Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
NCT ID: NCT02633033
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2015-11-24
2019-05-09
Brief Summary
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It has been used to treat many different illnesses, including multiple sclerosis.
This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.
It will collect information on symptoms, recovery, treatment patterns and safety outcomes.
Detailed Description
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It was initially approved by the FDA in 1952 and is used for multiple indications.
This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
3. Patient with an acute MS exacerbation as determined by their treating clinician.
4. Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
5. Patient capable of providing informed consent.
Exclusion Criteria
2. Patients that require concomitant corticosteroid therapy.
3. Patients receiving experimental drug therapy.
4. Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
5. Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
6. Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.
7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.
18 Years
ALL
No
Sponsors
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Mallinckrodt ARD Inc.
UNKNOWN
Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Study Directo
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Alabama Neurology Associates
Homewood, Alabama, United States
Territory Neurology & Research Institute
Tucson, Arizona, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Advanced Neurosciences Research
Fort Collins, Colorado, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
MedStar Health
Washington D.C., District of Columbia, United States
Emery Neuroscience Center
Lighthouse PT, Florida, United States
Neurology Associates
Maitland, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Florida Neurological Center
Ocala, Florida, United States
Neurological Services of Orlando
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Negroski, Sutherland and Hanes Neurology
Sarasota, Florida, United States
Infinity Clinical Research
Sunrise, Florida, United States
Columbus Research & Wellness Institute
Columbus, Georgia, United States
Neurology of Central Georgia
Macon, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
College Park Family Care Center
Overland Park, Kansas, United States
University System of Maryland
Baltimore, Maryland, United States
International Neurorehabilitation Institute
Lutherville, Maryland, United States
Neurology Center of New England
Foxborough, Massachusetts, United States
Milford Regional Medical Center
Hopedale, Massachusetts, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
CentraState Medical Center
Freehold, New Jersey, United States
Strotira, Inc.
New York, New York, United States
Alpha Neurology
Staten Island, New York, United States
Five Towns Neurology
Woodmere, New York, United States
Braunstein Neurology
Mooresville, North Carolina, United States
The Toledo Clinic
Toledo, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
Optimum Neurology
Bala-Cynwyd, Pennsylvania, United States
Irene Greenhouse MD
Jamison, Pennsylvania, United States
Neurology and Stroke Associates
Lititz, Pennsylvania, United States
D. Gary Kolva, MD, Neurology
West Reading, Pennsylvania, United States
Colonial Healthcare
Sumter, South Carolina, United States
Ogden Clinic
Ogden, Utah, United States
Dominion Neurological Services
Richmond, Virginia, United States
Countries
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References
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Kaplan J, Miller T, Baker M, Due B, Zhao E. Repository corticotropin injection improves quality metrics in an observational study of multiple sclerosis relapse. Neurodegener Dis Manag. 2021 Dec;11(6):469-476. doi: 10.2217/nmt-2021-0030. Epub 2021 Dec 3.
Kaplan J, Miller T, Baker M, Due B, Zhao E. A Prospective Observational Registry of Repository Corticotropin Injection (Acthar(R) Gel) for the Treatment of Multiple Sclerosis Relapse. Front Neurol. 2020 Dec 22;11:598496. doi: 10.3389/fneur.2020.598496. eCollection 2020.
Other Identifiers
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MNK14130050
Identifier Type: -
Identifier Source: org_study_id