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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: AbbVie

Current Primary Outcome: Number of participants with adverse events [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse drug reactions [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: February 17, 2016
Date Started: February 18, 2016
Date Completion: March 30, 2020
Last Updated: May 5, 2017
Last Verified: May 2017