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)

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.

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

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