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A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT01126619
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : October 11, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Condition Psoriasis
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anti-TNF
Hide Arm/Group Description Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Period Title: Overall Study
Started 103
Completed 86 [1]
Not Completed 17
Reason Not Completed
Not eligible for the study             2
Investigator decision             4
Serious adverse event             1
Withdrawal by Subject             9
Non-compliance             1
[1]
The completed population was used for all effectiveness analyses.
Arm/Group Title Anti-TNF
Hide Arm/Group Description Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
44.9  (13.9)
[1]
Measure Description: Data available for 102 participants.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants
Female 40
Male 62
[1]
Measure Description: Data available for 102 participants.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 103 participants
103
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 103 participants
78.5  (16.0)
[1]
Measure Description: Data available for 102 participants.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 103 participants
166.9  (13.5)
[1]
Measure Description: Data available for 101 participants.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 103 participants
29.3  (14.9)
[1]
Measure Description: Data available for 101 participants.
Psoriasis Area and Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 103 participants
20.8  (11.2)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Dermatology Life Quality Index (DLQI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 103 participants
15.1  (7.3)
[1]
Measure Description: DLQI is a questionnaire to evaluate dermatology patients for their quality of life for the following subsets of parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Questions related with these parameters are summed up and the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on patient’s life whereas 0-1 means that the disease has no effect at all.
Duration of Psoriasis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
15.7  (9.2)
[1]
Measure Description: Data available for 102 participants.
1.Primary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Hide Description The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.
Time Frame Baseline and Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 4 48.65  (36.27)
Week 8 75.70  (36.11)
Week 16 87.85  (36.91)
Week 24 90.29  (25.49)
2.Primary Outcome
Title Percentage of Participants With 75% Reduction in PASI Score
Hide Description The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Time Frame Baseline and Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 31.4
Week 8 51.2
Week 16 67.4
Week 24 70.9
3.Secondary Outcome
Title Dynamic Physician Global Assessment (PGA) of Change in Psoriasis
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.51  (2.24)
4.Secondary Outcome
Title Dynamic Patient Global Assessment (PGA) of Change in Psoriasis
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.51  (2.26)
5.Secondary Outcome
Title Static Physician Global Assessment (PGA) of Psoriasis
Hide Description

In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:

Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Baseline Week 24
Hide Arm/Group Description:
Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
Overall Number of Participants Analyzed 86 86
Measure Type: Number
Unit of Measure: participants
Clear psoriasis 0 14
Psoriasis almost clear 0 38
Mild psoriasis 0 19
Mild to moderate psoriasis 1 4
Moderate psoriasis 35 8
Moderate to severe psoriasis 27 3
Severe psoriasis 23 0
6.Secondary Outcome
Title Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Hide Description

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.

Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Time Frame Baseline and Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Mean (Full Range)
Unit of Measure: percent change
Week 4
53.13
(-133.33 to 100.00)
Week 8
66.40
(-80.00 to 100.00)
Week 16
73.98
(-58.33 to 100.00)
Week 24
65.72
(-166.67 to 100.00)
7.Secondary Outcome
Title Percent Change From Baseline in Work Productivity and Activity Impairment
Hide Description

The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):

  • Percent work time missed in the last 7 days due to problems associated with psoriasis;
  • Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
  • Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
  • Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.

Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 86
Mean (Full Range)
Unit of Measure: percent change
Work time missed
96
(0 to 100)
Impairment at work
72
(0 to 100)
Overall loss of work productivity
75
(0 to 100)
Activity impairment
72
(0 to 100)
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.

Please see the Adverse Event module below for additional details.

Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Anti-TNF
Hide Arm/Group Description:
Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
Any adverse event 28
Serious adverse event 3
Time Frame 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-TNF
Hide Arm/Group Description Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
All-Cause Mortality
Anti-TNF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anti-TNF
Affected / at Risk (%)
Total   3/103 (2.91%) 
Gastrointestinal disorders   
Hepatotoxicity, Toxic Hepatitis  1  1/103 (0.97%) 
Infections and infestations   
Catheter infection, infected endocarditis  1  1/103 (0.97%) 
Respiratory, thoracic and mediastinal disorders   
Gangrenous emphysema  1  1/103 (0.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anti-TNF
Affected / at Risk (%)
Total   7/103 (6.80%) 
General disorders   
Injection site reaction  1  7/103 (6.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.0
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01126619     History of Changes
Other Study ID Numbers: P12-130
First Submitted: May 18, 2010
First Posted: May 20, 2010
Results First Submitted: September 7, 2012
Results First Posted: October 11, 2012
Last Update Posted: October 25, 2012