Trial Information

Summary: People with myositis are asked to participate in a research study being conducted by North Shore – LIJ Health System

You may be eligible to participate in this study if you:

• Are at least 18 years of age
• Have been diagnosed with myositis

You may not participate in this study if you:

• Have received the study drug MEDI-545 in previous clinical trials
• Have a history of allergy or reaction to any component of the MEDI-545 formulation
• Weigh greater than or equal to 264 pounds (120 kg)
• Have received more than 20 mg/day of prednisone or a similar drug within 14 days before entry into the study
• Have inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy
• Have a history of or a family history of noninflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles
• Have received the following dosages of medication prior to entry to the study: hydroxychloroquine (Plaquenil) -greater than 600mg/day, mycophenolate mofetil (Cellcept) - greater than 3g/day, methotrexate (Trexall) greater than - 25 mg/week, leflunomide (Arava) - greater than 20 mg/day, azathioprine (Imuran) - greater than 3mg/kg/day or any dose of dapsone, cyclophosphamide (Cytoxan), cyclosporine (Neoral or Sandimmue) or thalidomide (Thalomid)
• Have received different doses of antimalarials (chloroquine (Aralen), mefloquine (Lariam), primaquine, pyrimethamine (Daraprim), and quinine), mycophenolate mofetil (Cellcept), methotrexate (Trexall), leflunomide (Plaquenill), or azathioprine (Imuran) within 28 prior to study entry or oral corticosteroids within 14 days prior to study entry
• Have a history of severe viral infections such as herpes or cytomegalovirus
• Have evidence of infection with hepatitis B or C or active infection of hepatitis A
• Have evidence of infection with HIV-1 or HIV-2
• Have been vaccinated with live attenuated (weakened) viruses (such as the flu or measles, mumps, rubella vaccines) within 21 before entry into the study
• History of alcohol or drug abuse or history of cancer for less than 1 year prior to study entry
• Are pregnant, breastfeeding, or intend to become pregnant during the study
• Have participated in another research study within the last 30 days

If you would like to learn more about participating in this study, please send an e-mail message using the form below.