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Trial record 4 of 31 for:    ACITRETIN

Acitretin and Etanercept in Psoriasis

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ClinicalTrials.gov Identifier: NCT00156247
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborator:
Connetics Corp.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: acitretin
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description patients on etanercept taking open-label acitretin
Period Title: Overall Study
Started 9
Completed 5
Not Completed 4
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description patients on etanercept taking open-label acitretin
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  88.9%
>=65 years
1
  11.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
45  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
2
  22.2%
Male
7
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
Hide Description Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description:
patients on etanercept taking open-label acitretin
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percent
12.5
2.Secondary Outcome
Title Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy
Hide Description Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description:
patients on etanercept taking open-label acitretin
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percent
50
3.Secondary Outcome
Title Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy
Hide Description Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description:
patients on etanercept taking open-label acitretin
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percent
37.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept With Acitretin
Hide Arm/Group Description patients on etanercept taking open-label acitretin
All-Cause Mortality
Etanercept With Acitretin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept With Acitretin
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etanercept With Acitretin
Affected / at Risk (%) # Events
Total   2/9 (22.22%)    
Skin and subcutaneous tissue disorders   
retinoid dermatitis  2/9 (22.22%)  2
dry/chapped lips  2/9 (22.22%)  2
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
Layout table for Results Point of Contact information
Name/Title: Melissa Magliocco, MD
Organization: UMDNJ-Robert Wood Johnson Medical School
Phone: (732) 235-5735
EMail: maglioma@umdnj.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00156247     History of Changes
Other Study ID Numbers: 5487
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: July 11, 2011
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015