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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• 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 275-08-001 and meet all of the criteria described below.

• Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week 24.

• Patients who are able to receive treatment with MTX, by Week 52.

Exclusion Criteria:

• Patients who experienced an important protocol deviation as mentioned below during Study 275-08-001.

• Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).

• Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.

• Patients who required treatment for the same infection at two or more different times during Study 275-08-001

• 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