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A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS

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A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS. / Freedman, M S; Bar-Or, A; Oger, J; Traboulsee, A; Patry, D; Young, C; Olsson, T; Li, D; Hartung, H-P; Krantz, M; Ferenczi, L; Verco, T; MAESTRO-01 Investigators; Stürner, Klarissa.

in: NEUROLOGY, Jahrgang 77, Nr. 16, 18.10.2011, S. 1551-60.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Freedman, MS, Bar-Or, A, Oger, J, Traboulsee, A, Patry, D, Young, C, Olsson, T, Li, D, Hartung, H-P, Krantz, M, Ferenczi, L, Verco, T, MAESTRO-01 Investigators & Stürner, K 2011, 'A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS', NEUROLOGY, Jg. 77, Nr. 16, S. 1551-60. https://doi.org/10.1212/WNL.0b013e318233b240

APA

Freedman, M. S., Bar-Or, A., Oger, J., Traboulsee, A., Patry, D., Young, C., Olsson, T., Li, D., Hartung, H-P., Krantz, M., Ferenczi, L., Verco, T., MAESTRO-01 Investigators, & Stürner, K. (2011). A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS. NEUROLOGY, 77(16), 1551-60. https://doi.org/10.1212/WNL.0b013e318233b240

Vancouver

Freedman MS, Bar-Or A, Oger J, Traboulsee A, Patry D, Young C et al. A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS. NEUROLOGY. 2011 Okt 18;77(16):1551-60. https://doi.org/10.1212/WNL.0b013e318233b240

Bibtex

@article{2c6c261082174840a38ef0a568f051ba,
title = "A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS",
abstract = "OBJECTIVE: To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)).METHODS: This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life.RESULTS: There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified.CONCLUSION: In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. Classification of evidence: This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).",
keywords = "Adult, Aged, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Longitudinal Studies, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Myelin Basic Protein, Peptide Fragments, Quality of Life, Severity of Illness Index, Time Factors, Treatment Outcome",
author = "Freedman, {M S} and A Bar-Or and J Oger and A Traboulsee and D Patry and C Young and T Olsson and D Li and H-P Hartung and M Krantz and L Ferenczi and T Verco and {MAESTRO-01 Investigators} and Klarissa St{\"u}rner",
year = "2011",
month = oct,
day = "18",
doi = "10.1212/WNL.0b013e318233b240",
language = "English",
volume = "77",
pages = "1551--60",
journal = "NEUROLOGY",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "16",

}

RIS

TY - JOUR

T1 - A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS

AU - Freedman, M S

AU - Bar-Or, A

AU - Oger, J

AU - Traboulsee, A

AU - Patry, D

AU - Young, C

AU - Olsson, T

AU - Li, D

AU - Hartung, H-P

AU - Krantz, M

AU - Ferenczi, L

AU - Verco, T

AU - MAESTRO-01 Investigators

AU - Stürner, Klarissa

PY - 2011/10/18

Y1 - 2011/10/18

N2 - OBJECTIVE: To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)).METHODS: This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life.RESULTS: There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified.CONCLUSION: In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. Classification of evidence: This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).

AB - OBJECTIVE: To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)).METHODS: This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life.RESULTS: There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified.CONCLUSION: In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. Classification of evidence: This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+).

KW - Adult

KW - Aged

KW - Disability Evaluation

KW - Disease Progression

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Longitudinal Studies

KW - Magnetic Resonance Imaging

KW - Male

KW - Middle Aged

KW - Multiple Sclerosis

KW - Myelin Basic Protein

KW - Peptide Fragments

KW - Quality of Life

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1212/WNL.0b013e318233b240

DO - 10.1212/WNL.0b013e318233b240

M3 - SCORING: Journal article

C2 - 21975206

VL - 77

SP - 1551

EP - 1560

JO - NEUROLOGY

JF - NEUROLOGY

SN - 0028-3878

IS - 16

ER -