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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-11

Study Completion Date

2018-09-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No