This study was prematurely terminated due to low enrollment and not for safety reasons.
Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
Sponsor study identifier
observational
30
1 country
3
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2010
Actual (reported)July 5, 2010
Actual (reported)November 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)August 2013
Actual (reported)August 25, 2014
Actual (reported)Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
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.
Baseline to Week 16
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
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.
Baseline to Week 16
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
Baseline, Week 16
Number of Participants With Serious Adverse Events (SAEs)
From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
Adherence to Adalimumab Treatment
up to 16 weeks
Mean Psoriasis Area and Severity Index (PASI) Score Over Time
Baseline, Week 4, Week 8, Week 16
Mean Dermatology Life Quality Index (DLQI) Score Over Time
Baseline, Week 4, Week 8, Week 16
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.
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
Site Reference ID/Investigator# 35783
Lima, Peru
Site Reference ID/Investigator# 56700
Lima, Peru
Site Reference ID/Investigator# 43147
Trujillo, Peru
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.
Manuel Uribe, MD
AbbVie
30 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2010
First Posted
July 5, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
August 25, 2014
Results First Posted
August 25, 2014
Record last verified: 2014-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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