PMID- 28607708
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2055-2173 (Print)
IS  - 2055-2173 (Electronic)
IS  - 2055-2173 (Linking)
VI  - 1
DP  - 2015 Jan-Dec
TI  - A randomized trial of teriflunomide added to glatiramer acetate in relapsing 
      multiple sclerosis.
PG  - 2055217315618687
LID - 10.1177/2055217315618687 [doi]
LID - 2055217315618687
AB  - BACKGROUND: Teriflunomide is a once-daily oral immunomodulator for the treatment 
      of relapsing-remitting MS. OBJECTIVE: To evaluate the safety and tolerability of 
      teriflunomide as add-on therapy to a stable dose of glatiramer acetate (GA) in 
      patients with relapsing forms of MS (RMS). METHODS: Phase II, randomized, 
      double-blind, add-on, placebo-controlled study. The primary objective was to 
      assess safety and tolerability; secondary objectives were to evaluate effects of 
      treatment on disease activity assessed by MRI and relapse. RESULTS: Patients with 
      RMS on GA (N = 123) were randomized 1:1:1 to receive teriflunomide 14 mg 
      (n = 40), 7 mg (n = 42), or placebo (n = 41) for 24 weeks; 96 patients entered 
      the 24-week extension, remaining on original treatment allocation. Teriflunomide 
      was well tolerated over 48 weeks. The frequency of adverse events (AEs) was low 
      across all groups; 5 (12.2%), 3 (7.1%), and 2 (5.0%) patients in the 14 mg, 7 mg, 
      and placebo groups, respectively, discontinued treatment due to AEs. 
      Teriflunomide reduced the number of T1-Gd lesions vs placebo (14 mg: 46.6% 
      relative reduction, p = 0.1931; 7 mg: 64.0%: relative reduction, p = 0.0306). 
      CONCLUSIONS: Teriflunomide added to stable-dose GA had acceptable safety and 
      tolerability, and reduced some MRI markers of disease activity compared with GA 
      alone. NCT00475865 (core study); NCT00811395 (extension).
FAU - Freedman, M S
AU  - Freedman MS
AD  - University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada.
FAU - Wolinsky, J S
AU  - Wolinsky JS
AD  - University of Texas Health Science Center at Houston, Houston, TX, USA.
FAU - Truffinet, P
AU  - Truffinet P
AD  - Genzyme, a Sanofi company, Chilly-Mazarin, France.
FAU - Comi, G
AU  - Comi G
AD  - University Vita-Salute San Raffaele, Milan, Italy.
FAU - Kappos, L
AU  - Kappos L
AD  - University Hospital Basel, Basel, Switzerland.
FAU - Miller, A E
AU  - Miller AE
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Olsson, T P
AU  - Olsson TP
AD  - Karolinska Institute, Stockholm, Sweden.
FAU - Benamor, M
AU  - Benamor M
FAU - Chambers, S
AU  - Chambers S
AD  - Fishawack Communications Ltd, Abingdon, UK.
FAU - O'Connor, P W
AU  - O'Connor PW
AD  - University of Toronto, Toronto, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT00475865
SI  - ClinicalTrials.gov/NCT00811395
PT  - Journal Article
DEP - 20151207
PL  - United States
TA  - Mult Scler J Exp Transl Clin
JT  - Multiple sclerosis journal - experimental, translational and clinical
JID - 101668877
PMC - PMC5433345
OTO - NOTNLM
OT  - MRI
OT  - Randomized clinical trial
OT  - multiple sclerosis
OT  - relapsing - remitting multiple sclerosis
OT  - safety
EDAT- 2015/12/07 00:00
MHDA- 2015/12/07 00:01
PMCR- 2015/12/07
CRDT- 2017/06/14 06:00
PHST- 2017/06/14 06:00 [entrez]
PHST- 2015/12/07 00:00 [pubmed]
PHST- 2015/12/07 00:01 [medline]
PHST- 2015/12/07 00:00 [pmc-release]
AID - 10.1177_2055217315618687 [pii]
AID - 10.1177/2055217315618687 [doi]
PST - epublish
SO  - Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 
      10.1177/2055217315618687. eCollection 2015 Jan-Dec.