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URL: https://dx.doi.org/DOI:10.17504/protocols.io.3r2gm8e

Authors: Takahiro Ito, Masayuki Takanuma, Yasumasa Arai

Summary: FKB327 is a biosimilar of the adalimumab reference product (RP). The formulation excipients of the FKB327 differ from those of the citrate-containing formulation of the RP, thus injection-site pain (ISP) at subcutaneous injection were assessed in single-dose studies (FKB327-001 and -004) in healthy subjects and multiple-dose studies (FKB327-002 (NCT02260791) and -003 (NCT02405780) in patients with rheumatoid arthritis. Outline of individual study design can be refered to in appendicies 1 to 4 for FKB327-001, -002, -003, and -004 studies, respectively.In all 4 studies, ISP was assessed using visual analog scale (VAS) with a horizontal scale from 0 to 100 mm (0 to 100 scale in KB327-002 and -003 using ePRO device) with the left end point signifying “no pain” and the right end point signifying “intolerable pain”. In order to evaluate potencial difference in ISP among products, devices of FKB327, or the other subjects’ background factors, this systemic anapysis using pooled data from these studies was planned.

Affiliations: Fujifilm Kyowa Kirin Biologics, Fujifilm Kyowa Kirin Biologics, Fujifilm Kyowa Kirin Biologics

External URL: https://clinicaltrials.gov/ct2/show/NCT02260791, https://clinicaltrials.gov/ct2/show/NCT02405780

Version: 1

Publication Date: 2019

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