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A randomized trial ...
A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis
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Freedman, MS (författare)
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Wolinsky, JS (författare)
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Truffinet, P (författare)
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Comi, G (författare)
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Kappos, L (författare)
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Miller, AE (författare)
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- Olsson, TP (författare)
- Karolinska Institutet
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Benamor, M (författare)
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Chambers, S (författare)
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O'Connor, PW (författare)
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(creator_code:org_t)
- 2015-12-07
- 2015
- Engelska.
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Ingår i: Multiple sclerosis journal - experimental, translational and clinical. - : SAGE Publications. - 2055-2173. ; 1, s. 2055217315618687-
- Relaterad länk:
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https://journals.sag...
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http://kipublication...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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).
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Freedman, MS
-
Wolinsky, JS
-
Truffinet, P
-
Comi, G
-
Kappos, L
-
Miller, AE
-
visa fler...
-
Olsson, TP
-
Benamor, M
-
Chambers, S
-
O'Connor, PW
-
visa färre...
- Artiklar i publikationen
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Multiple scleros ...
- Av lärosätet
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Karolinska Institutet