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, Vol. 77, No. 16, 18.10.2011, p. 1551-60.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -