Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791921
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : August 6, 2012
Last Update Posted : August 7, 2012
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CDP870
Drug: Placebo of CDP870

  Participant Flow

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
CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
Placebo Placebo of CDP870

Participant Flow:   Overall Study
    CDP870 200mg   Placebo
STARTED   116   114 
COMPLETED   82   18 
NOT COMPLETED   34   96 
Protocol planed                24                88 
Withdrawal by Subject                1                2 
Adverse Event                8                2 
Lack of Efficacy                0                2 
Lack of study drug administration                1                1 
Reason other than those above                0                1 

  Baseline Characteristics

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

Baseline Measures
   CDP870 200mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   114   230 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   88   94   182 
>=65 years   28   20   48 
[Units: Years]
Mean (Standard Deviation)
 56.0  (10.2)   55.4  (9.8)   55.7  (10.0) 
[Units: Participants]
Female   83   88   171 
Male   33   26   59 
Region of Enrollment 
[Units: Participants]
Japan   116   114   230 

  Outcome Measures

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

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

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: Professor, Department of Allergy and Rheumatology, Division of Internal Medicine, Graduate School of Medicine, University of Tokyo
phone: +81 3 5800 8825

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

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT00791921     History of Changes
Other Study ID Numbers: CDP870-275-08-003
First Submitted: November 14, 2008
First Posted: November 17, 2008
Results First Submitted: June 18, 2012
Results First Posted: August 6, 2012
Last Update Posted: August 7, 2012