A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
28 de outubro de 2015 atualizado por: Xian-Janssen Pharmaceutical Ltd.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of infliximab in Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine and rectum).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), placebo controlled (placebo is an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), double blind (neither investigator nor patient knows the treatment that the patient receives), 2-arm (2 groups), parallel group (a clinical study comparing the response in two or more groups of participants receiving different treatments) study with infliximab in patients with active ulcerative colitis.
The study consists of screening period (4 weeks prior to baseline [patient's medical status before any treatment or research is done] at Week 0), treatment period (Week 0 to Week 22) and follow up period (Week 26).
Participants completing treatment till Week 22 and benefit from continued treatment (in the opinion of the investigator) may enter a study extension period from Week 30 until Week 58.
Hundred participants will be randomized to 2 groups: Group 1 (50 participants receiving placebo) and Group 2 (50 participants receiving infliximab).
Effectiveness and safety (physical examination, and a review of AEs, vital signs, laboratory analyses, and concomitant medications) will be evaluated at Week 8 and Week 26 and at Week 58 (for participants who enter extension phase).
The maximum duration for participants in the main study is 26 weeks.
The maximum duration for participants including study extension is 58 weeks.
One of the specialized procedures used to calculate efficacy will be Mayo score which is calculated using the subscore (recorded in Mayo Diary Card by each participant) of the following 4 variables (1) stool frequency (scores ranging from 0 [normal number stools for this patient] to 3 [5 or more stools more than normal]), (2) rectal bleeding (scores ranging from 0 [no blood seen] to 3 [blood alone passed]), (3) endoscopic findings (scores ranging from 0 [normal or inactive disease] to 3 [severe disease ie, spontaneous bleeding and ulceration]), and (4) the physician's global assessment (scores ranging from 0 [normal] to 3 [severe disease]).
Tipo de estudo
Intervencional
Inscrição (Real)
99
Estágio
- Fase 3
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
-
-
-
Beijing, China
-
Chengdu, China
-
Guangzhou, China
-
Hefei, China
-
Shanghai, China
-
Wuhan, China
-
Xian, China
-
-
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 a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Has active ulcerative colitis of at least 3 months duration at screening with score of ≥2 on the endoscopy subscore of the Mayo score and baseline Mayo score of 6 to 12
- Concomitant medications: either have concurrent treatment with at least 1 of the therapies (eg, oral corticosteroids and 6-Mercaptopurine [6-MP]).
- Has to be eligible according to the tuberculosis (TB) eligibility assessment
Exclusion Criteria:
- Has severe extensive colitis or ulcerative colitis limited to only the rectum or to less than 20 cm of the colon
- Requires or required within 2 months prior to screening any surgery for active gastrointestinal bleeding, peritonitis (inflammation of abdominal lining), intestinal obstruction, or intra-abdominal or pancreatic abscess (a localized collection of pus in pancreas) requiring surgical drainage -Has severe fixed symptomatic stenosis (narrowing of the opening or hollow of any passage) of large or small intestine
- Has colonic obstruction or history within the 6 months prior to baseline
- Has colonic mucosal dysplasia (colonic mucosal cell maturation abnormality) or its history
- Has a history of extensive colonic resection (extensive partial removal of colon), lymphoproliferative disease (disease in which lymphocytes are produced in excessive quantities), demyelinating disease (disease of the nervous system)
- Has adenomatous colonic polyps (benign projecting mass of large intestine), stoma (opening either natural or surgically created connecting a portion of the body cavity to the outside environment), known infection of Human immunodeficiency virus (HIV), hepatitis B and C
- Has had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Group I: Placebo
Participants in Group I receive placebo
|
Form = solution for injection, route = IV, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with placebo through Week 22 will receive infliximab at Weeks 32, 34, 38, 46 and 54 and will receive placebo at Week 30.
|
|
Experimental: Group II: Infliximab
Participants in Group II receive 5 mg/kg infliximab
|
Form = solution for injection, route = intravenous (IV), Unit = mg/kg, number = 5, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with infliximab through Week 22 will receive infliximab at Weeks 30, 38, 46 and 54, and will receive placebo at Week 32 and 34.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with a clinical response at Week 8
Prazo: Week 8
|
At Week 8, clinical response is defined as a decrease from baseline (closest measurement taken prior to or at the time of the initiation of the baseline [Week 0] infusion) in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 8.
|
Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants in clinical remission at Week 8
Prazo: Week 8
|
A clinical remission at Week 8 is defined as a Mayo score ≤2 points, with no individual subscore >1.
Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
|
Week 8
|
|
Number of participants with mucosal healing at Week 8
Prazo: Week 8
|
Mucosal healing is determined from the endoscopy subscore of the Mayo score.
Mucosal healing will be defined by endoscopy subscore of 0 or 1.
|
Week 8
|
|
Number of participants with a clinical response at Week 26
Prazo: Week 26
|
At Week 26, clinical response is defined as decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 26.
|
Week 26
|
|
Number of participants in clinical remission at Week 26
Prazo: Week 26
|
A clinical remission at Week 26 is defined as a Mayo score ≤2 points, with no individual subscore >1.
Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
|
Week 26
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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.
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 abril de 2012
Conclusão Primária (Real)
1 de março de 2014
Conclusão do estudo (Real)
1 de outubro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
7 de março de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de março de 2012
Primeira postagem (Estimativa)
12 de março de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
30 de outubro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de outubro de 2015
Última verificação
1 de outubro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR018769
- REMICADEUCO3001 (Outro identificador: Xian-Janssen Pharmaceutical Ltd., China)
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 .