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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: UCB Japan Co. Ltd.
• Treatments: Certolizumab Pegol; Methotrexate

Criteria

Inclusion Criteria:

• Subjects who participated in Study 275-08-003 and meet all of the criteria described below.

• Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

Exclusion Criteria:

• Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.

• Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).

• Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.

• Patients who required treatment for the same infection at two or more different times during Study 275-08-003

• Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.

• Patients whom the investigator has decided to be inappropriate for participation in the study