Primary outcomeMean· baseline visit & follow-up after treatment
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Single Arm | 3.1 | 2.2 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataTolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
NCTNCT02258217 (opens ClinicalTrials.gov in a new tab)Other id2014H0156
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 30 participants (actual)
- Sponsor
- OhioHealth · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Jun 2014
- Primary completion
- 24 Jun 2016
- Completion
- Dec 2016
- First posted
- 7 Oct 2014 (estimated)
- Last update posted
- 1 Sept 2020
- Conditions
- Relapsing Remitting Multiple Sclerosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017
- N/A
Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
NCT02258217Jun 2014 to Dec 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Interventions
- ActharDrug
Arms1
Experimental
Single arm
Acthar 80 units subcutaneously for five consecutive days.
Primary outcomes8
Outcomes the sponsor listed as primary.
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
Time frame · baseline visit & follow-up after treatment
Registry 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.
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
Time frame · baseline visit & follow-up after treatment
Registry 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.
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
Time frame · Follow-up visit
Registry 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.
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
Time frame · baseline visit & follow-up after treatment
Registry 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.
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
Time frame · baseline visit & follow-up after treatment
Registry 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.
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
Time frame · baseline visit & follow-up after treatment
Registry 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.
EDSS (Expanded Disability Status Scale) Scores.
Time frame · baseline and at follow-up
Registry 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.
SAGE (Self-administered Gerocognitive Exam) Scores
Time frame · baseline and follow-up
Registry 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.
Secondary outcomes(1)
GASE Scale Questionnaire (Generic Assessment of Side Effects)
Time frame · 1 week
Registry 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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· baseline visit & follow-up after treatment
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Single Arm | 4.6 | 2.9 |
Primary outcomeMean· Follow-up visit
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Single Arm | 14.3 | 8.5 |
Primary outcomeMean· baseline visit & follow-up after treatment
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Single Arm | 7.7 | 3.3 |
Primary outcomeMedian· baseline visit & follow-up after treatment
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
| Group | Value (score on a scale) |
|---|---|
| Single Arm | 58.5 |
Primary outcomeMean· baseline visit & follow-up after treatment
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
| Group | Value (score on a scale) |
|---|---|
| Single Arm | 29.4 |
Primary outcomeMedian· baseline and at follow-up
EDSS (Expanded Disability Status Scale) Scores.
| Group | Value (score on a scale) |
|---|---|
| Single Arm | 3.5 |
Primary outcomeMedian· baseline and follow-up
SAGE (Self-administered Gerocognitive Exam) Scores
| Group | Value (score on a scale) |
|---|---|
| Single Arm | 21 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Single ArmActhar 80 units subcutaneously for five consecutive days. Acthar: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. | 0 / 30 | 0 / 30 | 0 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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.
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