April 2024

The UPMC Myositis Center in the Division of Rheumatology & Clinical Immunology, is conducting a study entitled, “Myositis Interstitial Lung Disease Nintedanib Trial (MINT)”.

UPMC Myositis Center physicians and collaborating UPMC pulmonologists (Simmons Center for ILD) are requesting that you consider referring your ILD patients with clinical myositis (or those with positive for myositis autoantibodies) for this novel de-centralized clinical trial that will test the safety and effectiveness of Nintedanib in patients with myositis associated interstitial lung disease. This unique study does not require any travel or in-person clinic visits and patients from anywhere in US can participate. Interested patients will be initially pre-screened through review of medical records followed by enrollment and screening remotely via telemedicine. After screening, all study visits will be completed virtually via telemedicine with the assistance of home research nurses and digital health technologies. Components of the study visit that typically require in-person staff involvement (e.g. blood draws, pulmonary function tests, and chest CT scans) could be completed through home research nurses, home monitoring devices, outside laboratories or be done at the location where participants routinely receive their care. We have successfully enrolled patients from various parts of USA.

Key inclusion criteria:

1. ≥ 18 years of age and living in the United States
2. Confirmed diagnosis of clinical myositis or the presence of any myositis specific autoantibody (anti-Jo1, PL7, PL12, EJ, OJ, KS, SRP, HMGCR, MDA5, SAE, Mi-2, NXP2, SSA/B, Ku, PM-Scl, RNP, TIF-1)
3. Confirmed diagnosis of fibrosing interstitial lung disease based on a high-resolution CT scan in the last 12-months

See detailed protocol synopsis or visit study website for more information.

www.mint.pitt.edu

Visit clinicaltrial.gov: Mint Study (NCT05799755)

https://clinicaltrials.gov/study/NCT05799755?distance=50&term=NCT05799755

We believe that the collaboration between academic and practicing physicians in clinical trials is of paramount importance. If your referred patient is enrolled in the MINT trial, you are considered a physician collaborator with the possibility of being a co-author on the supplementary manuscripts (if authorship criteria is fulfilled) as well as having access to the study data for research in this area (if study is approved).

Study Contacts:

Study Manager: Sol Dominguez; Phone: 412-648-4005;  Email

UPMC Myositis Center Investigators:

    Rohit Aggarwal MD, MS – Professor of Medicine Email

    Chester Oddis, MD – Professor of Medicine Email

UPMC Simmons ILD Center Investigators:

    Kevin Gibson, MD – Professor of Medicine Email

    Daniel Kass, MD – Associate Professor of Medicine Email