A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
- Conditions
- Intestinal Behcet's Disease (BD)
- Registration Number
- NCT02687828
- Lead Sponsor
- AbbVie
- Brief Summary
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks All adverse events including serious and unexpected events will be assessed.
- Secondary Outcome Measures
Name Time Method Number of participants with adverse drug reactions From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks All adverse reactions including serious and unexpected reactions will be assessed.
Trial Locations
- Locations (10)
Pusan Nat Univ Yangsan Hosp /ID# 169243
🇰🇷Yangsan-si,, Gyeongsangnamdo, Korea, Republic of
Ajou University Hospital /ID# 147938
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Kyungpook National Univ Hosp /ID# 147937
🇰🇷Daegu, Daegu Gwang Yeogsi, Korea, Republic of
Yonsei University Health System, Severance Hospital /ID# 147932
🇰🇷Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of
Cath Univ Seoul St Mary's Hosp /ID# 147936
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 147934
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kosin University Gospel Hosp /ID# 169244
🇰🇷Busan, Korea, Republic of
The Catholic Univ. of Korea /ID# 169245
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital /ID# 147933
🇰🇷Seoul, Korea, Republic of
Asan Medical Center /ID# 147935
🇰🇷Seoul, Korea, Republic of