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
Primary Purpose
Active Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CDP870
Sponsored by
About this trial
This is an interventional treatment trial for Active Rheumatoid Arthritis focused on measuring CDP870, Rheumatoid arthritis, Long-term
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CDP870 group from Study 275-08-002
CDP870 group from Study 275-08-004
Arm Description
Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870
Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870
Outcomes
Primary Outcome Measures
Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study
Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12
Percentage of subjects who meet ACR20 criteria at Week 24
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24
Secondary Outcome Measures
Full Information
NCT ID
NCT02586246
First Posted
October 23, 2015
Last Updated
November 13, 2015
Sponsor
Astellas Pharma Inc
Collaborators
UCB Japan Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02586246
Brief Title
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
Official Title
Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer 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 Administered Concomitantly With or Without Methotrexate (MTX)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
UCB Japan Co. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis
Keywords
CDP870, Rheumatoid arthritis, Long-term
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDP870 group from Study 275-08-002
Arm Type
Experimental
Arm Description
Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870
Arm Title
CDP870 group from Study 275-08-004
Arm Type
Experimental
Arm Description
Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870
Intervention Type
Drug
Intervention Name(s)
CDP870
Intervention Description
Self-injection
Primary Outcome Measure Information:
Title
Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study
Time Frame
The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.
Title
Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12
Time Frame
at Week 12
Title
Percentage of subjects who meet ACR20 criteria at Week 24
Time Frame
at Week 24
Title
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12
Time Frame
at Week 12
Title
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24
Time Frame
at Week 24
Title
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12
Time Frame
at Week 12
Title
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24
Time Frame
at Week 24
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Aichi
Country
Japan
City
Fukuoka
Country
Japan
City
Gunma
Country
Japan
City
Hiroshima
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Kagawa
Country
Japan
City
Kagoshima
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Nagasaki
Country
Japan
City
Oita
Country
Japan
City
Saitama
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=1226-CL-A003
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
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
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