Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
2014년 8월 8일 업데이트: AbbVie (prior sponsor, Abbott)
Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
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.
연구 개요
상태
종료됨
정황
연구 유형
관찰
등록 (실제)
30
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Lima, 페루
- Site Reference ID/Investigator# 35783
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Lima, 페루
- Site Reference ID/Investigator# 56700
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Trujillo, 페루
- Site Reference ID/Investigator# 43147
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Adalimumab Treatment in Participants with Psoriasis
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
기간: Baseline to Week 16
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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.
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Baseline to Week 16
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Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
기간: Baseline to Week 16
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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.
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Baseline to Week 16
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
기간: Baseline, Week 16
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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.
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Baseline, Week 16
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Number of Participants With Serious Adverse Events (SAEs)
기간: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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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.
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From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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Adherence to Adalimumab Treatment
기간: up to 16 weeks
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Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
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up to 16 weeks
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Mean Psoriasis Area and Severity Index (PASI) Score Over Time
기간: Baseline, Week 4, Week 8, Week 16
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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.
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Baseline, Week 4, Week 8, Week 16
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Mean Dermatology Life Quality Index (DLQI) Score Over Time
기간: Baseline, Week 4, Week 8, Week 16
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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.
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Baseline, Week 4, Week 8, Week 16
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Manuel Uribe, MD, AbbVie
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 11월 1일
기본 완료 (실제)
2013년 8월 1일
연구 완료 (실제)
2013년 8월 1일
연구 등록 날짜
최초 제출
2010년 7월 1일
QC 기준을 충족하는 최초 제출
2010년 7월 1일
처음 게시됨 (추정)
2010년 7월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 8월 8일
마지막으로 확인됨
2014년 8월 1일
추가 정보
이 연구와 관련된 용어
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