Tolerability of Acthar for the Treatment of Multiple Sclerosis in Rela
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
Results by group
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
baseline visit & follow-up after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 3.1 score on a scale | 2.2 (Standard Deviation) | 30 |
| Single Arm | 4.9 score on a scale | 2.8 (Standard Deviation) | 30 |
Single Arm
Single Arm
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
baseline visit & follow-up after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 4.6 score on a scale | 2.9 (Standard Deviation) | 27 |
| Single Arm | 4.4 score on a scale | 3.2 (Standard Deviation) | 27 |
Single Arm
Single Arm
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
Follow-up visit
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 14.3 score on a scale | 8.5 (Standard Deviation) | 29 |
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
baseline visit & follow-up after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 7.7 score on a scale | 3.3 (Standard Deviation) | 27 |
| Single Arm | 9.2 score on a scale | 5.6 (Standard Deviation) | 27 |
Single Arm
Single Arm
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
baseline visit & follow-up after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 58.5 score on a scale | 23–90 | 30 |
| Single Arm | 56 score on a scale | 20–91 | 30 |
Single Arm
Single Arm
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
baseline visit & follow-up after treatment
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 29.4 score on a scale | 12–45 | 30 |
| Single Arm | 26.3 score on a scale | 9–45 | 30 |
Single Arm
Single Arm
EDSS (Expanded Disability Status Scale) Scores.
baseline and at follow-up
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 3.5 score on a scale | 0–8 | 13 |
| Single Arm | 3.0 score on a scale | 0–7.5 | 13 |
Single Arm
Single Arm
SAGE (Self-administered Gerocognitive Exam) Scores
baseline and follow-up
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Single Arm | 21 score on a scale | 14–22 | 25 |
| Single Arm | 21 score on a scale | 15–22 | 25 |
Single Arm
Single Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Single Arm | 30 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
baseline visit & follow-up after treatment
RelapsesSafetyARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
baseline visit & follow-up after treatment
RelapsesSafetyARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
Follow-up visit
RelapsesSafetyARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
baseline visit & follow-up after treatment
RelapsesSafetyMSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
baseline visit & follow-up after treatment
Quality of life (reported by participants)MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
baseline visit & follow-up after treatment
Quality of life (reported by participants)EDSS (Expanded Disability Status Scale) Scores.
baseline and at follow-up
Disability progressionThinking and memoryBladder, bowel and sexual functionSAGE (Self-administered Gerocognitive Exam) Scores
baseline and follow-up
Thinking and memory
Other measures (1)
GASE Scale Questionnaire (Generic Assessment of Side Effects)
1 week
Safety
Who could take part
Relapsing MS · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Papers
Background
Fox RJ, Bethoux F, Goldman MD, Cohen JA. Multiple sclerosis: advances in understanding, diagnosing, and treating the underlying disease. Cleve Clin J Med. 2006 Jan;73(1):91-102. doi: 10.3949/ccjm.73.1.91.Background
Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907.Background
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.Background
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.Background
Barnes D, Hughes RA, Morris RW, Wade-Jones O, Brown P, Britton T, Francis DA, Perkin GD, Rudge P, Swash M, Katifi H, Farmer S, Frankel J. Randomised trial of oral and intravenous methylprednisolone in acute relapses of multiple sclerosis. Lancet. 1997 Mar 29;349(9056):902-6. doi: 10.1016/s0140-6736(96)06453-7.Background
Morrow SA, Stoian CA, Dmitrovic J, Chan SC, Metz LM. The bioavailability of IV methylprednisolone and oral prednisone in multiple sclerosis. Neurology. 2004 Sep 28;63(6):1079-80. doi: 10.1212/01.wnl.0000138572.82125.f5.Background
La Mantia L, Eoli M, Milanese C, Salmaggi A, Dufour A, Torri V. Double-blind trial of dexamethasone versus methylprednisolone in multiple sclerosis acute relapses. Eur Neurol. 1994;34(4):199-203. doi: 10.1159/000117038.Background
Burton JM, O'Connor PW, Hohol M, Beyene J. Oral versus intravenous steroids for treatment of relapses in multiple sclerosis. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD006921. doi: 10.1002/14651858.CD006921.pub3.Background
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.Background
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
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History
Started
Jun 2014
Main results due
Jun 2016
Finished
Dec 2016
Results posted
Sept 2020