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

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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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188017


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

Locations
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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
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Principal Investigator: Robert P Baughman, MD University of Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert P Baughman, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02188017    
Other Study ID Numbers: ACPS
First Posted: July 11, 2014    Key Record Dates
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:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases