An randomized trial of two maintenance doses of Acthar Gel for patients with chronic pulmonary sarcoidosis. Patients will be observed for 24 weeks of treatment.
This is a multi-center double-blind trial to determine dose and effect size. A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States. After initial evaluation, including pulmonary function, CT and PET scanning, patients will be randomized to receive 80 Units if Acthar gel daily for 10days, followed by either 40 or 80 units of Acthar gel twice a week for an additional 22 weeks. At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGSteroid toxicity
Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
Time frame: 24 weeks
Forced Vital Capacity (FVC)
Change in FVC over course of study
Time frame: 24 weeks
Chest x-ray
Change in chest x-ray
Time frame: 24 weeks
PET scan
Change in lung uptake of PET scan during course of study
Time frame: 24 weeks
Sarcoidosis Health Questionnaire
Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire
Time frame: 24 weeks
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