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
- Registration Number
- NCT02586246
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDP870 group from Study 275-08-002 CDP870 Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870 CDP870 group from Study 275-08-004 CDP870 Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870
- Primary Outcome Measures
Name Time Method Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks. Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12 at Week 12 Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24 at Week 24 Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24 at Week 24 Percentage of subjects who meet ACR20 criteria at Week 24 at Week 24 Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12 at Week 12 Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12 at Week 12
- Secondary Outcome Measures
Name Time Method