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OpenTrials
Completed

NCT Number: NCT02687828

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

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

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Key information

Conditions

Intestinal Behcet's Disease (BD)

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National Univ Hosp /ID# 147937, Daegu, Daegu Gwang Yeogsi, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Acronym: AMORE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2016
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.