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A Prospective Non-interventional Multicentre 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

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Disease Information

Descriptive Information
Brief Title † A Prospective Non-interventional Multicentre 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
Official Title † A Prospective Non-interventional Multicentre 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
Brief Summary This is a prospective, single country, multi-center study in Ulcerative Colitis (UC) patients treated with adalimumab. 200 subjects will be enrolled at approximately 20 sites. The baseline assessment should be performed prior to the first dose of adalimumab (Visit1). Study visits will be conducted at weeks 8, 16, 24, 32, 40, 48 and 56 in accordance with clinical practice. All subjects will have one Follow-up for safety approximately 70 days after the last dose of adalimumab
Detailed Description This is Observation study.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Percentage of subjects with clinical response at week 8
Secondary Outcome Measure † Percentage of subjects with clinical remission in week 8 responders
Condition † Ulcerative Colitis
Intervention †
Study Arms / Comparison Groups Subjects with Ulcerative Colitis Subject with active moderate-to-severe ulcerative colitis patients with Mayo score of ≥6 points and endoscopic sub-score of ≥2 points despite treatment with corticosteroids and/or immunosuppressants.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 147
Start Date † June 11, 2015
Completion Date July 30, 2018
Primary Completion Date July 30, 2018
Eligibility Criteria † Inclusion Criteria: - Subject must be an adult >= 19 years - Subject with active moderate-to-severe ulcerative colitis patients with Mayo score of ≥ 6 points and endoscopic sub-score of >= 2 points despite treatment with corticosteroids and/or immunosuppressants - Subjects must have tuberculosis (TB) Screening Assessment in accordance Korean reimbursement guideline - Subjects who are started on adalimumab treatment in normal clinical practice setting - Subject must provide written authorization form to use personal and/or health data prior to the entry into the study Exclusion Criteria: - Female subjects who are pregnant or breast feeding - Subject applies with any contraindication to adalimumab - Subject is participating in other clinical trials
Gender All
Ages 19 Years - 99 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT02499263
Organization ID P15-346
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † AbbVie
Collaborators ††
Investigators † Study Director: EunJung Gu, AbbVie Korea
Information Provided By
Verification Date June 2017
First Received Date † July 1, 2015
Last Updated Date June 8, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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