A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice (EUREKA)
9 de outubro de 2019 atualizado por: AbbVie
A Prospective Multicenter Study to Observe the Effectiveness on Ulcerative Colitis and Predictive Factors of Clinical Response in Korean Patients Treated With Adalimumab (EUREKA Study)
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab.
Up to 147 participants are enrolled at approximately 20 sites.
The baseline assessment is performed prior to the first dose of adalimumab (Visit 1).
Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice.
All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a prospective, single-country, multi-center study in UC patients treated with adalimumab. The prescription of adalimumab is at the discretion of the physician in accordance with clinical practice and label, is made independently from this study, and preceded the decision to offer the patient the opportunity to participate in this study.
Up to 147 subjects are planned to be enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Participants are administered adalimumab 160 mg at Week 0, 80 mg at Week 2, and then 40 mg every other week per the Korean label. Study visits are conducted at Weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants had one Follow-up for safety approximately 70 days after the last dose of adalimumab.
Clinical response is assessed at Week 8, and participants with clinical response at Week 8 can continue on adalimumab treatment as per Korean reimbursement guidelines. Clinical response is defined as a decrease from baseline in the total Mayo score by at least 3 points and at least 30% with an accompanying decrease in rectal bleeding subscore of at least 1 point or absolute rectal bleeding sub-score of 0 or 1.
Tipo de estudo
Observacional
Inscrição (Real)
150
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
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Daegu, Republica da Coréia, 700-712
- Keimyung Univ Dongsan medical /ID# 138447
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Daejeon, Republica da Coréia, 301-723
- Daejeon St. Mary's Hospital /ID# 138445
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Gwangju, Republica da Coréia, 61453
- Chosun University Hospital /ID# 138454
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Seoul, Republica da Coréia, 02841
- Korea University Anam Hospital /ID# 138446
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Seoul, Republica da Coréia, 03080
- Seoul National University Hospital /ID# 138443
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Seoul, Republica da Coréia, 07985
- Ewha Womans University Mokdong /ID# 138444
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Seoul, Republica da Coréia, 100-032
- Inje University Seoul Paik Hos /ID# 138452
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Seoul, Republica da Coréia, 156-755
- Chung-Ang University Med. Ctr. /ID# 138441
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Daegu Gwang Yeogsi
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Daegu, Daegu Gwang Yeogsi, Republica da Coréia, 41944
- Kyungpook National Univ Hosp /ID# 153133
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Gyeonggido
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Suwon, Gyeonggido, Republica da Coréia, 16247
- St. Vincent's Hospital /ID# 138455
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Suwon-si, Gyeonggido, Republica da Coréia, 16499
- Ajou University Hospital /ID# 138457
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Gyeongsangbugdo
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Busan, Gyeongsangbugdo, Republica da Coréia, 47392
- Inje University Busan Paik Hospital /ID# 138451
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Incheon Gwang Yeogsi
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Jung-gu, Incheon Gwang Yeogsi, Republica da Coréia, 22332
- Inha University Hospital /ID# 150176
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Jeonranamdo
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Gwangju, Jeonranamdo, Republica da Coréia, 61469
- Chonnam National University Hospital /ID# 138450
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Seoul Teugbyeolsi
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Dongdaemun-gu, Seoul Teugbyeolsi, Republica da Coréia, 02447
- Kyung Hee University Medical Center /ID# 138453
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Jongno-Gu, Seoul Teugbyeolsi, Republica da Coréia, 03181
- Kangbuk Samsung Hospital /ID# 150175
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Seoul, Seoul Teugbyeolsi, Republica da Coréia, 03722
- Severance Hospital /ID# 138456
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Seoul, Seoul Teugbyeolsi, Republica da Coréia, 06351
- Samsung Medical Center /ID# 138449
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Seoul, Seoul Teugbyeolsi, Republica da Coréia, 07061
- SMG-SNU Boramae Medical Center /ID# 138448
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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
19 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Participants with moderate to severe ulcerative colitis (UC) receiving adalimumab per the Korean label.
