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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
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)
Secondary ID [1] 0 0
2015-000392-28
Secondary ID [2] 0 0
1199.214
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scleroderma, Systemic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [1] 0 0
up to week (wk) 52 after the start of administration
Secondary outcome [1] 0 0
Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52
Timepoint [1] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [2] 0 0
Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.
Timepoint [2] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [3] 0 0
Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks
Timepoint [3] 0 0
up to 52 weeks after the start of administration
Secondary outcome [4] 0 0
Absolute Change From Baseline in FVC in mL at Week 52
Timepoint [4] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [5] 0 0
Relative Change From Baseline [%] of mRSS at Week 52
Timepoint [5] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [6] 0 0
Time to Death
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)
Secondary outcome [7] 0 0
The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52
Timepoint [8] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [9] 0 0
Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52
Timepoint [9] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [10] 0 0
Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
Timepoint [10] 0 0
Baseline and up to 52 weeks after the start of administration
Secondary outcome [11] 0 0
Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52
Timepoint [11] 0 0
Baseline and up to 52 weeks after the start of administration

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2018
Sample size
Target
Accrual to date
Final
580
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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California
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Connecticut
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District of Columbia
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02597933