A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study
Background CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®). The aim of this study was to compare the 54-week efficacy, immunogenicity, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of CT-P13 and RP in patients with active rheumatoid arthritis (RA). Methods In this multinational phase III double-blind study, patients with active RA and an inadequate response to methotrexate (MTX) were randomized (1:1) to receive CT-P13 (3 mg/kg) or RP (3 mg/kg) at weeks 0, 2, 6 and then every 8 weeks to week 54 in combination with MTX (12.5-25 mg/week)... Mehr ...
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Dokumenttyp: | Artikel |
Reihe/Periodikum: | Arthritis research & therapy |
Verlag/Hrsg.: |
London,
BioMed Central
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Sprache: | Englisch |
ISSN: | 1478-6354 |
Weitere Identifikatoren: | doi: 10.1186/s13075-016-0981-6 |
Permalink: | https://search.fid-benelux.de/Record/olc-benelux-1989798101 |
URL: | NULL NULL |
Datenquelle: | Online Contents Benelux; Originalkatalog |
Powered By: | Verbundzentrale des GBV (VZG) |
Link(s) : | http://dx.doi.org/10.1186/s13075-016-0981-6
http://dx.doi.org/10.1186/s13075-016-0981-6 |
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