EDSS variability before randomization may limit treatment discovery in primary progressive MS

Multiple Sclerosis Journal

Volumn 19, Issue 6, 2013, Pages 775-781

  Zhang, Jiameng ^a   Waubant, Emmanuelle ^b   Cutter, Gary ^c   Wolinsky, Jerry S ^d   Glanzman, Robert ^e  

^a GENENTECH INC   (United States)

^b UCSF Multiple Sclerosis Center   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d UNIVERSITY OF TEXAS   (United States)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

disability progression; EDSS; Multiple sclerosis; PPMS; rituximab

Indexed keywords

PLACEBO; RITUXIMAB; IMMUNOSUPPRESSIVE AGENT; MONOCLONAL ANTIBODY;

ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; EXPANDED DISABILITY STATUS SCALE; HUMAN; MULTIPLE CYCLE TREATMENT; MULTIPLE SCLEROSIS; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY AND SPECIFICITY; SIMULATION; ADOLESCENT; ADULT; AGED; CLINICAL TRIAL; COMPUTER SIMULATION; DISABILITY; FEMALE; MALE; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; NORTH AMERICA; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; STATISTICAL MODEL; TIME; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; COMPUTER SIMULATION; DISABILITY EVALUATION; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LINEAR MODELS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; NORTH AMERICA; PREDICTIVE VALUE OF TESTS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84877621573     PISSN: 13524585     EISSN: 14770970     Source Type: Journal    
DOI: 10.1177/1352458512459685     Document Type: Article

References (16)

1. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology. 1983 ; 33: 1444-1452
2. Albrecht H, Wotzel C, Erasmus LP, et al. Day-to-day variability of maximum walking distance in MS patients can mislead to relevant changes in the Expanded Disability Status Scale (EDSS): Average walking speed is a more constant parameter. Mult Scler. 2001 ; 7: 105-109
3. Amato MP, Fratiglioni L, Groppi C, et al. Interrater reliability in assessing functional systems and disability on the Kurtzke scale in multiple sclerosis. Arch Neurol. 1988 ; 45: 746-748
4. Pickin M, Cooper CL, Chater T, et al. The Multiple Sclerosis Risk Sharing Scheme Monitoring Study - early results and lessons for the future. BMC Neurol. 2009 ; 9: 1
5. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis. Report no. CPMP/EWP/561/98 Rev. 1, http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2009/09/WC500003485.pdf (2006, accessed 31 October 2011).
6. Hawker K, O'Connor P, Freedman MS, 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
7. Cofield SS, Cutter GR, Lublin F, et al. Variability in the EDSS: What does it mean for progression?. Presented at American Academy of Neurology (AAN) ; Chicago, IL, USA ;..
8. Hauser SL, Waubant E, Arnold DL, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008 ; 358: 676-688
9. Cutter GR, Baier ML, Rudick RA, et al. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 ; 122: 871-882
10. Rudick R, Antel J, Confavreux C, et al. Recommendations from the National Multiple Sclerosis Society Clinical Outcomes Assessment Task Force. Ann Neurol. 1997 ; 42: 379-382
11. Fischer JS, Rudick RA, Cutter GR, et al. The Multiple Sclerosis Functional Composite Measure (MSFC): An integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler. 1999 ; 5: 244-250
12. Kragt JJ, van der Linden FA, Nielson JM, et al. Clinical impact of 20% worsening on Timed 25-foot Walk and 9-hole Peg Test in multiple sclerosis. Mult Scler. 2006 ; 12: 594-598
13. Schwid SR, Goodman AD, Apatoff BR, et al. Are quantitative functional measures more sensitive to worsening MS than traditional measures?. Neurology. 2000 ; 55: 1901-1903
14. Schwid SR, Goodman AD, McDermott MP, et al. Quantitative functional measures in MS: What is a reliable change?. Neurology. 2002 ; 58: 1294-1296
15. Kragt JJ, Nielsen JM, van der Linden FA, et al. Disease progression in multiple sclerosis: Combining physicians' and patients' perspectives?. Mult Scler. 2011 ; 17: 234-240
16. Zhang J, Waubant E, Cutter G, et al New Orleans, LA, USA: American Academy of Neurology (AAN) ; 2012 :