Clinical trials

TMA medical advisor Dr. Rohit Aggarwal and Dr. Chester Oddis are recruiting patients with active interstitial lung disease (ILD) and antisynthetase antibody (Jo-1, PL-7, PL-12, EJ, OJ, KS), for a myositis clinical trial. Patients do not need to have active myositis symptoms. The trial is to test the effect of adding abatacept to standard-of-care immunosuppressive therapy.

Abatacept is a biologic agent that is already FDA-approved for rheumatoid arthritis. Because there is evidence that activated T-cells play a role in myositis-associated ILD, researchers want to test its effect in this new disease indication.

The multi-center, double-blind, placebo-controlled study will enroll 20 patients to receive weekly subcutaneous injections of either the treatment or placebo over the six-month trial. Patients will continue their standard-of-care immunosuppressive therapy throughout the trial. Patients may opt to participate in a six-week, open-label extension, in which all patients will receive the treatment. The study entails five to six in-person visits at the study site.
Study sites include Cedars-Sinai Medical Center in California, University of Colorado Anschutz Medical Center in Denver, Johns Hopkins Medical Center in Baltimore, Brigham & Women’s Hospital in Boston, and the University of Pittsburgh.

More information, including study sites and inclusion criteria, is available here.

Please contact study coordinator Courtney Ward at 412-648-9989 or cow24@pitt.edu.

8 comments on “Clinical trial: Attack My-ILD”

  1. 1
    Marianne Moyer on June 17, 2019

    Are you interested in a patient with necrotizing myopathy with ILD? I do not have anti-synthesase syndrome. I would be interested in participating in the trial. I’ve had active ILD for over 15 years. The information above seems to say you only want ILD AND antisynthesase but I thought I’d ask.

    1. 2
      Linda Kobert on June 18, 2019

      Marianne, this is the inclusion criteria for this study from ClinicalTrials.gov: “Anti-synthetase syndrome defined as the patient possessing 1 antisynthetase autoantibody (Jo-1, PL-12, PL-7, KS, OJ, EJ, Zo) in the presence of autoimmune ILD.” So it looks like you would not qualify.
      However, you may qualify for another trial of this medication. Please see the Bristol-Myers Squibb trial for abatacept: https://www.clinicaltrials.gov/ct2/show/NCT02971683?term=abatacept&cond=myositis&rank=2

  2. 3
    Tracey Stefanelli on September 10, 2019

    How do you get on a trial if you live on Long Island ny ? My sister has this disease but can not travel that far
    Do you have any trials that are in NY?

  3. 5
    Sherry Newbanks on October 3, 2019

    Hi Linda,
    I have dermatomyositis with ILD. Was diagnosed at the Mayo in 2003. I had antiJo 1 and antisynthetetase at that time. Not sure about now. How can this med take care of the scarring in my lungs? I am on oxygen 24/7. I live in Wyoming.

    1. 6
      Linda Kobert on October 7, 2019

      Hello Sherry, I’m sorry your have to deal with this. It is believed that autoantibodies are basically forever. The scarring is too, I’m afraid. The Attack My-ILD trial does not have a site near Wyoming, however the drug company has another trial with a site in Omaha: https://www.clinicaltrials.gov/ct2/show/study/NCT02971683

  4. 7
    Janet Chastain on October 3, 2019

    How about Florida? I live in Cocoa, Fl – Is there anything happening near here?

    1. 8
      Linda Kobert on October 7, 2019

      Hello Janet. The Attack My-ILD trial does not have a site near Florida. However, the drug company is running another trial with this drug for myositis with sites in Ft. Lauderdale and Miami. You can call the contact person at one of those sites to ask if you qualify. https://www.clinicaltrials.gov/ct2/show/study/NCT02971683?show_locs=Y#locn

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