Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis-Reference-Cited by-同舟云学术

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

Published:2015-04-02 Issue:6 Volume:25 Page:817-824
ISSN:1439-7595
Container-title:Modern Rheumatology
language:en
Short-container-title:Modern Rheumatology

Author:

Takeuchi Tsutomu¹,Yamanaka Hisashi²,Tanaka Yoshiya³,Sakurai Takeo⁴,Saito Kazuyoshi³,Ohtsubo Hideo⁵,Lee Sang Joon⁶,Nambu Yoshihiro⁷

Affiliation:

1. Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan

2. Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan

3. First Department of Internal Medicine, University of Occupational and Environmental Health, Fukuoka, Japan

4. Inoue Hospital, Gunma, Japan

5. Kagoshima Red Cross Hospital, Kagoshima, Japan

6. Data center, Product development, Celltrion, Inc., Incheon, Republic of Korea

7. Pharmaceutical Development Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd., Tokyo, Japan

Publisher

Oxford University Press (OUP)

Subject

Rheumatology

Link

https://www.tandfonline.com/doi/pdf/10.3109/14397595.2015.1022297

Reference17 articles.

1. World Health Organization. Expert committee on biological standardization. Geneva, 2009 October 19–23. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.

2. Physicochemical characterization of Remsima®

3. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

4. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

5. The american rheumatism association 1987 revised criteria for the classification of rheumatoid arthritis

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