Clinical Trial: Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Cincinnati

Current Primary Outcome: Steroid toxicity [ Time Frame: 24 weeks ]

Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Forced Vital Capacity (FVC) [ Time Frame: 24 weeks ]
    Change in FVC over course of study
  • Chest x-ray [ Time Frame: 24 weeks ]
    Change in chest x-ray
  • PET scan [ Time Frame: 24 weeks ]
    Change in lung uptake of PET scan during course of study
  • Sarcoidosis Health Questionnaire [ Time Frame: 24 weeks ]
    Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: April 24, 2014
Date Started: June 2014
Date Completion: September 2017
Last Updated: December 4, 2015
Last Verified: December 2015