Long-term Treatment Study of CDP870 Without Coadministration of MTX in Japanese Rheumatoid Arthritis (RA) Patients

This study has been completed.
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: February 23, 2009
Last updated: June 26, 2013
Last verified: June 2013

The objectives of this study is to evaluate the safety and efficacy of CDP870 when administered without coadministration of MTX over the long term in Japanese RA patients who are transferred from the study (Study 275-08-003), as well as to evaluate the effects of dosing regimens on safety and efficacy of CDP870 in the ACR20 responders who completed Study 275-08-003.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: CDP870 200 mg
Drug: CDP870 400 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Adverse events [ Time Frame: At any time ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • American College of Rheumatology (ACR) 20/50/70 responder rate [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • Disease Activity Score (DAS) 28 (ESR) [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • Modified Total Sharp Score [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 208
Study Start Date: March 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP870 200 mg
given every 2 weeks
Drug: CDP870 200 mg
Subcutaneous (SC)
Experimental: CDP870 400 mg
given every 4 weeks
Drug: CDP870 400 mg

Detailed Description:

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.


Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who participated in Study 275-08-003 and meet all of the criteria described below.

    • Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

Exclusion Criteria:

  • Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
  • Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
  • Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
  • Patients who required treatment for the same infection at two or more different times during Study 275-08-003
  • Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
  • Patients whom the investigator has decided to be inappropriate for participation in the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00850343

Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
UCB Japan Co. Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00850343     History of Changes
Other Study ID Numbers: CDP870-275-08-004, JapicCTI-090701
Study First Received: February 23, 2009
Last Updated: June 26, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Certolizumab Pegol

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014