Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Alabama Neurology Associates
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Territory Neurology & Research Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Health
  • Florida
    • Lighthouse Point, Florida, United States, 33064
      • Emery Neuroscience Center
    • Maitland, Florida, United States, 32751
      • Neurology Associates
    • Miami, Florida, United States, 33155
      • Cordova Research Institute
    • Naples, Florida, United States, 34102
      • Collier Neurologic Specialists
    • Ocala, Florida, United States, 34471
      • Florida Neurological Center
    • Orlando, Florida, United States, 32806
      • Neurological Services of Orlando
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Sarasota, Florida, United States, 34239
      • Negroski, Sutherland and Hanes Neurology
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Research & Wellness Institute
    • Macon, Georgia, United States, 31210
      • Neurology of Central Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University System of Maryland
    • Lutherville, Maryland, United States, 21093
      • International Neurorehabilitation Institute
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of New England
    • Hopedale, Massachusetts, United States, 01747
      • Milford Regional Medical Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • CentraState Medical Center
  • New York
    • New York, New York, United States, 11714
      • Strotira, Inc.
    • Staten Island, New York, United States, 10306
      • Alpha Neurology
    • Woodmere, New York, United States, 11598
      • Five Towns Neurology
  • North Carolina
    • Mooresville, North Carolina, United States, 28117
      • Braunstein Neurology
  • Ohio
    • Toledo, Ohio, United States, 43623
      • The Toledo Clinic
    • Uniontown, Ohio, United States, 44685
      • Oak Clinic for Multiple Sclerosis
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Optimum Neurology
    • Jamison, Pennsylvania, United States, 18929
      • Irene Greenhouse MD
    • Lititz, Pennsylvania, United States, 17543
      • Neurology and Stroke Associates
    • West Reading, Pennsylvania, United States, 19610
      • D. Gary Kolva, MD, Neurology
  • South Carolina
    • Sumter, South Carolina, United States, 29150
      • Colonial Healthcare
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden Clinic
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Dominion Neurological Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical subscale score of the MSIS-29v1 within 6 months	Participants rate 20 physical symptoms of 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). Rows: at 2 weeks, at 1 Month, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Psychological subscale score of the MSIS-29v1 within 6 months	Participants rate 9 psychological symptoms of MS on a scale from 1=not at all to 5=extremely. The highest possible score is 45. Higher scores mean psychological 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). Rows: at 2 weeks, at 1 Month, at 2 months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS)	Treating clinicians trained in completing the EDSS/FSS (neurologist or other healthcare professional such as a nurse practitioner or physician assistant) complete the EDSS/FSS to evaluate patient neurologic impairment. The EDSS is based on the standard neurological examination and is used by the clinician in conjunction with the Functional System Score (FSS) to produce a disability score. The FSS is a companion scale that is part of the EDSS Expanded Disability Status Scale (EDSS) is a well validated 10 point ordinal clinical rating scale with scores ranging from 0 (normal neurological examination) to 10 (death due to MS) in 0.5 point increments. The highest possible score is 100. A higher score means more neurological disability. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at Baseline, at 2 Months, at 6 Months	within 6 months
Clinical Global Impression of Improvement Scale (CGI-I)	Treating clinicians complete the CGI-I. It is a scale that compares the overall condition of the patient to baseline. Scores range from 1 (very much improved) to 7 (very much worse). The highest possible score is 7. Lower scores mean improvement. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at Baseline, at 2 Months, at 6 Months	within 6 months
Total score of the MSIS-29v1 within 6 months	Participants rate 29 psychological symptoms of MS on a scale from 1=not at all to 5=extremely. The highest possible score is 145. Higher scores mean total 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). Rows: at 2 weeks, at 1 Month, at 2 months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Number of participants with treatment response based on the MSIS-29v1 physical subscale score	Treatment response is defined as an 8-point improvement on the MSIS-29v1 physical subscale score at 2 weeks and 1, 2, 3, 4, 5 and 6 months. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of participants with treatment response based on the EDSS	Treatment response is defined as a 0.5 point improvement on the EDSS at 2 and 6 months. For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at 2 Months, at 6 Months	within 6 months
Percent of normal work hours missed (absenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at 2 weeks, at 1 Month, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Number of participants with Impairment in activities other than work due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s). Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Number of days per month an unpaid caregiver missed work due to the patient's MS	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of MS-related off-site clinical/office visits with a specialist or a general practitioner	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of MS-related healthcare professional visits at home	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of MS-related emergency department visits	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of MS-related hospitalizations	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of MS-related MRIs	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Number of days per month of MS-related paid and unpaid caregiver assistance	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months

Collaborators and Investigators

• Sponsor: Mallinckrodt
• Collaborators: Mallinckrodt ARD Inc.
• Investigators: Study Director: Study Directo, Mallinckrodt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2015
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; MS; Relapsing-Remitting; Corticotropin; Acthar
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: MNK14130050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO