Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188017
Recruitment Status : Unknown
Verified December 2015 by Robert P Baughman, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date December 8, 2015
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Forced Vital Capacity (FVC) [ Time Frame: 24 weeks ]
    Change in FVC over course of study
  • Chest x-ray [ Time Frame: 24 weeks ]
    Change in chest x-ray
  • PET scan [ Time Frame: 24 weeks ]
    Change in lung uptake of PET scan during course of study
  • Sarcoidosis Health Questionnaire [ Time Frame: 24 weeks ]
    Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)
Official Title  ICMJE ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoidosis
  • Pulmonary Sarcoidosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 80 units
    80 units ACTHAR gel will be given twice a week for 22 weeks after initial loading
    Intervention: Drug: Acthar gel
  • Active Comparator: 40 units
    40 units of ACTHAR gel will be given twice a week for 22 weeks after loading
    Intervention: Drug: Acthar gel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188017
Other Study ID Numbers  ICMJE ACPS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P Baughman, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Robert P Baughman, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP