drugset / Trial / NCT00850343

Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

NCT00850343

Phase 3 Completed 208 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 when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), 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 275-08-003.

Timeline

Start
2009-03
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous
Subject Certolizumab Pegol Protein / enzyme biologic 400 mg Subcutaneous

Indications