NCT00791921

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

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CDP870	400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
DRUG	Placebo of CDP870	Placebo given every 2 weeks until Week22 (SC)

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-11-17
• Last updated: 2012-08-07
• Results posted: 2012-08-06

Locations

7 sites across 1 country: Japan