ACTHAR Therapy for Central Nervous System Sarcoidosis (NCT02920710) | Clinical Trial Compass
WithdrawnPhase 4
ACTHAR Therapy for Central Nervous System Sarcoidosis
Stopped: Difficulty with recruitment
United States0Started 2019-02-01
Plain-language summary
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
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Proportion of patients with clinically significant improvement - successful glucocorticoid tapering.