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

Ulcerative Colitis Clinical Trial

— EUREKA  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499263
• Other study ID #: P15-346
• Status: Completed
• Start date: June 11, 2015
• Est. completion date: September 17, 2018

Study information

• Verified date: October 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital /ID# 138451	Busan	Gyeongsangbugdo
Korea, Republic of	Keimyung Univ Dongsan medical /ID# 138447	Daegu
Korea, Republic of	Kyungpook National Univ Hosp /ID# 153133	Daegu	Daegu Gwang Yeogsi
Korea, Republic of	Daejeon St. Mary's Hospital /ID# 138445	Daejeon
Korea, Republic of	Kyung Hee University Medical Center /ID# 138453	Dongdaemun-gu	Seoul Teugbyeolsi
Korea, Republic of	Chonnam National University Hospital /ID# 138450	Gwangju	Jeonranamdo
Korea, Republic of	Chosun University Hospital /ID# 138454	Gwangju
Korea, Republic of	Kangbuk Samsung Hospital /ID# 150175	Jongno-Gu	Seoul Teugbyeolsi
Korea, Republic of	Inha University Hospital /ID# 150176	Jung-gu	Incheon Gwang Yeogsi
Korea, Republic of	Chung-Ang University Med. Ctr. /ID# 138441	Seoul
Korea, Republic of	Ewha Womans University Mokdong /ID# 138444	Seoul
Korea, Republic of	Inje University Seoul Paik Hos /ID# 138452	Seoul
Korea, Republic of	Korea University Anam Hospital /ID# 138446	Seoul
Korea, Republic of	Samsung Medical Center /ID# 138449	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 138443	Seoul
Korea, Republic of	Severance Hospital /ID# 138456	Seoul	Seoul Teugbyeolsi
Korea, Republic of	SMG-SNU Boramae Medical Center /ID# 138448	Seoul	Seoul Teugbyeolsi
Korea, Republic of	St. Vincent's Hospital /ID# 138455	Suwon	Gyeonggido
Korea, Republic of	Ajou University Hospital /ID# 138457	Suwon-si	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56	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.	Week 56
Primary	Percentage of Participants With 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 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
Primary	Percentage of Participants With Clinical Response at Week 24	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.	Week 24
Primary	Percentage of Participants With Clinical Response at 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.	Week 56
Secondary	Percentage of Participants With Clinical Remission at 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.	Week 8
Secondary	Percentage of Participants With Clinical Remission at 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.	Week 56
Secondary	Percentage of Participants Who Were Week 8 Responders With Clinical Remission at 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.	Week 8
Secondary	Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56	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.	Week 56
Secondary	Percentage of Participants With Steroid-free Remission at Week 8	Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment.	Week 8
Secondary	Percentage of Participants With Steroid-free Remission at 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.	Week 56
Secondary	Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at 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
Secondary	Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at 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.	Week 56
Secondary	Percentage of Participants With Steroid-free Response at 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
Secondary	Percentage of Participants With Steroid-free Response at 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
Secondary	Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at 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
Secondary	Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at 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
Secondary	Percentage of Participants With Mucosal Healing at 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
Secondary	Percentage of Participants With Mucosal Healing at 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
Secondary	Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at 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
Secondary	Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at 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
Secondary	Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56	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
Secondary	Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders 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 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
Secondary	Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders 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 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 56
Secondary	Fecal Calprotectin Level at Week 8	Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.	Week 8
Secondary	Fecal Calprotectin Level at Week 56	Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.	Week 56
Secondary	Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8	Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.	Week 8
Secondary	Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8	Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.	Week 56
Secondary	Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at 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 PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.	Week 8
Secondary	Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at 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.	Week 56
Secondary	Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56	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.	Week 0, Week 8, Week 56

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