Ensaio clínico em Colite ulcerativa - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Concluído

Condições

Colite ulcerativa

Tipo de estudo

Observacional

Inscrição (Real)

100

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

Canadá
- Alberta
  - Calgary, Alberta, Canadá, T2N 4Z6
    - University of Calgary /ID# 144032
  - Edmonton, Alberta, Canadá, T6G 2X8
    - Zeidler Ledcor Centre /ID# 145973
- British Columbia
  - New Westminster, British Columbia, Canadá, V3L 3W5
    - Columbia Gastro Mgmnt Ltd /ID# 136820
  - Vancouver, British Columbia, Canadá, V6Z 2K5
    - GIRI Gastrointestinal Research Institute /ID# 141107
  - Victoria, British Columbia, Canadá, V8T 5G4
    - Discovery Clinical Services /ID# 144102
  - Victoria, British Columbia, Canadá, V8V 3M9
    - Percuro Clinical Research, Ltd /ID# 136533
- New Brunswick
  - Fredericton, New Brunswick, Canadá, E3B 5N5
    - Dr. Everett Chalmers Reg Hosp. /ID# 136534
  - St. John, New Brunswick, Canadá, E2K 1J5
    - Dr Chadwick Ian Williams Professional Corporation /ID# 144802
- Ontario
  - Brampton, Ontario, Canadá, L6S 0C1
    - Bellini Medicine Professional /ID# 144241
  - Oshawa, Ontario, Canadá, L1H 1B9
    - Oshawa Clinic /ID# 144364
  - Ottawa, Ontario, Canadá, K1H 8L6
    - The Ottawa Hospital /ID# 139392
  - Toronto, Ontario, Canadá, M53 TA9
    - Kensington Screening Clinic /ID# 141106
  - Toronto, Ontario, Canadá, M5G 1X5
    - Mount Sinai Hosp.-Toronto /ID# 141108
  - Windsor, Ontario, Canadá, N8W 1E6
    - Dr O Tarabain Medicine Prof Corp /ID# 144034
  - Windsor, Ontario, Canadá, N8Y 4C9
    - Dr. Rahman Bacchus Med. Corp. /ID# 141780
- Quebec
  - Levis, Quebec, Canadá, G6V 3Z1
    - Hopital Hotel-Dieu de Levis /ID# 137099
  - Montreal, Quebec, Canadá, H1T 2M4
    - Hospital Maisonneuve-Rosemont /ID# 137336
  - Montreal, Quebec, Canadá, H2X 3J4
    - CHUM - Hopital Saint-Luc /ID# 139393
  - Montreal, Quebec, Canadá, H3G 1A4
    - McGill Univ HC /ID# 136821
  - Montreal, Quebec, Canadá, H3P 3E5
    - Clinique MEDI-CLE /ID# 153690
  - Quebec City, Quebec, Canadá, G1R 2J6
    - CHU de Quebec-Universite Laval /ID# 147557
  - Sherbrooke, Quebec, Canadá, J1H 5N4
    - CHUS - Hopital Fleurimont /ID# 137840
- Saskatchewan
  - Saskatoon, Saskatchewan, Canadá, S7N 0W8
    - Royal Univ. Hosp, Saskatoon,CA /ID# 137838

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

Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.

Descrição

Inclusion Criteria:

Patient must voluntarily sign and date a patient authorization.
Patient must be ≥ 18 years of age.
Patient must have confirmed diagnosis of UC.
Patient must have:
1. a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
2. a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr.
Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.

Exclusion Criteria:

Patient has previously received adalimumab.
Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
Patient with other tumor necrosis factor (TNF) immune-modulated disease.
Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
A female patient is pregnant or breast-feeding.
Patient is currently participating in another prospective study including controlled clinical trials and observational studies

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

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

Número de grupos/coortes

1

Coortes e Intervenções

Grupo / Coorte
Open-label cohort Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change from baseline in depressive symptoms at Week 52 Prazo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change from baseline in depressive symptoms at Week 8 Prazo: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in the proportion of patients with PHQ-9 >= 10 Prazo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Disability Prazo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Overall quality of life Prazo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Ulcerative Colitis (UC)-specific quality of life Prazo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fatigue Prazo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Sleep impairment, Prazo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Work productivity Prazo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The change from baseline in work productivity is assessed at week 8 and 52.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Assessing Simple Clinical Colitis Activity Index (SCCAI) Prazo: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	SCCAI is used to access response and remission rates.	Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fecal Calprotectin levels Prazo: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The change from baseline in Fecal Calprotectin levels will be assessed.	From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score Prazo: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	Mayo endoscopic sub-score will be assessed.	Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients with Complications including hospitalization and surgery Prazo: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The proportion of patients with complications including hospitalization and surgery will be assessed.	At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients on steroids Prazo: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The proportion of patients on steroids will be assessed.	At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Physician's Global Assessment (PGA) Prazo: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation	The change from baseline in Physician's Global Assessment (PGA) will be assessed.	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Colaboradores e Investigadores

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

Patrocinador

AbbVie

Colaboradores

Cato Research

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

clinical study report synopsis

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 (Real)

18 de agosto de 2015

Conclusão Primária (Real)

10 de fevereiro de 2020

Conclusão do estudo (Real)

10 de fevereiro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de julho de 2015

Primeira postagem (Estimativa)

23 de julho de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de janeiro de 2021

Última verificação

1 de janeiro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

P15-325

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Indeciso

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)

A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)