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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Active Rheumatoid Arthritis

Intervention / Treatment
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* Drug: CDP870


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP870 group from Study 275-08-002<br>Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870 | Drug: CDP870<br>* Self-injection<br>|
| Experimental: CDP870 group from Study 275-08-004<br>Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870 | Drug: CDP870<br>* Self-injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ACR20 criteria at Week 24 |  | at Week 24 | 
| Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12 |  | at Week 12 | 
| Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) 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 70% (ACR70) criteria at Week 24 |  | at Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDP870, Rheumatoid arthritis, Long-term