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

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ClinicalTrials.gov Identifier: NCT02687828
Recruitment Status : Active, not recruiting
First Posted : February 22, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Condition or disease
Intestinal Behcet's Disease (BD)

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : February 18, 2016
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020


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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687828


Locations
Korea, Republic of
Kyungpook National Univ Hosp /ID# 147937
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
Ajou University Hospital /ID# 147938
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Pusan Nat Univ Yangsan Hosp /ID# 169243
Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612
Severance Hospital, Yonsei University Health System /ID# 147932
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 147934
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Cath Univ Seoul St Mary's Hosp /ID# 147936
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Kosin University Gospel Hosp /ID# 169244
Busan, Korea, Republic of, 602-702
The Catholic Univ. of Korea /ID# 169245
Gyeonggi-do, Korea, Republic of, 16247
Seoul National University Hospital /ID# 147933
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 147935
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02687828     History of Changes
Other Study ID Numbers: P15-760
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Intestinal Behcet's disease (BD)
Adalimumab
Safety
Effectiveness
AMORE study

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents