Recruiting

Acthar Gel

Sponsor:

University of Cincinnati

Code:

NCT02188017

Conditions

Sarcoidosis

Pulmonary Sarcoidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acthar gel

Study Details

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.

Conditions

Sarcoidosis

Pulmonary Sarcoidosis

Study ID

NCT02188017

Start date

Jun, 2014

Status verified date

Dec, 2015

Completion date

Sep, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 80 units

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

active comparator: 40 units

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

Interventions

Acthar gel

Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week

Primary outcome measure

  • Steroid toxicity [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Robert P Baughman, MD

513-58405225bob.baughman@uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Felicia Thompson

513-584-6252THOMPSFA@ucmail.uc.edu

Principal Investigator:

Robert P Baughman, MD

More Information

Sponsor

University of Cincinnati

Last update posted

Dec 8, 2015

Last verified

Dec, 2015

Keywords

  • prednisone, methotrexate, sarcoidosis, azathioprine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2015-12-08.