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NCT Number: NCT02633033

Observational Registry of Acthar Gel for Participants With 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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alabama Neurology Associates, Homewood, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: at 2 months

    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).

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: within 6 months

    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

  4. Clinical Global Impression of Improvement Scale (CGI-I)

    Time frame: within 6 months

    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

  5. Total score of the MSIS-29v1 within 6 months

    Time frame: 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

  6. Number of participants with treatment response based on the MSIS-29v1 physical subscale score

    Time frame: within 6 months

    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).

  7. Number of participants with treatment response based on the EDSS

    Time frame: within 6 months

    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

  8. Percent of normal work hours missed (absenteeism) due to MS exacerbation

    Time frame: within 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 weeks, at 1 Month, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months

  9. Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation

    Time frame: within 6 months

    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

  10. Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation

    Time frame: within 6 months

    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

  11. Number of participants with Impairment in activities other than work due to MS exacerbation

    Time frame: within 6 months

    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

  12. Number of days per month an unpaid caregiver missed work due to the patient's MS

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  13. Number of MS-related off-site clinical/office visits with a specialist or a general practitioner

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  14. Number of MS-related healthcare professional visits at home

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  15. Number of MS-related emergency department visits

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  16. Number of MS-related hospitalizations

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  17. Number of MS-related MRIs

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

  18. Number of days per month of MS-related paid and unpaid caregiver assistance

    Time frame: within 6 months

    For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Collaborators

  • Mallinckrodt ARD Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2015
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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