Intestinal Behcet's Disease (BD) Clinical Trial
— AMOREOfficial title:
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
| NCT number | NCT02687828 |
| Other study ID # | P15-760 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 18, 2016 |
| Est. completion date | March 30, 2020 |
| Verified date | March 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | March 30, 2020 |
| Est. primary completion date | March 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kosin University Gospel Hosp /ID# 169244 | Busan | |
| Korea, Republic of | Kyungpook National Univ Hosp /ID# 147937 | Daegu | Daegu Gwang Yeogsi |
| Korea, Republic of | The Catholic Univ. of Korea /ID# 169245 | Gyeonggi-do | |
| Korea, Republic of | Yonsei University Health System, Severance Hospital /ID# 147932 | Seodaemun-gu | Seoul Teugbyeolsi |
| Korea, Republic of | Asan Medical Center /ID# 147935 | Seoul | |
| 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 | Seoul National University Hospital /ID# 147933 | Seoul | |
| Korea, Republic of | Ajou University Hospital /ID# 147938 | Suwon-si | Gyeonggido |
| Korea, Republic of | Pusan Nat Univ Yangsan Hosp /ID# 169243 | Yangsan-si, | Gyeongsangnamdo |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events | All adverse events including serious and unexpected events will be assessed. | 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 | Number of participants with adverse drug reactions | All adverse reactions including serious and unexpected reactions will be assessed. | 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 |