Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 374, Issue 9700, 2009, Pages 1503-1511

  Comi, G ^a   Martinelli, V ^a   Rodegher, M ^a   Moiola, L ^a   Bajenaru, O ^c   Carra, A ^d   Elovaara, I ^e   Fazekas, F ^f   Hartung, HP ^g   Hillert, J ^h   King, J ⁱ   Komoly, S ^j   Lubetzki, C ^k   Montalban, X ^m   Myhr, KM ^l   Ravnborg, M ⁿ   Rieckmann, P ^o   Wynn, D ^p   Young, C ^q   Filippi, M ^b  

^a VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^b Division of Neuroscience   (Italy)

^c CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^d HOSPITAL BRITÁNICO DE BUENOS AIRES   (Argentina)

^e TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^f MEDICAL UNIVERSITY OF GRAZ   (Austria)

^g HEINRICH HEINE UNIVERSITY   (Germany)

^h KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

ⁱ ROYAL MELBOURNE HOSPITAL   (Australia)

^j UNIVERSITY OF PÉCS   (Hungary)

^k PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^l HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^m HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

ⁿ Mental Health Services CPH   (Denmark)

^o UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^p Neurology Department   (United States)

^q WALTON CENTRE FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GLATIRAMER; METHYLPREDNISOLONE; PLACEBO;

ADULT; ARTICLE; BLURRED VISION; BRAIN DAMAGE; BRAIN SIZE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG WITHDRAWAL; EARLY INTERVENTION; ERYTHEMA; FEMALE; FLU LIKE SYNDROME; HAZARD RATIO; HUMAN; INJECTION SITE ATROPHY; INJECTION SITE LIPOATROPHY; INJECTION SITE NECROSIS; INJECTION SITE REACTION; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RISK REDUCTION; SIDE EFFECT; SUICIDE; TREATMENT DURATION; URTICARIA; VOMITING;

EID: 70350786389     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(09)61259-9     Document Type: Article

References (27)

1. Thrower B.W. Clinically isolated syndromes. Predicting and delaying multiple sclerosis. Neurology 68 (2007) S12-S15
2. Polman C.H., Reingold S.C., Edan G., et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald" criteria. Ann Neurol 58 (2005) 840-846
3. Miller D., Barkhof F., Montalban X., Thompson A., and Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history, pathogenesis, diagnosis, and prognosis. Lancet Neurol 4 (2005) 281-288
4. Miller D., Barkhof F., Montalban X., Thompson A., and Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis, part 2: non-conventional MRI, recovery processes, and management. Lancet Neurol 4 (2005) 341-348
5. Trapp B.D., Peterson J., Ransohoff R.M., Rudick R., Mörk S., and Bö L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med 338 (1998) 278-285
6. Kuhlmann T., Lingfeld G., Bitsch A., Schuchardt J., and Brück W. Acute axonal damage in multiple sclerosis is most extensive in early disease stages and decreases over time. Brain 125 (2002) 2202-2212
7. Paolillo A., Piattella M.C., Pantano P., et al. The relationship between inflammation and atrophy in clinically isolated syndromes suggestive of multiple sclerosis: a monthly MRI study after triple-dose gadolinium-DTPA. J Neurol 251 (2004) 432-439
8. Filippi M., Rocca M.A., Mezzapesa D.M., et al. Simple and complex movement-associated functional MRI changes in patients at presentation with clinically isolated syndromes suggestive of multiple sclerosis. Hum Brain Mapp 21 (2004) 108-117
9. Comi G. Future Therapies in multiple sclerosis. Early treatment. Neurol Sci 27 (2006) S8-S12
10. Hohlfeld R., Kerschensteiner M., Stadelmann C., Lassmann H., and Wekerle H. The neuroprotective effect of inflammation: implications for the therapy of multiple sclerosis. J Neuroimmunol 107 (2000) 161-166
11. De Stefano N., Narayanan S., Francis G.S., et al. Evidence of axonal damage in the early stages of multiple sclerosis and itsrelevance to disability. Arch Neurol 58 (2001) 65-70
12. The National MS Society (USA). The disease-modifying drugs brochure (March 9, 2009). http://www.nationalmssociety.org/multimedia-library/brochures/newly-diag nosed/index.aspx (accessed July 21, 2009).
13. Jacobs L.D., Beck R.W., Simon J.H., et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med 343 (2000) 898-904
14. Kappos L., Polman C.H., Freedman M.S., et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 67 (2006) 1242-1249
15. Comi G., Filippi M., and Wolinsky J.S. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 49 (2001) 290-297
16. Bornstein M.B., Miller A., Slagle S., et al. A pilot study of COP 1 in exacerbating-remitting multiple sclerosis. N Engl J Med 317 (1987) 408-414
17. Johnson K.P., Brooks B.R., Cohen J.A., et al. Extended use of glatiramer acetate (GA) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology 50 (1998) 701-708
18. Poser C.M., Paty D.W., Scheinberg L., et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocol. Ann Neurol 13 (1983) 227-231
19. Miller D.H., Barkhof F., Berry I., Kappos L., Scotti G., and Thompson A.J. Magnetic resonance imaging in monitoring the treatment of multiple sclerosis: concerted action guide-lines. J Neurol Neurosurg Psychiatry 54 (1991) 683-688
20. Barkhof F., Filippi M., van Waesberghe J.H., et al. Improving inter-observer variation in reporting gadolinium-enhanced MRI lesions in multiple sclerosis. Neurology 49 (1997) 1682-1688
21. Filippi M., Gawne-Cain M.L., Gasperini C., et al. Effect of training and different measurement strategies on the reproducibility of brain MRI lesion lead measurements in multiple sclerosis. Neurology 50 (1998) 238-244
22. Sormani M.P., Rovaris M., Valsasina P., Wolinsky J.S., Comi G., and Filippi M. Measurement error of two different techniques for brain atrophy assessment in multiple sclerosis. Neurology 62 (2004) 1432-1434
23. Tintore M. Rationale for early intervention with immunomodulatory treatments. J Neurol 255 (2008) 37-43
24. Comi G., Filippi M., Barkhof F., et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357 (2001) 1576-1582
25. Mikol D.D., Barkhof F., Chang P., et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 7 (2008) 903-914
26. Comi G. Clinically isolated syndrome: the rationale for early treatment. Nat Clin Pract Neurol 4 (2008) 234-235
27. Beck R.W., Chandler D.L., Cole S.R., et al. Interferon beta-1a for early multiple sclerosis: CHAMPS trial subgroup analyses. Ann Neurol 51 (2002) 481-490