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

Primary Purpose

Sarcoidosis, Pulmonary Sarcoidosis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acthar gel
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring prednisone, methotrexate, sarcoidosis, azathioprine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

80 units

40 units

Arm Description

80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading

40 units of ACTHAR gel will be given twice a week for 22 weeks after loading

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2014
Last Updated
December 4, 2015
Sponsor
University of Cincinnati
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT02188017
Brief Title
Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)
Acronym
ACPS
Official Title
ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary Sarcoidosis
Keywords
prednisone, methotrexate, sarcoidosis, azathioprine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
80 units
Arm Type
Active Comparator
Arm Description
80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading
Arm Title
40 units
Arm Type
Active Comparator
Arm Description
40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
Intervention Type
Drug
Intervention Name(s)
Acthar gel
Other Intervention Name(s)
ACTH, Cortysin
Intervention Description
Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
Primary Outcome Measure Information:
Title
Steroid toxicity
Description
Cumulative toxicity between two arms of study over 24 weeks of study This will be assessed using a steroid toxicity questionnaire
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Change in FVC over course of study
Time Frame
24 weeks
Title
Chest x-ray
Description
Change in chest x-ray
Time Frame
24 weeks
Title
PET scan
Description
Change in lung uptake of PET scan during course of study
Time Frame
24 weeks
Title
Sarcoidosis Health Questionnaire
Description
Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert P Baughman, MD
Phone
513-58405225
Email
bob.baughman@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicia Thompson
Phone
513-584-6252
Email
THOMPSFA@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28353116
Citation
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.
Results Reference
derived

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Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

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