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news.Abbott Japan and Eisai have filed an application in Japan for the approval for the additional indication of Humira (adalimumab; recombinant) Pre-filled Syringe 40mg/0.8ml, to treat structural damage of joints in rheumatoid arthritis.
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The filing of the application is backed by the results of a double-blind study (Hopeful1 Study) which included around 334 rheumatoid arthritis patients and received concomitant treatment using either Humira with MTX or placebo with MTX.
The results of the trial demonstrated that with Humira with MTX improved clinical symptoms and physical function.
In the trial, Humira was well-tolerated in combination with MTX.