Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

NCT02633033 | Completed

• 1 other identifier: MNK14130050
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 38

Brief Summary

Acthar Gel was first approved by the Food and Drug Administration in 1952. 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting; Acthar; Corticotropin; MS

Outcome Measures

Primary Outcomes (1)

• Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)

  Participants rate 20 physical symptoms of multiple sclerosis (MS) on a scale from 1=not at all to 5=extremely. The highest possible score is 100. Higher scores mean physical symptoms of MS have a higher impact on day-to-day life. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  at 2 months

Secondary Outcomes (18)

• Physical subscale score of the MSIS-29v1 within 6 months

  within 6 months

• Psychological subscale score of the MSIS-29v1 within 6 months

  within 6 months

• Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS)

  within 6 months

• Clinical Global Impression of Improvement Scale (CGI-I)

  within 6 months

• Total score of the MSIS-29v1 within 6 months

  within 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a relapsing form of MS who initiate treatment with Acthar Gel for an MS exacerbation

You may qualify if:

• Male or Female ≥ 18 years of age.
• Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
• Patient with an acute MS exacerbation as determined by their treating clinician.
• Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
• Patient capable of providing informed consent.

You may not qualify if:

• Patients with a diagnosis of Progressive MS.
• Patients that require concomitant corticosteroid therapy.
• Patients receiving experimental drug therapy.
• Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
• 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.
• 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.
• If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.

Sponsors & Collaborators

• Mallinckrodt: lead
• Mallinckrodt ARD Inc.: collaborator

Study Sites (38)

Alabama Neurology Associates

Homewood, Alabama, 35209, United States

Location

Territory Neurology & Research Institute

Tucson, Arizona, 85704, United States

Location

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

Advanced Neurosciences Research

Fort Collins, Colorado, 80528, United States

Location

Associated Neurologists of Southern Connecticut

Fairfield, Connecticut, 06824, United States

Location

MedStar Health

Washington D.C., District of Columbia, 20007, United States

Location

Emery Neuroscience Center

Lighthouse PT, Florida, 33064, United States

Location

Neurology Associates

Maitland, Florida, 32751, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

Florida Neurological Center

Ocala, Florida, 34471, United States

Location

Neurological Services of Orlando

Orlando, Florida, 32806, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Negroski, Sutherland and Hanes Neurology

Sarasota, Florida, 34239, United States

Location

Infinity Clinical Research

Sunrise, Florida, 33351, United States

Location

Columbus Research & Wellness Institute

Columbus, Georgia, 31904, United States

Location

Neurology of Central Georgia

Macon, Georgia, 31210, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66212, United States

Location

University System of Maryland

Baltimore, Maryland, 21201, United States

Location

International Neurorehabilitation Institute

Lutherville, Maryland, 21093, United States

Location

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Location

Milford Regional Medical Center

Hopedale, Massachusetts, 01747, United States

Location

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Strotira, Inc.

New York, New York, 11714, United States

Location

Alpha Neurology

Staten Island, New York, 10306, United States

Location

Five Towns Neurology

Woodmere, New York, 11598, United States

Location

Braunstein Neurology

Mooresville, North Carolina, 28117, United States

Location

The Toledo Clinic

Toledo, Ohio, 43623, United States

Location

Oak Clinic for Multiple Sclerosis

Uniontown, Ohio, 44685, United States

Location

Optimum Neurology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Irene Greenhouse MD

Jamison, Pennsylvania, 18929, United States

Location

Neurology and Stroke Associates

Lititz, Pennsylvania, 17543, United States

Location

D. Gary Kolva, MD, Neurology

West Reading, Pennsylvania, 19610, United States

Location

Colonial Healthcare

Sumter, South Carolina, 29150, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Dominion Neurological Services

Richmond, Virginia, 23226, United States

Location

Related Publications (2)

• 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.

  PMID: 34860120 DERIVED

• 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.

  PMID: 33414758 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Study Directo

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: November 24, 2015
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)