Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

8 de agosto de 2014 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

Condições

Psoríase moderada a grave

Tipo de estudo

Observacional

Inscrição (Real)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Peru
- - Lima, Peru
    - Site Reference ID/Investigator# 35783
  - Lima, Peru
    - Site Reference ID/Investigator# 56700
  - Trujillo, Peru
    - Site Reference ID/Investigator# 43147

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

Grupo / Coorte

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response Prazo: 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.	Baseline to Week 16
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score Prazo: 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.	Baseline to Week 16

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 Prazo: 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.	Baseline, Week 16
Number of Participants With Serious Adverse Events (SAEs) Prazo: 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.	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 Prazo: 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.	up to 16 weeks
Mean Psoriasis Area and Severity Index (PASI) Score Over Time Prazo: 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.	Baseline, Week 4, Week 8, Week 16
Mean Dermatology Life Quality Index (DLQI) Score Over Time Prazo: 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.	Baseline, Week 4, Week 8, Week 16

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AbbVie (prior sponsor, Abbott)

Investigadores

Diretor de estudo: Manuel Uribe, MD, AbbVie

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Related Info

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2010

Conclusão Primária (Real)

1 de agosto de 2013

Conclusão do estudo (Real)