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

2001 ◽  
Vol 49 (3) ◽  
pp. 290-297 ◽  
Author(s):  
Giancarlo Comi ◽  
Massimo Filippi ◽  
Jerry S. Wolinsky ◽  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Multiple Sclerosis ◽  
Magnetic Resonance ◽  
Disease Activity ◽  
Glatiramer Acetate ◽  
Controlled Study ◽  
Resonance Imaging ◽  
Double Blind ◽  
Relapsing Multiple Sclerosis

scholarly journals Patterns of disease activity in multiple sclerosis: clinical and magnetic resonance imaging study.

BMJ ◽  
1990 ◽  
Vol 300 (6725) ◽  
pp. 631-634 ◽  
Author(s):  
A J Thompson ◽  
A G Kermode ◽  
D G MacManus ◽  
B E Kendall ◽  
D P Kingsley ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Multiple Sclerosis ◽  
Magnetic Resonance ◽  
Disease Activity ◽  
Imaging Study ◽  
Magnetic Resonance Imaging Study ◽  
Resonance Imaging

scholarly journals Rituximab vs placebo induction prior to glatiramer acetate monotherapy in multiple sclerosis

Neurology ◽  
2019 ◽  
Vol 92 (7) ◽  
pp. e723-e732 ◽  
Author(s):  
Justin M. Honce ◽  
Kavita V. Nair ◽  
Stefan Sillau ◽  
Brooke Valdez ◽  
Augusto Miravalle ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Controlled Study ◽  
Short Term ◽  
Double Blind ◽  
T2 Lesions ◽  
Time To Treatment Failure ◽  
Sustained Change ◽  
Baseline Characteristics ◽  
Relapsing Multiple Sclerosis

ObjectiveTo examine whether rituximab induction followed by glatiramer acetate (GA) monotherapy is more effective than GA alone for the treatment of relapsing multiple sclerosis with active disease.MethodsThis was a single-center, double-blind, placebo-controlled study. Fifty-five participants were randomly assigned (1:1 ratio) to either rituximab (R-GA) or placebo (P-GA) induction, followed by GA therapy initiated in all participants. Participants were followed up to 3 years. The primary endpoint was the number of participants with no evidence of disease activity (NEDA): those without relapse, new MRI lesions, and sustained change in disability.ResultsTwenty-eight and 27 participants received rituximab and placebo induction, respectively, with one participant in each arm withdrawing before 6-month MRI. There were no significant differences in baseline characteristics. At end of study, 44.44% of R-GA participants demonstrated NEDA vs 19.23% of P-GA participants (p = 0.049). Treatment failed for a smaller proportion of R-GA participants (37.04% R-GA vs 69.23% P-GA, p = 0.019), and time to treatment failure was longer (23.32 months R-GA vs 11.29 months P-GA, p = 0.027). Fewer participants in the R-GA arm had new lesions (25.93% R-GA vs 61.54% P-GA, p = 0.009), and there were fewer new T2 lesions (0.48 R-GA vs 1.96 P-GA, p = 0.027). Probability of demonstrating NEDA in the R-GA arm returned to baseline within the study period. There were no differences in adverse events.ConclusionsInduction therapy with rituximab followed by GA may provide superior efficacy in the short term than GA alone in relapsing multiple sclerosis, but this benefit appears to wane within the study period. Larger studies are needed to assess sustainability of results.ClinicalTrials.gov identifierNCT01569451.

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