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

March 18, 2021 updated by: AbbVie
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hosp /ID# 169244
      • Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic Univ. of Korea /ID# 169245
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 147933
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 147935
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
        • Kyungpook National Univ Hosp /ID# 147937
    • Gyeonggido
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 147938
    • Gyeongsangnamdo
      • Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612
        • Pusan Nat Univ Yangsan Hosp /ID# 169243
    • Seoul Teugbyeolsi
      • Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital /ID# 147932
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 147934
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • Cath Univ Seoul St Mary's Hosp /ID# 147936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects receiving adalimumab
The subjects who are prescribed adalimumab for intestinal Behcet's disease (BD) in accordance with the approved Korean label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2016

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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