NCT00791999

Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CDP870 400mg	400mg CDP870 given every 2 weeks until Week22 (SC)
DRUG	CDP870 200mg	400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)
DRUG	CDP870 100mg	200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)
DRUG	Placebo of CDP870	given every 2 weeks until Week22 (SC)

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2008-11-17
• Last updated: 2012-08-10
• Results posted: 2012-08-06

Locations

8 sites across 1 country: Japan