Impact of Acthar on Everyday Life of Participants With Severe Keratitis
NCT ID: NCT04169061
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2019-11-13
2020-12-07
Brief Summary
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Volunteers might be able to participate if:
* they have bad noninfectious keratitis
* early treatments failed or were not well tolerated
Participants will be in the study for about 22 weeks:
* 4 weeks for tests to see if the study might be good for them
* 12 weeks of treatment with Acthar gel
* 4 weeks to wean off Acthar gel and follow-up with the doctor
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All participants
Participants receive:
* a shot of Acthar (80 units) under the skin twice a week for 12 weeks
* a shot of Acthar (40 units) twice a week for 2 weeks
* a shot of Acthar (40 units) once a week for 2 more weeks
At each visit they will have medical tests and answer questions about their symptoms.
Acthar
Acthar gel for subcutaneous injection
Interventions
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Acthar
Acthar gel for subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
* If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
* Has normal eyelids, and protocol-defined physical and medical eye attributes
* Agrees to avoid wearing contact lenses during the trial
Exclusion Criteria
* Is defined as vulnerable, or is employed by, or related to anyone involved in the study
* Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Global Research Management, Inc.
Glendale, California, United States
Eye Research Foundation
Newport Beach, California, United States
Eye Care Institute
Louisville, Kentucky, United States
Andover Eye Associates
Raynham, Massachusetts, United States
Vita Eye Clinic
Shelby, North Carolina, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Advancing Vision Research, LLC
Nashville, Tennessee, United States
Countries
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References
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Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MNK14084113
Identifier Type: -
Identifier Source: org_study_id
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