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Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

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ClinicalTrials.gov Identifier: NCT01156532
Recruitment Status : Terminated (This study was prematurely terminated due to low enrollment and not for safety reasons.)
First Posted : July 5, 2010
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Moderate to Severe Psoriasis
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Family Reasons             1
Lost to Follow-up             1
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
51  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
3
  10.0%
Male
27
  90.0%
1.Primary Outcome
Title Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78
(61 to 95)
2.Primary Outcome
Title Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92
(83 to 100)
3.Secondary Outcome
Title European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
Hide Description EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.48  (0.40)
Week 16 0.80  (0.32)
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.
Time Frame From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study treatment.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
1
5.Secondary Outcome
Title Adherence to Adalimumab Treatment
Hide Description Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
Time Frame up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study treatment.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
No Missed Doses 24
One Missed Dose 3
Two Missed Doses 2
6.Secondary Outcome
Title Mean Psoriasis Area and Severity Index (PASI) Score Over Time
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.
Time Frame Baseline, Week 4, Week 8, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.8  (9.0)
Week 4 10.6  (9.8)
Week 8 6.7  (8.4)
Week 16 4.2  (9.1)
7.Secondary Outcome
Title Mean Dermatology Life Quality Index (DLQI) Score Over Time
Hide Description DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.
Time Frame Baseline, Week 4, Week 8, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.3  (5.5)
Week 4 10.8  (6.0)
Week 8 5.9  (5.5)
Week 16 4.6  (7.9)
Time Frame From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
Adverse Event Reporting Description Adverse events are reported for all participants who received at least one dose of study treatment.
 
Arm/Group Title Adalimumab Treatment in Participants With Psoriasis
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
All-Cause Mortality
Adalimumab Treatment in Participants With Psoriasis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab Treatment in Participants With Psoriasis
Affected / at Risk (%)
Total   1/29 (3.45%) 
Infections and infestations   
Cellulitis * 1  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab Treatment in Participants With Psoriasis
Affected / at Risk (%)
Total   0/29 (0.00%) 
Although a sample of 75 participants was originally planned, only 30 participants were enrolled in this study. The limited sample size can result in a potential sampling bias that cannot be tested.
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.
AbbVie 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. AbbVie 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 AbbVie 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: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01156532     History of Changes
Other Study ID Numbers: P12-261
First Submitted: July 1, 2010
First Posted: July 5, 2010
Results First Submitted: August 8, 2014
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014