Start Date
October 31, 2016
Primary Completion Date
May 22, 2019
Study Completion Date
May 22, 2019
Acthar low dose (40 U)
The 40U group will administer 0.5 mL of study medication once a day. Patients will taper study medication during Week 2 through the remainder of the study and will administer 0.5 mL of study medication twice a week. The stable Acthar regimen should be maintained for the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Acthar high dose (80 U)
The 80U group will administer 1.0 mL of study medication every day. If a patient meets dose reduction criteria, their assigned volume will be adjusted from 1.0 mL to 0.5 mL. Patients will taper study medication during Week 2 through the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Collaborators (1)
Mallinckrodt
INDUSTRY
NYU Langone Health
OTHER