drugset / Trial / NCT00851318

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

NCT00851318

Phase 3 Completed 285 enrolled Astellas Pharma Inc UCB Japan Co. Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-03
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous
Subject Certolizumab Pegol Protein / enzyme biologic 400 mg Subcutaneous
Background Methotrexate Small molecule 6 mg
Background Methotrexate Small molecule 8 mg

Indications