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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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00791999     History of Changes
Other Study ID Numbers: CDP870-275-08-001
JapicCTI-080665 ( Other Identifier: JAPIC )
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