Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2014-06-30
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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80 units
80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading
Acthar gel
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
40 units
40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
Acthar gel
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
Interventions
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Acthar gel
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
University of Cincinnati
OTHER
Responsible Party
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Robert P Baughman
Professor
Principal Investigators
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Robert P Baughman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Baughman RP, Sweiss N, Keijsers R, Birring SS, Shipley R, Saketkoo LA, Lower EE. Repository corticotropin for Chronic Pulmonary Sarcoidosis. Lung. 2017 Jun;195(3):313-322. doi: 10.1007/s00408-017-9994-4. Epub 2017 Mar 28.
Other Identifiers
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ACPS
Identifier Type: -
Identifier Source: org_study_id