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

Terminated

Conditions: Moderate to Severe Psoriasis

Registration Number: NCT01156532

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 30

Inclusion Criteria

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
Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol

Exclusion Criteria

Participants should not be enrolled if they cannot be treated in accordance with the local product label
Participants enrolled into another study or clinical trial
History of hepatitis B infection
History of neurologic symptoms suggestive of central nervous system demyelinating disease
History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
Use of another anti-tumoral necrosis factor previously
History of congestive heart failure
Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
Participants with active infection including chronic or localized infections until infections are controlled
History of sensitivity to latex
Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response	Baseline to Week 16	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.
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score	Baseline to Week 16	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.

Secondary Outcome Measures

Name	Time	Method
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16	Baseline, Week 16	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.
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).	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.
Adherence to Adalimumab Treatment	up to 16 weeks	Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
Mean Psoriasis Area and Severity Index (PASI) Score Over Time	Baseline, Week 4, Week 8, Week 16	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.
Mean Dermatology Life Quality Index (DLQI) Score Over Time	Baseline, Week 4, Week 8, Week 16	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.

Trial Locations

Locations (3): Site Reference ID/Investigator# 56700
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Lima, Peru
Site Reference ID/Investigator# 35783
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Lima, Peru
Site Reference ID/Investigator# 43147
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Trujillo, Peru