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
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with clinically significant improvement - successful glucocorticoid tapering.