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Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195676
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
Results First Received: October 20, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Drug: adalimumab

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
All Adalimumab Treatment All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.

Baseline Measures
    All Adalimumab Treatment  
Number of Participants  
[units: participants]
 		  1468  
Age  
[units: years]
Mean ± Standard Deviation 		  44.1  ± 12.75  
Gender  
[units: participants]
 		 
Female     470  
Male     998  
Region of Enrollment  
[units: participants]
 		 
United States     802  
Canada     501  
Austria     34  
Belgium     15  
France     45  
Switzerland     3  
Spain     20  
Poland     12  
Germany     36  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R   [ Time Frame: Week 16 of Period R ]
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2.  Other Pre-specified:   Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60   [ Time Frame: Week 60 ]
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3.  Other Pre-specified:   Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120   [ Time Frame: Week 120 ]
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4.  Other Pre-specified:   Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60   [ Time Frame: Week 60 ]
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5.  Other Pre-specified:   Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120   [ Time Frame: Week 120 ]
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6.  Other Pre-specified:   Time to Relapse in Period W   [ Time Frame: Period W ]
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7.  Other Pre-specified:   Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R   [ Time Frame: Week 16 of Period R ]
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8.  Other Pre-specified:   Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R   [ Time Frame: Week 16 of Period R ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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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 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 by Abbott

Publications automatically indexed to this study:


Responsible Party: Martin M. Okun, MD, PhD/Medical Director, Immunology, Abbott
ClinicalTrials.gov Identifier: NCT00195676     History of Changes
Other Study ID Numbers: M03-658, 2005-000095-41
Study First Received: September 13, 2005
Results First Received: October 20, 2010
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration