Clinical trial NCT02633033: Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
Official title: A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Relapsing-Remitting
Acthar
Corticotropin
MS
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Mallinckrodt ARD Inc.
First posted: 2015-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed description: Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)
timeFrame: at 2 months
Secondary outcomes:
measure: Physical subscale score of the MSIS-29v1 within 6 months
timeFrame: within 6 months
measure: Psychological subscale score of the MSIS-29v1 within 6 months
timeFrame: within 6 months
measure: Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS)
timeFrame: within 6 months
measure: Clinical Global Impression of Improvement Scale (CGI-I)
timeFrame: within 6 months
measure: Total score of the MSIS-29v1 within 6 months
timeFrame: within 6 months
measure: Number of participants with treatment response based on the MSIS-29v1 physical subscale score
timeFrame: within 6 months
measure: Number of participants with treatment response based on the EDSS
timeFrame: within 6 months
measure: Percent of normal work hours missed (absenteeism) due to MS exacerbation
timeFrame: within 6 months
measure: Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation
timeFrame: within 6 months
measure: Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation
timeFrame: within 6 months
measure: Number of participants with Impairment in activities other than work due to MS exacerbation
timeFrame: within 6 months
measure: Number of days per month an unpaid caregiver missed work due to the patient's MS
timeFrame: within 6 months
measure: Number of MS-related off-site clinical/office visits with a specialist or a general practitioner
timeFrame: within 6 months
measure: Number of MS-related healthcare professional visits at home
timeFrame: within 6 months
measure: Number of MS-related emergency department visits
timeFrame: within 6 months
measure: Number of MS-related hospitalizations
timeFrame: within 6 months
measure: Number of MS-related MRIs
timeFrame: within 6 months
measure: Number of days per month of MS-related paid and unpaid caregiver assistance
timeFrame: within 6 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Tucson
country: United States
facility: Territory Neurology & Research Institute
state: Arizona
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut
state: Connecticut
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
city: Lighthouse Point
country: United States
facility: Emery Neuroscience Center
state: Florida
city: Maitland
country: United States
facility: Neurology Associates
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Ocala
country: United States
facility: Florida Neurological Center
state: Florida
city: Orlando
country: United States
facility: Neurological Services of Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Sarasota
country: United States
facility: Negroski, Sutherland and Hanes Neurology
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research
state: Florida
city: Columbus
country: United States
facility: Columbus Research & Wellness Institute
state: Georgia
city: Macon
country: United States
facility: Neurology of Central Georgia
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Baltimore
country: United States
facility: University System of Maryland
state: Maryland
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute
state: Maryland
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: Hopedale
country: United States
facility: Milford Regional Medical Center
state: Massachusetts
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: New York
country: United States
facility: Strotira, Inc.
state: New York
city: Staten Island
country: United States
facility: Alpha Neurology
state: New York
city: Woodmere
country: United States
facility: Five Towns Neurology
state: New York
city: Mooresville
country: United States
facility: Braunstein Neurology
state: North Carolina
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic for Multiple Sclerosis
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Optimum Neurology
state: Pennsylvania
city: Jamison
country: United States
facility: Irene Greenhouse MD
state: Pennsylvania
city: Lititz
country: United States
facility: Neurology and Stroke Associates
state: Pennsylvania
city: West Reading
country: United States
facility: D. Gary Kolva, MD, Neurology
state: Pennsylvania
city: Sumter
country: United States
facility: Colonial Healthcare
state: South Carolina
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Richmond
country: United States
facility: Dominion Neurological Services
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Study Directo
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.