Clinical trial NCT02586246: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Rheumatoid Arthritis
Keywords: CDP870
Rheumatoid arthritis
Long-term
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: UCB Japan Co. Ltd.
First posted: 2015-10-26
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study
timeFrame: The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.
measure: Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12
timeFrame: at Week 12
measure: Percentage of subjects who meet ACR20 criteria at Week 24
timeFrame: at Week 24
measure: Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12
timeFrame: at Week 12
measure: Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24
timeFrame: at Week 24
measure: Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12
timeFrame: at Week 12
measure: Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24
timeFrame: at Week 24
Secondary outcomes:
Other outcomes:
Locations:
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
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: