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

Astellas Pharma Inc86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Active Rheumatoid Arthritis

Interventions

CDP870DRUG

Self-injection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (15)

Unnamed facility

Aichi, Japan

Unnamed facility

Fukuoka, Japan

Unnamed facility

Gunma, Japan

Unnamed facility

Hiroshima, Japan

Outcomes

Primary Outcomes

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.

Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12

Time frame: at Week 12

Percentage of subjects who meet ACR20 criteria at Week 24

Time frame: at Week 24

Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12

Time frame: at Week 12

Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24

Time frame: at Week 24

Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12

Time frame: at Week 12

Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24

Time frame: at Week 24

Data from ClinicalTrials.gov

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