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

Active Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586246
• Other study ID #: 1226-CL-A003
• Secondary ID: 275-10-001
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2015
• Last updated: November 13, 2015
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• CDP870
Self-injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12		at Week 12	No
Primary	Percentage of subjects who meet ACR20 criteria at Week 24		at Week 24	No
Primary	Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12		at Week 12	No
Primary	Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24		at Week 24	No
Primary	Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12		at Week 12	No
Primary	Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24		at Week 24	No

External Links

•   Link to results on Astellas Clinical Study Results Web site