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Trial · Interventional

Status unknownPhase 4Registry data

Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Short name ACPS

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
20 participants (estimated)
Sponsor
University of Cincinnati · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jun 2014
Primary completion
Dec 2016 (estimated)
Completion
Sept 2017 (estimated)
First posted
11 Jul 2014 (estimated)
Last update posted
8 Dec 2015 (estimated)
Conditions
Sarcoidosis · Pulmonary Sarcoidosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 4

    ACPS

    NCT02188017

    Jun 2014 to est. Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Acthar gelDrug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Steroid toxicity

    Time frame · 24 weeks

    Registry description

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

Secondary outcomes(4)
  1. Forced Vital Capacity (FVC)

    Time frame · 24 weeks

    Registry description

    Change in FVC over course of study

  2. Chest x-ray

    Time frame · 24 weeks

    Registry description

    Change in chest x-ray

  3. PET scan

    Time frame · 24 weeks

    Registry description

    Change in lung uptake of PET scan during course of study

  4. Sarcoidosis Health Questionnaire

    Time frame · 24 weeks

    Registry description

    Change in quality of life as assessed by King's Sarcoidosis Health Questionnaire

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

5 results

Repository corticotropin for Chronic Pulmonary Sarcoidosis.

Baughman et al. 2017Lungcited by 64

PMID 28353116PMC5437201DOI 10.1007/s00408-017-9994-4PUB-28353116

CC BY5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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