Descrição
Inclusion Criteria:
- Participant must be an adult ≥19 years
- Participant with active moderate to severe ulcerative colitis with Mayo score of ≥ 6 points and endoscopic sub-score of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants.
- Participant must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guidelines.
- Participants who had started on adalimumab treatment in normal clinical practice setting by their physician.
- Participant must provide written authorization form to use personal and/or health data prior to the entry into the study.
Exclusion Criteria:
- Female participants who are pregnant or breast feeding
- Participant with any contraindication to adalimumab
- Participant that is participating in other clinical trials
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: Caso-somente
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Participants with Ulcerative Colitis (UC)
Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label in participants with active moderate-to-severe UC.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56
Prazo: Week 56
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Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56.
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants With Clinical Response at Week 8
Prazo: Week 8
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Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants With Clinical Response at Week 24
Prazo: Week 24
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Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 24
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Percentage of Participants With Clinical Response at Week 56
Prazo: Week 56
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Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With Clinical Remission at Week 8
Prazo: Week 8
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Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants With Clinical Remission at Week 56
Prazo: Week 56
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Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8
Prazo: Week 8
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Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56
Prazo: Week 56
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Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56.
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants With Steroid-free Remission at Week 8
Prazo: Week 8
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Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment.
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Week 8
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Percentage of Participants With Steroid-free Remission at Week 56
Prazo: Week 56
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Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.
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Week 56
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Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8
Prazo: Week 8
|
Steroid-free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56
Prazo: Week 56
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Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants With Steroid-free Response at Week 8
Prazo: Week 8
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Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment.
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants With Steroid-free Response at Week 56
Prazo: Week 56
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Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment.
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8
Prazo: Week 8
|
Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment (in Week 8 clinical responders).Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56
Prazo: Week 56
|
Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 12 weeks prior to assessment (in Week 8 clinical responders).
A participant was a Week 8 responder if they had a clinical response at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Percentage of Participants With Mucosal Healing at Week 8
Prazo: Week 8
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Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at week 8. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease. |
Week 8
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Percentage of Participants With Mucosal Healing at Week 56
Prazo: Week 56
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Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease. |
Week 56
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Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8
Prazo: Week 8
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Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 8. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease).
Negative change in Mayo score indicates improvement.
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Week 8
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Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56
Prazo: Week 56
|
Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56.
Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease).
Negative change in Mayo score indicates improvement.
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Week 56
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Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
Prazo: Baseline, Week 8
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The partial Mayo score is based on the Mayo score, which is a tool designed to measure disease activity for ulcerative colitis. The partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in partial Mayo score indicates improvement. |
Baseline, Week 8
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Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
Prazo: Baseline, Week 8
|
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
|
Baseline, Week 8
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Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56
Prazo: Baseline, Week 56
|
Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Baseline, Week 56
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Fecal Calprotectin Level at Week 8
Prazo: Week 8
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
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Week 8
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Fecal Calprotectin Level at Week 56
Prazo: Week 56
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
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Week 56
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Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8
Prazo: Week 8
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
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Week 8
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Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8
Prazo: Week 56
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
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Week 56
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Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56
Prazo: Week 8
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 8
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Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56
Prazo: Week 56
|
Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease).
A negative change in Mayo score indicates improvement.
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Week 56
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Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56
Prazo: Week 0, Week 8, Week 56
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Composition of fecal microbiota (16S ribosomal ribonucleic acid (rRNA) gene sequencing) was measured at Week 0, Week 8, and Week 56.
Fecal bacterial composition was determined using 16S sequencing.
The obtained sequences were analyzed using the Ezbiocloud database and 16S microbiome pipeline to assess composition and diversity.
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Week 0, Week 8, Week 56
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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.
Links úteis
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)
11 de junho de 2015
Conclusão Primária (Real)
17 de setembro de 2018
Conclusão do estudo (Real)
17 de setembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
1 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de julho de 2015
Primeira postagem (Estimativa)
16 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de novembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de outubro de 2019
Última verificação
1 de outubro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P15-346
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
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