Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

NCT00791921 ↗

Phase 3 Completed 230 enrolled Otsuka Pharmaceutical Co., Ltd. UCB Japan Co. Ltd. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Timeline

Start: 2008-11
Primary completion: 2010-01
Completion: 2010-01

Outcome

Met primary endpoint

paper significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) PMID 24981319 ↗

registry analysis (superiority or other test); CDP870 200mg vs Placebo; p <0.05; Regression, Logistic NCT00791921 ↗

Publications

Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Iwai K, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial. Mod Rheumatol. 2014 Jul;24(4):552-60. doi: 10.3109/14397595.2013.843764. Epub 2013 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab Pegol	Protein / enzyme biologic	200 mg	Subcutaneous