Clinical trial NCT02687828: A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
Official title: A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Behcet's Disease (BD)
Keywords: Intestinal Behcet's disease (BD)
Adalimumab
Safety
Effectiveness
AMORE study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intestinal Behcet's disease (BD) patients who are eligible to be prescribed adalimumab by the treating investigator as per Korean label will be enrolled.

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 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
Secondary outcomes:
measure: Number of participants with adverse drug reactions
timeFrame: 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
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 147937
state: Daegu Gwang Yeogsi
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 147938
state: Gyeonggido
city: Yangsan-si,
country: Korea, Republic of
facility: Pusan Nat Univ Yangsan Hosp /ID# 169243
state: Gyeongsangnamdo
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital /ID# 147932
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 147934
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Cath Univ Seoul St Mary's Hosp /ID# 147936
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hosp /ID# 169244
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ. of Korea /ID# 169245
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 147933
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 147935
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: