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A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

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ClinicalTrials.gov Identifier: NCT00336973
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : June 5, 2009
Last Update Posted : July 23, 2015
Sponsor:
Information provided by:
Genentech, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: efalizumab
Enrollment 73

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Efalizumab
Hide Arm/Group Description After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Period Title: Overall Study
Started 66
Completed 33
Not Completed 33
Arm/Group Title Efalizumab
Hide Arm/Group Description After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants
45.6  (12.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
24
  36.4%
Male
42
  63.6%
1.Primary Outcome
Title Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)
Hide Description The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Time Frame Day 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT)
Arm/Group Title Efalizumab
Hide Arm/Group Description:
After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage
34.8
2.Secondary Outcome
Title Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)
Hide Description The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Time Frame Day 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT)
Arm/Group Title Efalizumab
Hide Arm/Group Description:
After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage
31.8
3.Secondary Outcome
Title Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Hide Description The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Time Frame Day 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT)
Arm/Group Title Efalizumab
Hide Arm/Group Description:
After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage
9.1
4.Secondary Outcome
Title Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)
Hide Description The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe
Time Frame Day 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT)
Arm/Group Title Efalizumab
Hide Arm/Group Description:
After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage
21.2
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.
 
Results Point of Contact
Name/Title: Medical Communications Specialist
Organization: Genentech, Inc.
Phone: 800-821-8590
Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00336973     History of Changes
Other Study ID Numbers: ACD3780g
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: April 15, 2009
Results First Posted: June 5, 2009
Last Update Posted: July 23, 2015