Overview

Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborator:
UCB Japan Co. Ltd.
Treatments:
Certolizumab Pegol
Criteria
Inclusion Criteria:

- Subjects who have completed the treatment in the parent clinical studies (NCT00851318
and NCT00850343) up to 52 weeks

- Subjects who are willing to undertake self-injection and provide a written consent

Exclusion Criteria:

- Patients with serious adverse events

- Patients who are judged by the investigator/subinvestigator to be ineligible to
participation in the study for reasons such as uncooperative attitude or nonadherence
to study procedures.