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Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

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ClinicalTrials.gov Identifier: NCT02258217
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
OhioHealth

Brief Summary:
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Acthar Not Applicable

Detailed Description:
We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Study Start Date : June 2014
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm
Acthar 80 units subcutaneously for five consecutive days.
Drug: Acthar
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Other Name: repository corticotropin




Primary Outcome Measures :
  1. ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living) [ Time Frame: baseline visit & follow-up after treatment ]

    Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, history of patients from the survey after treatment for the new relapse will be collected.

    The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.

    ADL scores were calculated from Part 1 (new relapse), question 3 and Part 2 (after treatment of relapse), question 5 both specifically refer to ADL;

    Scale: ADL (Activities of Daily Living) Minimum value: 0 Maximum value: 9 Higher scores indicated better functioning/ improvement.


  2. ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health) [ Time Frame: baseline visit & follow-up after treatment ]

    Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, patients completed the survey after treatment for the new relapse. The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.

    Part 1 (new relapse) & Part 2 (after treatment of new relapse), question 6 were used to calculate RSH;

    Scale: RSH (Return to previous health) Minimum value: -1 Maximum value: 10 Higher scores indicating a more complete return to previous state of health.


  3. ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores) [ Time Frame: Follow-up visit ]

    Patients completed the ARMS survey after treatment for the new relapse.The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.

    The TCS score was calculated only for the time point after treatment of relapse. It was a sum of questions 4 (symptom improvement), 5 (ADL), and 6 (return to previous state of health (RSH)) were evaluated. Scores range from 0 to 30 units, with higher scores representing greater improvement/better functioning.


  4. ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores) [ Time Frame: baseline visit & follow-up after treatment ]

    Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, patients completed the survey after treatment for the new relapse.

    The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.

    PCS was computed based on the sum of the ADL and RSH questions. The PCS was computed separately for Part 1 (new relapse) and Part 2 (after relapse treatment) and summarized descriptively; Higher scores indicating better functioning/greater improvement. The PCS scores were on a scale of 0 to 20 units.


  5. MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score [ Time Frame: baseline visit & follow-up after treatment ]

    The MSIS-29 is a self-reported questionnaire in which MS patients answer a series of 29 questions designed to capture the impact of multiple sclerosis on their life over the past 2 weeks (11). Twenty of the 29 questions assess the physical impact of MS.

    The physical impact of MS was compared between pre and post phase using paired t-tests. Each question is answered with points ranging from 1 to 5. Higher score indicates worse outcome. The total MSIS physical score ranges from 20 to 100 points with lower points indicating better impact.


  6. MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score. [ Time Frame: baseline visit & follow-up after treatment ]

    The MSIS-29 is a self-reported questionnaire in which MS patients answer a series of 29 questions designed to capture the impact of multiple sclerosis on their life over the past 2 weeks (11). Twenty of the 29 questions assess the physical impact of MS and 9 questions assess the psychological impact of MS.

    The psychological impact of MS was compared between pre and post phase using paired t-tests.

    The psychological impact of MS was compared between pre and post phase using paired t-tests.

    The score was on a scale of 9 to 45 points for MSIS psychological score.

    Higher score indicate worse outcome.


  7. EDSS (Expanded Disability Status Scale) Scores. [ Time Frame: baseline and at follow-up ]

    This scaling score is obtained by performing a neurologic exam with specific attention to eight different neurologic functional systems: visual, pyramidal, cerebellar, bowel and bladder, cerebral, brainstem, sensory and other (10). The score is rated from zero (normal neurologic examination) to ten (death due to MS). This is the standard neurologic disability scale used in clinical trials for the evaluation of disability in patients with MS.

    These scores were compared between pre and post phase using paired t-tests.


  8. SAGE (Self-administered Gerocognitive Exam) Scores [ Time Frame: baseline and follow-up ]

    The Self-Administered Gerocognitive Exam (SAGE) is designed to detect early signs of cognitive, memory or thinking impairments. It evaluates your thinking abilities and helps physicians to know how well your brain is working.

    It consists of 12 questions which are scored at different scales. The final SAGE score is calculated as a sum of these 12 questions and it ranges from 0 to 22.

    Higher score indicates better outcome.



Secondary Outcome Measures :
  1. GASE Scale Questionnaire (Generic Assessment of Side Effects) [ Time Frame: 1 week ]

    Patients who reported a history of poor corticosteroid tolerability will be placed on Acthar and GASE scale will be given to assess tolerability to Acthar.

    We listed the number of times a symptom was reported and was attributable to the ACTHAR treatment




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:   Yes
Criteria

Inclusion Criteria:

  1. Subjects who have volunteered and consented to participate in the study.
  2. Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
  3. Male or Female subjects age 18 or greater years of age.
  4. Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
  5. Subjects without an active infection (Note: If a patient is found to have an uncomplicated UTI and agrees to start on appropriate antibiotic treatment, they can continue in the study).
  6. Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
  7. Subjects who are able and willing to sign a consent form.

Exclusion Criteria:

  1. Subjects who are less than 18 years of age.
  2. Subjects with any contraindication to taking Acthar.
  3. Subjects with an active infection other than an uncomplicated urinary tract infection (UTI) (subjects determined to have a UTI who agree to be treated with appropriate antibiotics will not be excluded).
  4. Subjects with an immune deficiency.
  5. Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
  6. Subjects who are pregnant or breastfeeding.
  7. Subjects who are unable or unwilling to sign consent form.
  8. Patient is unable or unwilling to participate in phone and clinic follow up.
  9. Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.

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): NCT02258217


Locations
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United States, Ohio
OhioHealth
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Aaron L Boster, MD OhioHealth
Publications:

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Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT02258217    
Other Study ID Numbers: 2014H0156
First Posted: October 7, 2014    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: May 2019
Additional relevant MeSH terms:
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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
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs