Status:
UNKNOWN
Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Mallinckrodt
Conditions:
Sarcoidosis
Pulmonary Sarcoidosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 Description
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. A...
Eligibility Criteria
Inclusion
- Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23
- Patient on \>5 mg prednisone for pulmonary indications
- FVC \<85% predicted
- Prednisone dose not reduced in prior 3 months
- Deterioration of pulmonary disease over the past year
- Decrease in FVC \>5%
- Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).
Exclusion
- adrenal insufficiency (Addison's disease)
- Scleroderma
- a fungal infection
- herpes infection of the eyes
- osteoporosis
- a stomach ulcer
- congestive heart failure
- high blood pressure
- recent surgery
- if you are allergic to pork proteins
- Do not receive a smallpox vaccine or any "live" vaccine while you are using corticotropin.
- Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab) in prior six months
- Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids
- Patients requiring therapy for pulmonary hypertension
- Females of childbearing potential who are known to be pregnant and/or lactating or who have a positive urine pregnancy test on screening.
- Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days)
- Any other condition that the investigator feels would pose a significant hazard to the patient if Acthar Gel therapy is initiated.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02188017
Start Date
June 1 2014
End Date
September 1 2017
Last Update
December 8 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267