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 ottobre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
150
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Daegu, Corea, Repubblica di, 700-712
- Keimyung Univ Dongsan medical /ID# 138447
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Daejeon, Corea, Repubblica di, 301-723
- Daejeon St. Mary's Hospital /ID# 138445
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Gwangju, Corea, Repubblica di, 61453
- Chosun University Hospital /ID# 138454
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Seoul, Corea, Repubblica di, 02841
- Korea University Anam Hospital /ID# 138446
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Seoul, Corea, Repubblica di, 03080
- Seoul National University Hospital /ID# 138443
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Seoul, Corea, Repubblica di, 07985
- Ewha Womans University Mokdong /ID# 138444
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Seoul, Corea, Repubblica di, 100-032
- Inje University Seoul Paik Hos /ID# 138452
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Seoul, Corea, Repubblica di, 156-755
- Chung-Ang University Med. Ctr. /ID# 138441
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Daegu Gwang Yeogsi
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Daegu, Daegu Gwang Yeogsi, Corea, Repubblica di, 41944
- Kyungpook National Univ Hosp /ID# 153133
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Gyeonggido
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Suwon, Gyeonggido, Corea, Repubblica di, 16247
- St. Vincent's Hospital /ID# 138455
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Suwon-si, Gyeonggido, Corea, Repubblica di, 16499
- Ajou University Hospital /ID# 138457
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Gyeongsangbugdo
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Busan, Gyeongsangbugdo, Corea, Repubblica di, 47392
- Inje University Busan Paik Hospital /ID# 138451
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Incheon Gwang Yeogsi
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Jung-gu, Incheon Gwang Yeogsi, Corea, Repubblica di, 22332
- Inha University Hospital /ID# 150176
-
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Jeonranamdo
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Gwangju, Jeonranamdo, Corea, Repubblica di, 61469
- Chonnam National University Hospital /ID# 138450
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Seoul Teugbyeolsi
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Dongdaemun-gu, Seoul Teugbyeolsi, Corea, Repubblica di, 02447
- Kyung Hee University Medical Center /ID# 138453
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Jongno-Gu, Seoul Teugbyeolsi, Corea, Repubblica di, 03181
- Kangbuk Samsung Hospital /ID# 150175
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Seoul, Seoul Teugbyeolsi, Corea, Repubblica di, 03722
- Severance Hospital /ID# 138456
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Seoul, Seoul Teugbyeolsi, Corea, Repubblica di, 06351
- Samsung Medical Center /ID# 138449
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Seoul, Seoul Teugbyeolsi, Corea, Repubblica di, 07061
- SMG-SNU Boramae Medical Center /ID# 138448
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
19 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Participants with moderate to severe ulcerative colitis (UC) receiving adalimumab per the Korean label.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56
Lasso di tempo: 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
Lasso di tempo: Week 8
|
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
Lasso di tempo: 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
Lasso di tempo: Week 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 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants With Clinical Remission at Week 8
Lasso di tempo: Week 8
|
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
Lasso di tempo: Week 56
|
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
Lasso di tempo: Week 8
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 56
|
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
Lasso di tempo: 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.
|
Week 8
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Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56
Lasso di tempo: Week 56
|
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
Lasso di tempo: 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.
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.
|
Week 8
|
|
Percentage of Participants With Steroid-free Response at Week 56
Lasso di tempo: Week 56
|
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.
|
Week 56
|
|
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8
Lasso di tempo: 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.
|
Week 8
|
|
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56
Lasso di tempo: 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.
|
Week 56
|
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Percentage of Participants With Mucosal Healing at Week 8
Lasso di tempo: Week 8
|
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
Lasso di tempo: 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 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
|
|
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8
Lasso di tempo: Week 8
|
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.
|
Week 8
|
|
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56
Lasso di tempo: 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.
|
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
Lasso di tempo: Baseline, Week 8
|
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
|
|
Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 8
|
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.
|
Week 8
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Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 giugno 2015
Completamento primario (Effettivo)
17 settembre 2018
Completamento dello studio (Effettivo)
17 settembre 2018
Date di iscrizione allo studio
Primo inviato
1 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
14 luglio 2015
Primo Inserito (Stima)
16 luglio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 novembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 ottobre 2019
Ultimo verificato
1 ottobre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P15-346
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Indeciso
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .