Nintedanib 150 milligrams [Ofev] for Myopathy, Inflammatory

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Institute McGill University Health Center, Montréal, Canada
Myopathy, Inflammatory+4 More
Nintedanib 150 milligrams [Ofev] - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Myopathy, Inflammatory
  • Lung Diseases, Interstitial

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myopathy, Inflammatory

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 24 weeks

24 weeks
Change in 6 minute walking distance
Change in diffusion capacity of the lung for carbon monoxide
Change in forced vital capacity
Safety and adverse events
Tolerability - completed doses

Trial Safety

Safety Progress

1 of 3

Other trials for Myopathy, Inflammatory

Trial Design

1 Treatment Group

Nintedanib treatment
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Nintedanib 150 milligrams [Ofev] · No Placebo Group · N/A

Nintedanib treatment
Drug
Experimental Group · 1 Intervention: Nintedanib 150 milligrams [Ofev] · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Closest Location: Research Institute McGill University Health Center · Montréal, Canada
Photo of quebec 1Photo of quebec 2Photo of quebec 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Myopathy, Inflammatory
0 CompletedClinical Trials

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
388 Previous Clinical Trials
124,255 Total Patients Enrolled
Deborah Assayag, MDPrincipal InvestigatorResearch Institute - McGill University Health Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of autoimmune myopathy.
You have a clinically significant decline in FVC % pred based on a relative decline of ≥10% from baseline.
You are taking azathioprine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.