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NCT05799755 · ClinicalTrials.gov registry record · Phase 4
Myositis Interstitial Lung Disease Nintedanib Trial
A Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD), sponsored by Rohit Aggarwal, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
- 10
- Study locations
NCT05799755 is a Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD) that has completed, run by Rohit Aggarwal, MD. The registered enrollment target is 49 participants. The trial reports 10 study locations across 9 states.
The verdict
NCT05799755, a Phase 4 study of Myositis Associated Interstitial Lund Disease (MA-ILD), has completed, sponsored by Rohit Aggarwal, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
- 10
- Study locations
Study Summary
This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Standard of Care
- DRUG Nintedanib
Study Locations (10)
New York
- Columbia University Irving Medical Center - New York
- Northwell Health - New York
Alabama
- University of Alabama - Birmingham
Arizona
- Mayo Clinic Arizona - Scottsdale
Colorado
- National Jewish Health - Denver
Florida
- University of South Florida - Tampa
Illinois
- University of Chicago - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05799755
The ClinicalTrials.gov registry entry for NCT05799755 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rohit Aggarwal, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myositis Associated Interstitial Lund Disease (MA-ILD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05799755 reports 10 study locations spanning 9 distinct geographic areas - top geographies include New York, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05799755 about?
NCT05799755 is a clinical study titled "Myositis Interstitial Lung Disease Nintedanib Trial". This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs...
What is the current status of trial NCT05799755?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2023-08-01. Estimated completion is 2025-12-31.
What conditions does trial NCT05799755 study?
This clinical trial studies the following conditions: Myositis Associated Interstitial Lund Disease (MA-ILD).
What interventions are being tested in trial NCT05799755?
The interventions under investigation include: Placebo (DRUG), Standard of Care (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT05799755?
This trial is sponsored by Rohit Aggarwal, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05799755 being conducted?
This trial has 10 study locations across Alabama, Arizona, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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