Back to resultsTolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study
Primary Purpose
Interstitial Lung Disease, Myopathy, Inflammatory
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nintedanib 150 milligrams [Ofev]
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease
Eligibility Criteria
Inclusion Criteria:
1. 18 years and older 2. Diagnosis of autoimmune myopathy (dermatomyositis, polymyositis, overlap myositis or anti-synthetase syndrome) as diagnosed by a rheumatologist.
3. Interstitial lung disease confirmed by high resolution CT scan (Extent of disease 10% or more on CT done within 12 months of enrolment) with evidence of fibrosis, defined as reticular abnormality with traction bronchiectasis with or without honeycombing.
4. Evidence of progressive disease within 24 months of screening visit:
- Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of >=10%
- Marginal decline in FVC % pred based on a relative decline of .>=5-<10% combined with worsening of respiratory symptoms
- Marginal decline in FVC % pred based on a relative decline of >=5-<10% combined with increasing extent of fibrotic changes on chest imaging
- Worsening of respiratory symptoms such as cough or shortness of breath as well as increasing extent of fibrotic changes on chest imaging as per radiologist or pulmonologist who read the scan 5. Current and ongoing treatment with immunosuppressive medications, on a stable medication regimen and dosage for at least 6 weeks (considered standard of care medical therapy) Concomitant medications allowed are:
- mycophenolate,
- azathioprine,
- tacrolimus,
- cyclosporine,
- rituximab (injection within the last year),
- prednisone low dose =<20 mg daily,
- Intravenous immunoglobulins
Exclusion Criteria:
- Contraindication to treatment with nintedanib (based on Canadian labeling)
- The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- The male patient plans to father a child during the course of the study
- Hypersensitivity to nintedanib, peanut or soy
- Elevated liver enzymes greater than 1.5 times the upper limit of normal
- Creatinine clearance <30 mL/min
- Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension
Sites / Locations
- Research Institute McGill University Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nintedanib treatment
Arm Description
Single arm treatment with nintedanib
Outcomes
Primary Outcome Measures
Tolerability - completed doses
Percentage of subjects who complete 24 weeks on nintedanib. Subjects will be considered to have completed the 24 weeks of the study if they took 90% of the study drug doses.
Safety and adverse events
numbers of patients with adverse events during course of the study
Secondary Outcome Measures
Change in forced vital capacity
Change in diffusion capacity of the lung for carbon monoxide
Change in 6 minute walking distance
Full Information
NCT ID
NCT05335278
First Posted
April 13, 2022
Last Updated
April 13, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT05335278
Brief Title
Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study
Official Title
Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression.
The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Myopathy, Inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nintedanib treatment
Arm Type
Experimental
Arm Description
Single arm treatment with nintedanib
Intervention Type
Drug
Intervention Name(s)
Nintedanib 150 milligrams [Ofev]
Intervention Description
All patients will be given nintedanib 150 milligrams orally twice daily
Primary Outcome Measure Information:
Title
Tolerability - completed doses
Description
Percentage of subjects who complete 24 weeks on nintedanib. Subjects will be considered to have completed the 24 weeks of the study if they took 90% of the study drug doses.
Time Frame
24 weeks
Title
Safety and adverse events
Description
numbers of patients with adverse events during course of the study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in forced vital capacity
Time Frame
24 weeks
Title
Change in diffusion capacity of the lung for carbon monoxide
Time Frame
24 weeks
Title
Change in 6 minute walking distance
Time Frame
24 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 18 years and older 2. Diagnosis of autoimmune myopathy (dermatomyositis, polymyositis, overlap myositis or anti-synthetase syndrome) as diagnosed by a rheumatologist.
3. Interstitial lung disease confirmed by high resolution CT scan (Extent of disease 10% or more on CT done within 12 months of enrolment) with evidence of fibrosis, defined as reticular abnormality with traction bronchiectasis with or without honeycombing.
4. Evidence of progressive disease within 24 months of screening visit:
Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of >=10%
Marginal decline in FVC % pred based on a relative decline of .>=5-<10% combined with worsening of respiratory symptoms
Marginal decline in FVC % pred based on a relative decline of >=5-<10% combined with increasing extent of fibrotic changes on chest imaging
Worsening of respiratory symptoms such as cough or shortness of breath as well as increasing extent of fibrotic changes on chest imaging as per radiologist or pulmonologist who read the scan 5. Current and ongoing treatment with immunosuppressive medications, on a stable medication regimen and dosage for at least 6 weeks (considered standard of care medical therapy) Concomitant medications allowed are:
mycophenolate,
azathioprine,
tacrolimus,
cyclosporine,
rituximab (injection within the last year),
prednisone low dose =<20 mg daily,
Intravenous immunoglobulins
Exclusion Criteria:
Contraindication to treatment with nintedanib (based on Canadian labeling)
The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
The male patient plans to father a child during the course of the study
Hypersensitivity to nintedanib, peanut or soy
Elevated liver enzymes greater than 1.5 times the upper limit of normal
Creatinine clearance <30 mL/min
Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatemeh Vaezi-Poor
Phone
5149341934
Email
fatemeh.vaezi-poor@muhc.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Assayag, MD
Organizational Affiliation
Research Institute - McGill University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatemeh Vaezi-Poor
Phone
514-934-1934
Email
fatemeh.vaezi-poor@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Deborah Assayag, MD
12. IPD Sharing Statement
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Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study
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