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The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment

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ClinicalTrials.gov Identifier: NCT01511315
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Ustekinumab
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ustekinumab
Hide Arm/Group Description Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Period Title: Overall Study
Started 36
Completed 32
Not Completed 4
Arm/Group Title Ustekinumab
Hide Arm/Group Description Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
Patients who did not complete the study (n=4) were not included in the baseline analysis.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
41.2
(19 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
20
  62.5%
Male
12
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  21.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.3%
White
15
  46.9%
More than one race
0
   0.0%
Unknown or Not Reported
8
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.
Hide Description The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Time Frame Baseline, 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
23.97  (3.65)
2.Secondary Outcome
Title Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline
Hide Description The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Time Frame Baseline, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
week 24 19.97  (3.93)
week 12 18.63  (3.22)
3.Secondary Outcome
Title Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline
Hide Description The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)
Time Frame Baseline, 36 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Employment 1  (3.1)
total work productivity impairment -21.6  (36.4)
Absenteeism -4.8  (11.7)
Presenteeism 18.6  (35.2)
total activity impairment -26.6  (35.9)
4.Secondary Outcome
Title Change in Psoriasis Quality of Life – 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline
Hide Description The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient’s own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.
Time Frame Baseline, 12, 24, and 36 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
week 36 -38.34  (7.67)
week 24 -43.78  (8.01)
week 12 -40.06  (6.82)
5.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline
Hide Description The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.
Time Frame Baseline, 12, 24, and 36 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
week 36 12.91  (1.30)
week 24 13.65  (1.23)
week 12 13.00  (1.23)
6.Secondary Outcome
Title Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36
Hide Description The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.
Time Frame Weeks 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
week 36 71.8
week 24 67.7
week 12 56.3
7.Secondary Outcome
Title Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36
Hide Description The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.
Time Frame Weeks 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study were included in this analysis (n=32).
Arm/Group Title Ustekinumab
Hide Arm/Group Description:
Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
week 36 78.1
week 24 78.1
week 12 71.9
Time Frame 36 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ustekinumab
Hide Arm/Group Description Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
All-Cause Mortality
Ustekinumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ustekinumab
Affected / at Risk (%)
Total   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ustekinumab
Affected / at Risk (%)
Total   0/36 (0.00%) 
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: Mio Nakamura, MD
Organization: UCSF Psoriasis Center
Phone: 4154764701
EMail: mio.nakamura@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01511315     History of Changes
Other Study ID Numbers: Stelara QoL
First Submitted: January 12, 2012
First Posted: January 18, 2012
Results First Submitted: December 7, 2015
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016