Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan

Multiple Sclerosis

Volumn 20, Issue 1, 2014, Pages 12-17

  Rudick, Richard A ^a   Larocca, Nicholas ^b   Hudson, Lynn D ^c  

^a LERNER RESEARCH INSTITUTE   (United States)

^b National Multiple Sclerosis Society   (United States)

^c Critical Path Institute   (United States)

Author keywords

disability; Outcome assessments; progressive mutiple sclerosis; regulatory science

Indexed keywords

4 AMINOPYRIDINE; ALEMTUZUMAB; BETA1A INTERFERON; DACLIZUMAB; DIRUCOTIDE; DRONABINOL; GLATIRAMER; LAQUINIMOD; METHOTREXATE; METHYLPREDNISOLONE; NATALIZUMAB; RITUXIMAB; TERIFLUNOMIDE; FAMPRIDINE; FAMPRIDINE SR; FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; UNCLASSIFIED DRUG;

CLINICAL TRIAL; CONFERENCE PAPER; CONSULTATION; FOOD AND DRUG ADMINISTRATION; HUMAN; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS OUTCOME ASSESSMENTS CONSORTIUM; OUTCOME ASSESSMENT; PUBLIC-PRIVATE PARTNERSHIP; REGISTRATION; ADVISORY COMMITTEE; CLINICAL DATA INTERCHANGE STANDARD CONSORTIUM; CLINICAL TRIAL (TOPIC); CLINICIAN REPORTED OUTCOME; CONSENSUS; DRUG EFFICACY; EUROPEAN MEDICINE AGENCY; EXPANDED DISABILITY STATUS SCALE; FATIGUE SEVERITY SCALE; HEALTH CARE ORGANIZATION; HEALTH CARE PLANNING; LOW CONTRAST LETTER ACUITY TEST; MULTIPLE SCLEROSIS FUNCTIONAL COMPOSITE; MULTIPLE SCLEROSIS OUTCOME ASSESSMENT CONSORTIUM; ORGANIZATION AND MANAGEMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYMBOL DIGIT MODALITIES TEST; UNITED STATES;

DISABILITY; OUTCOME ASSESSMENTS; PROGRESSIVE MUTIPLE SCLEROSIS; REGULATORY SCIENCE;

HEALTH CARE COALITIONS; HUMANS; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT (HEALTH CARE); UNITED STATES;

EID: 84890849900     PISSN: 13524585     EISSN: 14770970     Source Type: Journal    
DOI: 10.1177/1352458513503392     Document Type: Conference Paper

References (40)

