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

Phase 3

Completed

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: 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

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16

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