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Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

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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

Tracking Information
First Submitted Date December 15, 2015
First Posted Date December 17, 2015
Last Update Posted Date December 9, 2019
Actual Study Start Date November 24, 2015
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2019)
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).
Original Primary Outcome Measures
 (submitted: December 15, 2015)
Multiple Sclerosis Impact Scale version 1 (MSIS-29v1) [ Time Frame: 6 months post exacerbation ]
Evaluates the physical and psychological impact of MS
Change History
Current Secondary Outcome Measures
 (submitted: December 5, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
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
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Kaplan J, Miller T, Baker M, Due B, Zhao E. A Prospective Observational Registry of Repository Corticotropin Injection (Acthar® Gel) for the Treatment of Multiple Sclerosis Relapse. Front Neurol. 2020 Dec 22;11:598496. doi: 10.3389/fneur.2020.598496. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2018)
160
Original Estimated Enrollment
 (submitted: December 15, 2015)
260
Actual Study Completion Date May 9, 2019
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number NCT02633033
Other Study ID Numbers MNK14130050
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mallinckrodt
Study Sponsor Mallinckrodt
Collaborators Mallinckrodt ARD Inc.
Investigators
Study Director: Study Directo Mallinckrodt
PRS Account Mallinckrodt
Verification Date December 2019