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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
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis focused on measuring CDP870, Rheumatoid arthritis, Long-term

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 23, 2015
Last Updated
November 13, 2015
Sponsor
Astellas Pharma Inc
Collaborators
UCB Japan Co. Ltd.
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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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