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Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633033
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Mallinckrodt ARD Inc.
Information provided by (Responsible Party):
Mallinckrodt

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.


Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
Actual Study Start Date : November 24, 2015
Actual Primary Completion Date : May 9, 2019
Actual Study Completion Date : May 9, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633033


Locations
Show Show 38 study locations
Sponsors and Collaborators
Mallinckrodt
Mallinckrodt ARD Inc.
Investigators
Layout table for investigator information
Study Director: Study Directo Mallinckrodt
Additional Information:

Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02633033    
Other Study ID Numbers: MNK14130050
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt:
Multiple Sclerosis
Relapsing-Remitting
Acthar
Corticotropin
MS
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases