ong-term Treatment Study of CDP870 without coadministration of MTX in Japanese RA patients
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080220676
- Lead Sponsor
- Astellas Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 130
Subjecs who participated in Study 275-08-003 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003
- Patients who received live or attenuated vaccines during Study 275-08-003(Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-003
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverce events<br>At any time
- Secondary Outcome Measures
Name Time Method ACR20/50/70 responder rate<br><br>Week24, 52<br><br>DAS28(ESR)<br><br>Week24, 52<br><br>Modified Total Sharp Score<br><br>Week24