Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Active Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CDP870

Drug

Self-injection

Primary outcomes

  1. 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.

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

    Time frame: at Week 12

  3. Percentage of subjects who meet ACR20 criteria at Week 24

    Time frame: at Week 24

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

    Time frame: at Week 12

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

    Time frame: at Week 24

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

    Time frame: at Week 12

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

    Time frame: at Week 24

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • UCB Japan Co. Ltd.

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2015
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.