Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2015-000392-28-IE |
Date of registration:
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13/04/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis
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Scientific title:
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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) - Nintedanib in SSc-ILD |
Date of first enrolment:
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27/06/2016 |
Target sample size:
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750 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000392-28 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Chile
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China
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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India
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Ireland
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Israel
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Italy
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Japan
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Malaysia
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Mexico
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Netherlands
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Norway
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Poland
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Portugal
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Spain
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Sweden
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Switzerland
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim |
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Age >= 18 years
- 2013 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 HRCT; Extent of fibrotic disease in the lung >= 10%
- FVC >= 40% of predicted normal
- DLCO 30% to 89% of predicted normal
Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria: - AST, ALT >1.5 x ULN
- Bilirubin >1.5 x ULN
- Creatinine clearance <30 mL/min
- Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
- Other clinically significant pulmonary abnormalities
- Significant pulmonary hypertension
- Cardiovascular diseases
- More than 3 digital fingertip 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, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine 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)
- Patients with a history of Scleroderma Renal Crisis
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
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Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1
Level: LLT
Classification code 10012977
Term: Diffuse systemic sclerosis
System Organ Class: 100000004859
MedDRA version: 19.1
Level: LLT
Classification code 10036814
Term: Progressive systemic sclerosis
System Organ Class: 100000004859
MedDRA version: 19.1
Level: PT
Classification code 10042954
Term: Systemic sclerosis pulmonary
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1
Level: LLT
Classification code 10025109
Term: Lung involvement in systemic sclerosis
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1
Level: LLT
Classification code 10042953
Term: Systemic sclerosis
System Organ Class: 100000004859
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Intervention(s)
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Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To demonstrate efficacy in regard to skin fibrosis at week 52 and to demonstrate an improvement of patient's symptoms at week 52
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Main Objective: To demonstrate a reduction in the annual rate of decline in FVC in mL over 52 weeks
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Timepoint(s) of evaluation of this end point: 1: 52 weeks
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Primary end point(s): 1: Annual rate of decline in FVC in mL
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Secondary Outcome(s)
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Secondary end point(s): 1: Absolute change from baseline in the mRSS
2: Absolute change from baseline in SGRQ total score
3: Annual rate of decline in FVC in percent predicted
4: Absolute change from baseline in FVC in mL
5: Relative change from baseline (%) of mRSS
6: Time to all-cause mortality
7: Absolute change from baseline at week 52 in CRISS index score
8: Absolute change from baseline in DLCO in percent predicted
9: Absolute change from baseline in digital ulcer net burden
10: Absolute change from baseline in HAQ-DI score
11: Absolute change from baseline in FACIT dyspnoea score
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Timepoint(s) of evaluation of this end point: 1: 52 weeks
2: 52 weeks
3: 52 weeks
4: 52 weeks
5: 52 weeks
6: 52 weeks
7: 52 weeks
8: 52 weeks
9: 52 weeks
10: 52 weeks
11: 52 weeks
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Secondary ID(s)
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1199.214
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2015-000392-28-NL
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Source(s) of Monetary Support
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Boehringer Ingelheim
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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