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Tyrosine Kinase Inhibitor

Nintedanib 150 milligrams [Ofev] for Inflammatory Myopathy

N/A

Waitlist Available

Led By Deborah Assayag, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is looking at whether or not a medication called nintedanib is safe and helpful for people with myositis-associated interstitial lung disease. People with this disease often also have to take immunosuppressive drugs, which can make it difficult to participate in clinical trials like this one. The study authors think that it's important to study this group of patients separately, because they tend to respond differently to drugs than other people with lung diseases.

Eligible Conditions

Inflammatory Myopathy
Interstitial Lung Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events

Tolerability - completed doses

Secondary outcome measures

Change in 6 minute walking distance

Change in diffusion capacity of the lung for carbon monoxide

Change in forced vital capacity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nintedanib treatmentExperimental Treatment1 Intervention

Single arm treatment with nintedanib

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Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

442 Previous Clinical Trials

159,149 Total Patients Enrolled

Deborah Assayag, MDPrincipal InvestigatorResearch Institute - McGill University Health Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects have been enrolled in this clinical trial?

"Affirmative. According to the information on clinicaltrials.gov, this medical study is actively looking for qualified participants; it was first posted in June 2021 and recently edited in April 2022 with a goal of recruiting 25 individuals from 1 site."

Answered by AI

Is there still availability for participants in this investigation?

"Affirmative. Clinicaltrials.gov currently holds evidence that this research is actively seeking participants, with the trial having been first published on June 1st 2021 and last updated April 13th 2022. 25 volunteers are needed at one medical facility for enrolment into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study

Deborah Assayag 2021. "Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05335278.

All > Myositis > Ofev