Back to resultsTolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acthar
Sponsored by
About this trial
This is an interventional other trial for Relapsing Remitting Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Subjects who have volunteered and consented to participate in the study.
- Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
- Male or Female subjects age 18 or greater years of age.
- Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
- 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).
- Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
- Subjects who are able and willing to sign a consent form.
Exclusion Criteria:
- Subjects who are less than 18 years of age.
- Subjects with any contraindication to taking Acthar.
- 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).
- Subjects with an immune deficiency.
- Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
- Subjects who are pregnant or breastfeeding.
- Subjects who are unable or unwilling to sign consent form.
- Patient is unable or unwilling to participate in phone and clinic follow up.
- Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.
Sites / Locations
- OhioHealth
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Acthar 80 units subcutaneously for five consecutive days.
Outcomes
Primary Outcome Measures
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
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.
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
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.
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
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.
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
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.
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
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.
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
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.
EDSS (Expanded Disability Status Scale) Scores.
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.
SAGE (Self-administered Gerocognitive Exam) Scores
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
GASE Scale Questionnaire (Generic Assessment of Side Effects)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02258217
Brief Title
Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
Official Title
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 24, 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OhioHealth
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Acthar 80 units subcutaneously for five consecutive days.
Intervention Type
Drug
Intervention Name(s)
Acthar
Other Intervention Name(s)
repository corticotropin
Intervention Description
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Primary Outcome Measure Information:
Title
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
Description
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.
Time Frame
baseline visit & follow-up after treatment
Title
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
Description
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.
Time Frame
baseline visit & follow-up after treatment
Title
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
Description
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.
Time Frame
Follow-up visit
Title
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
Description
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.
Time Frame
baseline visit & follow-up after treatment
Title
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
Description
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.
Time Frame
baseline visit & follow-up after treatment
Title
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
Description
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.
Time Frame
baseline visit & follow-up after treatment
Title
EDSS (Expanded Disability Status Scale) Scores.
Description
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.
Time Frame
baseline and at follow-up
Title
SAGE (Self-administered Gerocognitive Exam) Scores
Description
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.
Time Frame
baseline and follow-up
Secondary Outcome Measure Information:
Title
GASE Scale Questionnaire (Generic Assessment of Side Effects)
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who have volunteered and consented to participate in the study.
Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
Male or Female subjects age 18 or greater years of age.
Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
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).
Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
Subjects who are able and willing to sign a consent form.
Exclusion Criteria:
Subjects who are less than 18 years of age.
Subjects with any contraindication to taking Acthar.
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).
Subjects with an immune deficiency.
Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
Subjects who are pregnant or breastfeeding.
Subjects who are unable or unwilling to sign consent form.
Patient is unable or unwilling to participate in phone and clinic follow up.
Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron L Boster, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
12. IPD Sharing Statement
Citations:
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16444920
Citation
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Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.
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O'Brien JA, Ward AJ, Patrick AR, Caro J. Cost of managing an episode of relapse in multiple sclerosis in the United States. BMC Health Serv Res. 2003 Sep 2;3(1):17. doi: 10.1186/1472-6963-3-17.
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Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
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