NCT00851318

Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-001.

Detailed description

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Certolizumab pegol	Subcutaneous (SC) injection
DRUG	Methotrexate	Methotrexate dose between 6 to 8 mg/week.

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-02-25
• Last updated: 2014-11-03
• Results posted: 2014-09-17

Locations

8 sites across 1 country: Japan