IRB: IRB00084227
Purpose of Study: Recruitment is underway in Baltimore for a research study of tofacitnib (a.k.a. Xeljanz®) for refractory dermatomyositis. This study will assess the efficacy and safety tofacitinib administered orally in patients with clinically active dermatomyositis who have shown inadequate response to corticosteroids or other first line immunosuppressive agents like methotrexate, azathioprine, or mycophenalate mofetil.
Eligibility Criteria:
Study volunteers must meet the following criteria:- Age > 18
- Have a biopsy-proven diagnosis of dermatomyositis
- Have active skin disease
- Have refractory myositis defined by active disease despite 12 weeks of steroids and with failure of response to at least prednisone and 1 other first line immunosuppressive agent OR have demonstrated significant toxicity or intolerance to such therapies
- Negative cancer screening
- Willing to come in for 8 on-site visits over 5 months (not including optional 12-week extension)
- Additional criteria apply and will be reviewed with the study team
Study Status:
Recruiting
ClinicalTrials.gov Link:
Specialty Center:
Myositis Center
Myositis Center
(410) 550-1741
myositisresearch@jhmi.edu
Principal Investigator:
Julie Paik, MD, MHS
Assistant Professor of Medicine
Dr. Paik’s clinical and research interests are focused on neuromuscular manifestations of autoimmune diseases, particularly in the areas of myositis and scleroderma. The focus of Dr. Paik’s current research efforts is in determining the mechanisms of muscle disease in scleroderma. Whereas her clinical practice is focused on the broad range of autoimmune and inflammatory muscle disease in rheumatology, there is a particular emphasis on the neuromuscular manifestations of scleroderma.
