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Trial · Interventional

WithdrawnPhase 4Registry data

ACTHAR Therapy for Central Nervous System Sarcoidosis

NCTNCT02920710 (opens ClinicalTrials.gov in a new tab)Other idACTHAR CNS
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Feb 2019
Primary completion
2 Nov 2020
Completion
2 Nov 2020
First posted
30 Sept 2016 (estimated)
Last update posted
20 Nov 2020
Conditions
Sarcoidosis

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 4

    ACTHAR Therapy for Central Nervous System Sarcoidosis

    NCT02920710

    1 Feb 2019 to 2 Nov 2020

    Withdrawn

Registry summary

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

There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information about its safety and tolerability

Interventions

  • Repository Corticotropin InjectionDrug

Arms1

  • Experimental

    Experimental: H.P. Achtar Gel 80 U

    H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 48 weeks on therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of patients with clinically significant improvement - successful glucocorticoid tapering.

    Time frame · 12 Weeks

Secondary outcomes(1)

  1. Proportion of patients with clinically significant improvement - no need for escalation of other therapy.

    Time frame · 12 Weeks

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patient with sarcoidosis as defined by ATS/ERS/WASOG (American Thoracic Society/European Thoracic Society/World Association for Sarcoidosis and Other Granulomatous Disorders) * Stable baseline immunosuppressive medications * Moderate to severe disease as defined by at least one of the following criteria: * Cranial nerve palsy * Neurologic deficits related to intraparenchymal brain, spinal cord and/or cauda equina involvement * Dural or leptomeningeal involvement of brain and/or spinal cord * Hydrocephalus * Seizures Exclusion Criteria: * Diagnosis of any underlying neurologic disorder that would potentially confound interpretation of the study results * Significant change in corticosteroid dose within the past 4 weeks, or other immunosuppressive medication within the past 6 months * Evidence of current serious infection, or a history of chronic or recurring infections. * Contraindication to high-dose corticosteroids (e.g. uncontrolled blood sugar). * Allergies to pig-derived proteins * Have a history of any opportunistic infection within 6 months prior to screening * History of malignancy.

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