Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
Visão geral do estudo
Descrição detalhada
The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:
Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.
Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.
Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.
Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.
Exploratory objectives:
Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).
Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.
This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
-
London, Reino Unido
- Guy's & St Thomas' NHS Foundation Trust
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- Moderate-to-severe UC, defined as:
SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- Imminent need for colectomy (i.e. colectomy is being planned)
- Previous primary non-response to anti-TNF therapy in the opinion of the investigator
- Previous treatment with more than one anti-TNF therapy (excluding golimumab)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Induction cohort
Golimumab induction therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Outros nomes:
|
|
Outro: Maintenance cohort
Golimumab maintenance therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Serum Golimumab Concentration (μg/ml)
Prazo: Week 6 during induction therapy and at the point of study entry during maintenance
|
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
|
Week 6 during induction therapy and at the point of study entry during maintenance
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Patients in Clinical Remission
Prazo: Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Faecal Calprotectin (μg/g)
Prazo: Week 14 during induction therapy and at the point of study entry during maintenance
|
Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum C-Reactive Protein (mg/L)
Prazo: Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum Albumin (g/L)
Prazo: Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Clinical UC Disease Activity
Prazo: Week 14 during maintenance therapy and at the point of study entry during maintenance
|
Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
|
Week 14 during maintenance therapy and at the point of study entry during maintenance
|
|
Quality of Life (IBD-Control)
Prazo: Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Number of Patients With Detectable Anti-golimumab Antibodies
Prazo: At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
|
At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Gastroenterite
- Doenças do cólon
- Doenças Intestinais
- Doenças Inflamatórias Intestinais
- Colite
- Colite ulcerativa
- Efeitos Fisiológicos das Drogas
- Antiinflamatórios
- Agentes imunossupressores
- Fatores imunológicos
- Inibidores do Fator de Necrose Tumoral
- Golimumabe
Outros números de identificação do estudo
- 2017-001374-42
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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 .
Ensaios clínicos em Golimumab
-
Assiut UniversityAinda não está recrutandoDoença Inflamatória Intestinal (Crohn e Colite Ulcerosa)
-
Janssen Research & Development, LLCAtivo, não recrutandoDoença de CrohnEstados Unidos, Israel, Holanda, Canadá, Japão, Reino Unido, Bélgica, Taiwan, China, Alemanha, Hungria, Jordânia, Itália, Índia, Cingapura, Dinamarca, Malásia, Polônia, França, Suíça, Croácia, Estônia, Suécia, Nova Zelândia, Espanha, Austrália e mais
-
Janssen Research & Development, LLCAtivo, não recrutandoColite ulcerativaEstados Unidos, Israel, Holanda, Japão, Bélgica, Áustria, França, Hungria, Reino Unido, Jordânia, Índia, Taiwan, Dinamarca, Alemanha, Polônia, Itália, Suíça, Estônia, Canadá, Croácia, Austrália, Nova Zelândia, Argentina, Espanha, Brasil, Gr... e mais
-
Groupe d'Etude Therapeutique des Affections Inflammatoires...ConcluídoTratamento intensivo para atingir o alvo com golimumabe na colite ulcErativa - In-TARGET (In-TARGET)COLITE ULCERATIVAFrança, Bélgica
-
University of PennsylvaniaJanssen Scientific Affairs, LLCRecrutamentoArtrite psoriáticaEstados Unidos
-
Janssen Research & Development, LLCAtivo, não recrutandoColite ulcerativaEstados Unidos, Bélgica, Taiwan, Israel, França, Espanha, Brasil, Itália, Polônia, Holanda, Coréia do Sul
-
Janssen Research & Development, LLCConcluídoEspondilite anquilosanteEstados Unidos, Polônia, Ucrânia, Alemanha, Austrália, Canadá, Rússia, Coréia do Sul, México
-
Janssen Research & Development, LLCConcluídoArtrite, PsoriáticaEstados Unidos, Hungria, Dinamarca, Itália, França, Espanha, Ucrânia, Suécia, Polônia, Rússia
-
The Leeds Teaching Hospitals NHS TrustJanssen Pharmaceutica N.V., BelgiumConcluídoArtrite psoriáticaReino Unido
-
Professor Mikkel ØstergaardMerck Sharp & Dohme LLCConcluídoEspondiloartrite AxialDinamarca