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

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00850343
First received: February 23, 2009
Last updated: June 26, 2013
Last verified: June 2013

February 23, 2009
June 26, 2013
March 2009
May 2013   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: At any time ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00850343 on ClinicalTrials.gov Archive Site
  • 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 ]
  • ACR20/50/70 responder rate [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • DAS28(ESR) [ Time Frame: Week 24, 52 ] [ Designated as safety issue: Yes ]
  • Modified Total Sharp Score [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-term Treatment Study of CDP870 Without Coadministration of MTX in Japanese Rheumatoid Arthritis (RA) Patients
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)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: CDP870 200 mg
    Subcutaneous (SC)
  • Drug: CDP870 400 mg
    SC
  • Experimental: CDP870 200 mg
    given every 2 weeks
    Intervention: Drug: CDP870 200 mg
  • Experimental: CDP870 400 mg
    given every 4 weeks
    Intervention: Drug: CDP870 400 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00850343
CDP870-275-08-004, JapicCTI-090701
No
Astellas Pharma Inc
Astellas Pharma Inc
UCB Japan Co. Ltd.
Not Provided
Astellas Pharma Inc
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP