A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis
Background This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evalu... 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/s13075-017-1371-4 |
Permalink: | https://search.fid-benelux.de/Record/olc-benelux-1999703766 |
URL: | NULL NULL |
Datenquelle: | Online Contents Benelux; Originalkatalog |
Powered By: | Verbundzentrale des GBV (VZG) |
Link(s) : | http://dx.doi.org/10.1186/s13075-017-1371-4
http://dx.doi.org/10.1186/s13075-017-1371-4 |