1. Rudick RA, Schiffer RB, Herndon RM. Drug treatment of multiple sclerosis. Semin Neurol. 1987 ; 7: 150-159
2. Cohen JA, Reingold SC, Polman CH, et al. Disability outcome measures in multiple sclerosis clinical trials: Current status and future prospects. Lancet Neurol. 2012 ; 5: 467-476
3. Ontaneda D, LaRocca N, Coetzee T, et al. Revisiting the multiple sclerosis functional composite: Proceedings from the National Multiple Sclerosis Society (NMSS) Task Force on Clinical Disability Measures. Mult Scler. 2012 ; 18: 1074-1080
4. Barratt RA, Bowens SL, McCune SK, et al. The critical path initiative: Leveraging collaborations to enhance regulatory science. Clin Pharmacol Ther. 2012 ; 91: 380-383
5. U. S. Food and Drug Administration. Innovation or stagnation: Challenges and opportunity on the critical path to new medical products, www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ CriticalPathOpportunitiesReports/ucm077262.htm (2004, accessed 26 February 2013).
6. Critical Path InstituteHome Page, Accessed September 2013.http://c-path. org/
7. Benedict RHB, Walton MK. Evaluating cognitive outcome measures for MS clinical trials: What is a clinically meaningful change?. Mult Scler. 2012 ; 18: 1673-1679
8. Hobart J, Blight AR, Goodman A, et al. Timed 25-foot walk: Direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013 ; 80: 1509-1517
9. Baier ML, Cutter GR, Rudick RA, et al. Low-contrast letter acuity testing captures visual dysfunction in patients with multiple sclerosis. Neurology. 2005 ; 64: 992-995
10. Balcer LJ, Galetta SL, Calabresi PA, et al. Natalizumab reduces visual loss in patients with relapsing multiple sclerosis. Neurology. 2007 ; 68: 1299-1304
11. Rao SM A manual for the brief, repeatable battery of neuropsychological tests in multiple sclerosis. National Multiple Sclerosis Society - New York ; 1991 :
12. Chabas D, Ness J, Belman A, et al. Younger children with MS have a distinct CSF inflammatory profile at disease onset. Neurology. 2010 ; 74: 399-405
13. Pachner AR, Steiner I. The multiple sclerosis severity score (MSSS) predicts disease severity over time. J Neuro Sci. 2009 ; 278: 66-70
14. Krupp LB, LaRocca NG, Muir-Nash J, et al. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 ; 46: 1121-1123
15. Sipe JC, Knobler RL, Braheny SL, et al. A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology. 1984 ; 34: 1368-1372
16. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 ; 30: 473-483
17. Davidoff GN, Roth EJ, Haughton JS, et al. M. S. Cognitive dysfunction in spinal cord injury patients: Sensitivity of the Functional Independence Measure subscales vs neuropsychologic assessment. Arch Phys Med Rehabil. 1990 ; 71: 326-329
18. Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): A new disability measure for multiple sclerosis. Mult Scler. 1999 ; 5: 223-233
19. Clanet M, Radue EW, Kappos L, et al. A randomized, double-blind, dose-comparison study of weekly interferon beta-1a in relapsing MS. Neurology. 2002 ; 59: 1507-1517
20. Cohen JA, Imrey PB, Calabresi PA, et al. Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS. Neurology. 2009 ; 72: 535-541
21. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 ; 367: 1098-1107
22. Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 ; 367: 1087-1097
23. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol. 1996 ; 39: 285-294
24. Polman CH, O'Conner PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 ; 354: 899-910
25. Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 ; 354: 911-923
26. Lublin FD, Cofield SS, Cutter GR, et al. Randomized study combining interferon and glatiramer acetate in multiple sclerosis. Ann Neurol. 2013 ; 73: 327-340
27. Kappos L, Radue EW, O'Conner P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 ; 362: 387-401
28. Cohen JA, Barkhof JA, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 ; 362: 402-415
29. Wynn D, Kaufman M, Montalban X, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): A phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010 ; 9: 381-390
30. Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: A randomised controlled phase 3 trial. Lancet. 2012 ; 380: 1819-1828
31. Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: A randomised controlled phase 3 trial. Lancet. 2012 ; 380: 1829-1839
32. O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 ; 365: 1293-1303
33. Comi G, Jeffrey D, Kappos L, et al. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 ; 366: 1000-1009
34. Cohen JA, Cutter GR, Fischer JS, et al. Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology. 2002 ; 59: 679-687
35. Freedman MS, Bar-Or A, Oger J, et al. A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS. Neurology. 2011 ; 77: 1551-1560
36. Tur C, Montalban X, Tintore M, et al. Interferon β-1b for the treatment of primary progressive multiple sclerosis: Five-year clinical trial follow-up. Arch Neurol. 2011 ; 68: 1421-1427
37. Hawker K, O'Conner P, Freedman M, et al. Rituximab in patients with primary progressive multiple sclerosis: Results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol. 2009 ; 66: 460-471
38. Wolinsky JS, Narayana PA, O'Conner P, et al. Glatiramer acetate in primary progressive multiple sclerosis: Results of a multinational, multicenter, double-blind, placebo-controlled trial. Ann. Neurol. 2007 ; 61: 14-24
39. Zajicek J, Ball S, Wright D, et al. Effect of dronabinol on progression in progressive multiple sclerosis (CUPID): A randomised, placebo-controlled trial. Lancet Neurol. 2013 ; 12 (9). 857-65
40. Goodman AD, Brown TR, Edwards KR, et al. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 ; 68: 494-502