Status:
COMPLETED
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
UCB Japan Co. Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief 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...
Detailed Description
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00851318
Start Date
March 1 2009
End Date
June 1 2013
Last Update
November 3 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan