NCT00993317

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo of 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 Week 22(SC)
DRUG	Methotrexate	Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit. The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-10-12
• Last updated: 2012-09-27
• Results posted: 2012-09-27

Locations

15 sites across 1 country: South Korea