [82]
0
0
Bangalore
Query!
Country [83]
0
0
India
Query!
State/province [83]
0
0
Chandigarh
Query!
Country [84]
0
0
India
Query!
State/province [84]
0
0
Hyderabad
Query!
Country [85]
0
0
India
Query!
State/province [85]
0
0
Jaipur
Query!
Country [86]
0
0
India
Query!
State/province [86]
0
0
Mumbai
Query!
Country [87]
0
0
India
Query!
State/province [87]
0
0
Nagpur
Query!
Country [88]
0
0
India
Query!
State/province [88]
0
0
New Delhi
Query!
Country [89]
0
0
India
Query!
State/province [89]
0
0
Pune
Query!
Country [90]
0
0
India
Query!
State/province [90]
0
0
Vellore
Query!
Country [91]
0
0
Ireland
Query!
State/province [91]
0
0
Cork
Query!
Country [92]
0
0
Ireland
Query!
State/province [92]
0
0
Dublin 7
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Haifa
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Petah Tiqwa
Query!
Country [95]
0
0
Israel
Query!
State/province [95]
0
0
Tel Aviv
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Ancona
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Genova
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Monza
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Napoli
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Padova
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Roma
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Aichi, Seto
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Fukuoka, Kurume
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Hokkaido, Sapporo
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Hyogo, Himeji
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Iwate, Morioka
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Kanagawa, Kawasaki
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Kanagawa, Sagamihara
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Kanagawa, Yokohama
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Kyoto, Kyoto
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Nagasaki, Nagasaki
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Osaka, Osakasayama
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Osaka, Sakai
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Osaka, Takatsuki
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Saitama, Iruma-gun
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Shizuoka, Hamamatsu
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Tokushima, Tokushima
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Tokyo, Bunkyo-Ku
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Tokyo, Ota-ku
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Tokyo, Shinjyuku-ku
Query!
Country [121]
0
0
Malaysia
Query!
State/province [121]
0
0
Kuala Lumpur
Query!
Country [122]
0
0
Malaysia
Query!
State/province [122]
0
0
Pulau Pinang
Query!
Country [123]
0
0
Malaysia
Query!
State/province [123]
0
0
Selangor
Query!
Country [124]
0
0
Malaysia
Query!
State/province [124]
0
0
Seremban
Query!
Country [125]
0
0
Mexico
Query!
State/province [125]
0
0
Ciudad de México
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Amsterdam
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Leiden
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Nijmegen
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Rotterdam
Query!
Country [130]
0
0
Norway
Query!
State/province [130]
0
0
Oslo
Query!
Country [131]
0
0
Norway
Query!
State/province [131]
0
0
Tromsø
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Bydgoszcz
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Krakow
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Rzeszow
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Wroclaw
Query!
Country [136]
0
0
Portugal
Query!
State/province [136]
0
0
Almada
Query!
Country [137]
0
0
Portugal
Query!
State/province [137]
0
0
Amadora
Query!
Country [138]
0
0
Portugal
Query!
State/province [138]
0
0
Coimbra
Query!
Country [139]
0
0
Portugal
Query!
State/province [139]
0
0
Ponte de Lima
Query!
Country [140]
0
0
Portugal
Query!
State/province [140]
0
0
Porto
Query!
Country [141]
0
0
Portugal
Query!
State/province [141]
0
0
Vila Nova de Gaia
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Barcelona
Query!
Country [143]
0
0
Spain
Query!
State/province [143]
0
0
Madrid
Query!
Country [144]
0
0
Spain
Query!
State/province [144]
0
0
Santander
Query!
Country [145]
0
0
Spain
Query!
State/province [145]
0
0
Valencia
Query!
Country [146]
0
0
Spain
Query!
State/province [146]
0
0
Vigo
Query!
Country [147]
0
0
Sweden
Query!
State/province [147]
0
0
Gothenburg
Query!
Country [148]
0
0
Switzerland
Query!
State/province [148]
0
0
St. Gallen
Query!
Country [149]
0
0
Switzerland
Query!
State/province [149]
0
0
Zürich
Query!
Country [150]
0
0
Thailand
Query!
State/province [150]
0
0
Hat Yai
Query!
Country [151]
0
0
Thailand
Query!
State/province [151]
0
0
Muang
Query!
Country [152]
0
0
Thailand
Query!
State/province [152]
0
0
Ratchathewi
Query!
Country [153]
0
0
United Kingdom
Query!
State/province [153]
0
0
Glasgow
Query!
Country [154]
0
0
United Kingdom
Query!
State/province [154]
0
0
London
Query!
Country [155]
0
0
United Kingdom
Query!
State/province [155]
0
0
Salford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02597933
Query!
Trial related presentations / publications
Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2023 May 2;62(5):1870-1876. doi: 10.1093/rheumatology/keac535. Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6. Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2023 Feb 6;62(SI):SI43-SI53. doi: 10.1093/rheumatology/keac325. Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091. Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9. Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1. Roennow A, Sauve M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houyez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473. Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19. Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8. Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23. Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20. Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/33/NCT02597933/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/33/NCT02597933/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02597933
Download to PDF