Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80 units | Active Comparator | 80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading |
|
| 40 units | Active Comparator | 40 units of ACTHAR gel will be given twice a week for 22 weeks after loading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar gel | Drug | Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steroid toxicity | Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | Change in FVC over course of study | 24 weeks |
| Chest x-ray | Change in chest x-ray | 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
adrenal insufficiency (Addison's disease)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert P Baughman, MD | Contact | 513-58405225 | bob.baughman@uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert P Baughman, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28353116 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2017 | |
| Reset | May 30, 2017 | |
| Release | Feb 1, 2018 | |
| Reset | Feb 28, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2017 | May 30, 2017 | |||
| Feb 1, 2018 |
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
Not provided
Not provided
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PET scan | Change in lung uptake of PET scan during course of study | 24 weeks |
| Sarcoidosis Health Questionnaire | Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire | 24 weeks |
| Feb 28, 2018 |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |