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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02687828

Acronym

AMORE

Enrollment

Registered

2016-02-22

Start date

2016-02-18

Completion date

2020-03-30

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Behcet's Disease (BD)

Keywords

Intestinal Behcet's disease (BD), Adalimumab, Safety, Effectiveness, AMORE study

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results