Status:

COMPLETED

CNS Sarcoidosis and Acthar Gel

Lead Sponsor:

University of Maryland, Baltimore

Collaborating Sponsors:

Mallinckrodt

Conditions:

CNS Sarcoidosis

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with...

Detailed Description

Sarcoidosis is a chronic and frequently progressive systemic disease that affects the central nervous system (CNS) in approximately 5% of patients. The hallmark of the disease is the development of ch...

Eligibility Criteria

Inclusion

  • A highly probable diagnosis of sarcoidosis, as determined using the World Association for Sarcoidosis and Other Granulomatous Disorders (WASOG) Sarcoidosis Organ Assessment Instrument (Judson et al., 2014), with involvement not limited to the central nervous system.
  • At the time of enrollment, a history of clinical deterioration based on the development of new symptoms or worsening previously present symptoms with confirmation by clinical examination and objective clinical testing.
  • If on steroids, on a stable dose of the medication for at least 3 months.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2016

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2020

    Estimated Enrollment :

    4 Patients enrolled

    Trial Details

    Trial ID

    NCT02298491

    Start Date

    May 1 2016

    End Date

    November 1 2020

    Last Update

    April 9 2021

    Active Locations (1)

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    1

    University of Maryland, Baltimore

    Baltimore, Maryland, United States, 21201