Full Text View
Tabular View
Study Results
Related Studies
Adalimumab in Adult Japanese Subjects With Psoriasis
This study has been completed.
Study NCT00647400   Information provided by Abbott

First Received on March 27, 2008.   Last Updated on April 1, 2011   History of Changes
Results First Received: December 4, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Biological: adalimumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Japanese participants with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adalimumab 40 mg Every Other Week Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
Adalimumab 80 mg Every Other Week Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).

Participant Flow:   Overall Study
    Adalimumab 40 mg Every Other Week     Adalimumab 80 mg Every Other Week  
STARTED     89     58  
COMPLETED     67     45  
NOT COMPLETED     22     13  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Adalimumab 40 mg Every Other Week Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
Adalimumab 80 mg Every Other Week Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).

Baseline Measures
    Adalimumab 40 mg Every Other Week     Adalimumab 80 mg Every Other Week     Total  
Number of Participants  
[units: participants]
  89     58     147  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     80     56     136  
>=65 years     9     2     11  
Age  
[units: years]
Mean ± Standard Deviation
  45.1  ± 13.39     42.9  ± 11.88     44.2  ± 12.82  
Gender  
[units: participants]
     
Female     13     10     23  
Male     76     48     124  
Region of Enrollment  
[units: participants]
     
Japan     89     58     147  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)   [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ]

2.  Secondary:   Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)   [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ]

3.  Secondary:   Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)   [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ]


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided


Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00647400     History of Changes
Other Study ID Numbers: M04-702
Study First Received: March 27, 2008
Results First Received: December 4, 2009
Last Updated: April 1, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare