Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS) (ACPS)

• ClinicalTrials.gov Identifier: NCT02188017
• Recruitment Status: Unknown
• First Posted: July 11, 2014
• Last Update Posted: December 8, 2015
• Sponsor: University of Cincinnati
• Collaborator: Mallinckrodt
• Information provided by (Responsible Party): Robert P Baughman, University of Cincinnati

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sarcoidosis; Pulmonary Sarcoidosis	Drug: Acthar gel	Phase 4

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
• Study Start Date: June 2014
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: September 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 80 units; 80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading	Drug: Acthar gel; Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week; Other Names: ACTH; Cortysin
Active Comparator: 40 units; 40 units of ACTHAR gel will be given twice a week for 22 weeks after loading	Drug: Acthar gel; Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week; Other Names: ACTH; Cortysin

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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 Criteria:

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.

Contacts and Locations

Contacts

Contact: Robert P Baughman, MD; 513-58405225; bob.baughman@uc.edu

Locations

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45267

Contact: Felicia Thompson 513-584-6252 THOMPSFA@ucmail.uc.edu

Principal Investigator: Robert P Baughman, MD

Sponsors and Collaborators

University of Cincinnati

Mallinckrodt

Investigators

• Principal Investigator: Robert P Baughman, MD; University of Cincinnati

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Robert P Baughman, Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT02188017
• Other Study ID Numbers: ACPS
• First Posted: July 11, 2014
• Last Update Posted: December 8, 2015
• Last Verified: December 2015

Keywords provided by Robert P Baughman, University of Cincinnati:

prednisone, methotrexate, sarcoidosis, azathioprine

Additional relevant MeSH terms:

Sarcoidosis, Pulmonary; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases