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)

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung Univ Dongsan medical /ID# 138447
  • Daejeon, Korea, Republic of, 301-723
    • Daejeon St. Mary's Hospital /ID# 138445
  • Gwangju, Korea, Republic of, 61453
    • Chosun University Hospital /ID# 138454
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital /ID# 138446
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 138443
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong /ID# 138444
  • Seoul, Korea, Republic of, 100-032
    • Inje University Seoul Paik Hos /ID# 138452
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Med. Ctr. /ID# 138441
  • Daegu Gwang Yeogsi
    • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
      • Kyungpook National Univ Hosp /ID# 153133
  • Gyeonggido
    • Suwon, Gyeonggido, Korea, Republic of, 16247
      • St. Vincent's Hospital /ID# 138455
    • Suwon-si, Gyeonggido, Korea, Republic of, 16499
      • Ajou University Hospital /ID# 138457
  • Gyeongsangbugdo
    • Busan, Gyeongsangbugdo, Korea, Republic of, 47392
      • Inje University Busan Paik Hospital /ID# 138451
  • Incheon Gwang Yeogsi
    • Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
      • Inha University Hospital /ID# 150176
  • Jeonranamdo
    • Gwangju, Jeonranamdo, Korea, Republic of, 61469
      • Chonnam National University Hospital /ID# 138450
  • Seoul Teugbyeolsi
    • Dongdaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 02447
      • Kyung Hee University Medical Center /ID# 138453
    • Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
      • Kangbuk Samsung Hospital /ID# 150175
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Severance Hospital /ID# 138456
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 138449
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07061
      • SMG-SNU Boramae Medical Center /ID# 138448

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with moderate to severe ulcerative colitis (UC) receiving adalimumab per the Korean label.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Regarding Medicine Information

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): September 17, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Fecal Calprotectin; Adalimumab trough level; Fecal microbiota
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: P15-346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No