Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis Relapse



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:November 24, 2015
End Date:May 2019

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A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse

This observational study aims to characterize the patient population and describe multiple
sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with
multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in
standard practice in the United States.

H.P. Acthar Gel (repository corticotropin injection) contains a porcine analogue of
adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use. H.P. Acthar Gel
(Acthar Gel) was initially approved by the FDA in 1952 and has multiple indications of use.
This registry will evaluate the use of Acthar Gel for the treatment of exacerbations of
multiple sclerosis (MS) in the US.

Inclusion Criteria:

1. Male or Female ≥ 18 years of age.

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:

1. Patients with a diagnosis of Progressive MS.

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.
We found this trial at
41
sites
Overland Park, Kansas 66210
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Overland Park, KS
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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Ormond Beach, FL
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5090 N 40th St # 250
Phoenix, Arizona 85018
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Phoenix, AZ
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301 East City Avenue
Bala-Cynwyd, Pennsylvania 19004
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Bala-Cynwyd, PA
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620 West Lexington Street
Baltimore, Maryland 21201
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Baltimore, MD
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150 55th Street
Brooklyn, New York 11220
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Brooklyn, NY
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Centerville, OH
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Columbus, Georgia 31909
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Columbus, GA
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Fairfield, CT
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Fort Collins, Colorado 80528
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Fort Collins, CO
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16 Chestnut Street
Foxboro, Massachusetts 02035
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Foxboro, MA
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Freehold, New Jersey 07728
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Freehold, NJ
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Homewood, Alabama 35209
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Homewood, AL
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115 Water Street
Hopedale, Massachusetts 01747
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Hopedale, MA
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2370 York Road
Jamison, Pennsylvania 18929
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Jamison, PA
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5340 North Federal Highway
Lighthouse Point, Florida 33064
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Lighthouse Point, FL
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640 East Oregon Road
Lititz, Pennsylvania 17543
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Lititz, PA
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1300 York Road
Lutherville, Maryland 21093
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Lutherville, MD
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Macon, Georgia 31210
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Macon, GA
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Maitland, Florida 32751
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Maitland, FL
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Miami, Florida 33155
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Miami, FL
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124 Professional Park Drive
Mooresville, North Carolina 28117
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Mooresville, NC
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Naples, Florida 34102
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Naples, FL
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New York, New York 11714
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New York, NY
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2237 Southwest 19th Avenue Road
Ocala, Florida 34471
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Ocala, FL
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Ogden, Utah 84403
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Ogden, UT
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Orlando, Florida 32806
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Orlando, FL
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1601 Rolling Hills Drive
Richmond, Virginia 23226
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Richmond, VA
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Sarasota, Florida 34239
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Sarasota, FL
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Savannah, Georgia 31406
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Savannah, GA
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27 New Dorp Lane
Staten Island, New York 10306
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Staten Island, NY
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325 Broad Street
Sumter, South Carolina 29150
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Sumter, SC
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Sunrise, Florida 33351
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Sunrise, FL
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Toledo, Ohio 43623
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Toledo, OH
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Tucson, AZ
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Uniontown, Ohio 44685
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Uniontown, OH
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110 Irving Street Northwest
Washington, District of Columbia 20010
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Washington,
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301 South 7th Avenue
West Reading, Pennsylvania 19610
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West Reading, PA
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923 Broadway
Woodmere, New York 11598
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Woodmere, NY
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