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)

Astellas Pharma Inc.0 sites222 target enrollmentFebruary 18, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 18, 2009

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Subjecs 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\.

•\- 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 .