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

Summary

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

Timeline

Start

2014-06

Primary completion

2016-06-24

Completion

2016-12

Outcome

Mixed primary results

registry analysis (equivalence test); Single Arm; p = 0.003; Mean Difference (Final Values) -1.8 (95% CI -2.9 to -0.66); Paired t-test, 2 sided NCT02258217 ↗

registry MEAN Single Arm: ADL (new relapse): 3.1 (Standard Deviation 2.2) score on a scale NCT02258217 ↗

registry MEAN Single Arm: ADL (after treatment of relapse): 4.9 (Standard Deviation 2.8) score on a scale NCT02258217 ↗

registry analysis (equivalence test); Single Arm; p = 0.19; Median Difference (Final Values) 2.5; Wilcoxon Signed Rank test NCT02258217 ↗

registry analysis (equivalence test); Single Arm; p = 0.01; Mean Difference (Final Values) 3.1 (95% CI 0.74 to 5.45); Paired t-test, 2 sided NCT02258217 ↗

registry analysis (equivalence test); Single Arm; p = 0.44; Median Difference (Final Values) 0; Wilcoxon Signed Rank test NCT02258217 ↗

Publications

• 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.
• Background 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.
• Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acthar	Peptide	80 unknown	Subcutaneous

Indications