Status:
TERMINATED
Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Interstitial Lung Disease
Myopathy, Inflammatory
Eligibility:
All Genders
18+ years
Phase:
NA
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 fib...
Eligibility Criteria
Inclusion
- 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:
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- mycophenolate,
- azathioprine,
- tacrolimus,
- cyclosporine,
- rituximab (injection within the last year),
- prednisone low dose =\<20 mg daily,
- Intravenous immunoglobulins
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05335278
Start Date
June 1 2021
End Date
April 30 2025
Last Update
September 2 2025
Active Locations (1)
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1
Research Institute McGill University Health Center
Montreal, Quebec, Canada, H4A3J1