Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
NCT ID: NCT02258217
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single arm
Acthar 80 units subcutaneously for five consecutive days.
Acthar
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Interventions
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Acthar
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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OhioHealth
OTHER
Responsible Party
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Principal Investigators
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Aaron L Boster, MD
Role: PRINCIPAL_INVESTIGATOR
OhioHealth
Locations
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OhioHealth
Columbus, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001 May;124(Pt 5):962-73. doi: 10.1093/brain/124.5.962.
Perrin Ross A, Williamson A, Smrtka J, Flemming Tracy T, Saunders C, Easterling C, Niewoehner J, Mutschler N. Assessing relapse in multiple sclerosis questionnaire: results of a pilot study. Mult Scler Int. 2013;2013:470476. doi: 10.1155/2013/470476. Epub 2013 May 26.
Other Identifiers
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2014H0156
Identifier Type: -
Identifier Source: org_study_id
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