A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients

NCT ID: NCT02687828

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-18

Study Completion Date

2020-03-30

Brief Summary

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This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.

Detailed Description

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Conditions

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Intestinal Behcet's Disease (BD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects receiving adalimumab

The subjects who are prescribed adalimumab for intestinal Behcet's disease (BD) in accordance with the approved Korean label.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects must be an adult \>= 19 years
* Subjects who are eligible to be treated with adalimumab for intestinal Behcet's disease in accordance with the approved label in Korea
* Subjects provide written authorization form for use/disclose of personal health data prior to participating in this study

Exclusion Criteria

* Subjects who are contraindicated to any anti-TNF agent
* Female subjects who are pregnant or breast feeding
* Subjects who are participating in other interventional clinical trials
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Kyungpook National Univ Hosp /ID# 147937

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Ajou University Hospital /ID# 147938

Suwon, Gyeonggido, South Korea

Site Status

Pusan Nat Univ Yangsan Hosp /ID# 169243

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Yonsei University Health System, Severance Hospital /ID# 147932

Seodaemun-gu, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 147934

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Cath Univ Seoul St Mary's Hosp /ID# 147936

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Kosin University Gospel Hosp /ID# 169244

Busan, , South Korea

Site Status

The Catholic Univ. of Korea /ID# 169245

Gyeonggi-do, , South Korea

Site Status

Seoul National University Hospital /ID# 147933

Seoul, , South Korea

Site Status

Asan Medical Center /ID# 147935

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P15-760

Identifier Type: -

Identifier Source: org_study_id

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