NCT02188017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

April 24, 2014

Last Update Submit

December 4, 2015

Conditions

SarcoidosisPulmonary Sarcoidosis

Keywords

prednisone, methotrexate, sarcoidosis, azathioprine

Outcome Measures

Primary Outcomes (1)

  • Steroid toxicity

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

    24 weeks

Secondary Outcomes (4)

  • Forced Vital Capacity (FVC)

    24 weeks

  • Chest x-ray

    24 weeks

  • PET scan

    24 weeks

  • Sarcoidosis Health Questionnaire

    24 weeks

Study Arms (2)

80 units

ACTIVE COMPARATOR

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

Drug: Acthar gel

40 units

ACTIVE COMPARATOR

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

Drug: Acthar gel

Interventions

Acthar gelDRUG

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

Also known as: ACTH, Cortysin
40 units80 units

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28353116DERIVED

MeSH Terms

Conditions

SarcoidosisSarcoidosis, Pulmonary

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Robert P Baughman, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert P Baughman, MD

CONTACT

513-58405225bob.baughman@uc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2014

First Posted

July 11, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

September 1, 2017

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

US(1)