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

November 13, 2015 updated by: Astellas Pharma Inc

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
      • Fukuoka, Japan
      • Gunma, Japan
      • Hiroshima, Japan
      • Hokkaido, Japan
      • Hyogo, Japan
      • Kagawa, Japan
      • Kagoshima, Japan
      • Kanagawa, Japan
      • Kumamoto, Japan
      • Nagasaki, Japan
      • Oita, Japan
      • Saitama, Japan
      • Tokushima, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

UCB Japan Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1226-CL-A003
  • 275-10-001 (Other Identifier: UCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Active Rheumatoid Arthritis

Clinical Trials on CDP870

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe