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Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00791999
First received: November 14, 2008
Last updated: August 9, 2012
Last verified: August 2012
Results First Received: June 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CDP870 400mg
Drug: CDP870 200mg
Drug: CDP870 100mg
Drug: Placebo of CDP870

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in Japan between 2008 and 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow results are based on the safety set.

Reporting Groups
  Description
CDP870 100mg 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
CDP870 400mg 400mg CDP870 given every 2 weeks
Placebo Placebo given every 2 weeks

Participant Flow:   Overall Study
    CDP870 100mg     CDP870 200mg     CDP870 400mg     Placebo  
STARTED     72     82     85     77  
COMPLETED     51     66     65     25  
NOT COMPLETED     21     16     20     52  
Protocol planed withdrawal                 14                 11                 11                 45  
Withdrawal by Subject                 0                 1                 0                 2  
Protocol Violation                 3                 0                 1                 0  
Adverse Event                 3                 3                 7                 3  
Lack of Efficacy                 0                 1                 0                 2  
Reason other than those above                 1                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CDP870 100mg 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
CDP870 400mg 400mg CDP870 given every 2 weeks
Placebo Placebo given every 2 weeks
Total Total of all reporting groups

Baseline Measures
    CDP870 100mg     CDP870 200mg     CDP870 400mg     Placebo     Total  
Number of Participants  
[units: participants]
  72     82     85     77     316  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     61     77     66     68     272  
>=65 years     11     5     19     9     44  
Age  
[units: years]
Mean ± Standard Deviation
  54.3  ± 10.6     50.6  ± 11.4     55.4  ± 10.3     51.9  ± 11.1     53.0  ± 11.0  
Gender  
[units: participants]
         
Female     58     69     69     66     262  
Male     14     13     16     11     54  
Region of Enrollment  
[units: participants]
         
Japan     72     82     85     77     316  



  Outcome Measures
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1.  Primary:   American College of Rheumatology 20% (ACR20) Response at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 24   [ Time Frame: Baseline, Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kazuhiko Yamamoto, Medical Advisor of the Clinical Trial
Organization: Medical Advisor of the Clinical Trial
phone: +81 3 5800 8825
e-mail: yamamoto-tky@umin.ac.jp


No publications provided by Otsuka Pharmaceutical Co., Ltd.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00791999     History of Changes
Other Study ID Numbers: CDP870-275-08-001, JapicCTI-080665
Study First Received: November 14, 2008
Results First Received: June 18, 2012
Last Updated: August 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare