Intestinal Behcet's Disease (BD)AMORENCT02687828
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
An observational study of Intestinal Behcet's Disease (BD), run by AbbVie at 10 sites in South Korea.
Trial summary
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Intestinal Behcet's Disease (BD)
- How many people
- 59 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 18 Feb 2016to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Kosin University Gospel Hosp /ID# 169244
Busan, 49267
Kyungpook National Univ Hosp /ID# 147937
Daegu, Daegu Gwang Yeogsi, 41944
The Catholic Univ. of Korea /ID# 169245
Gyeonggi-do, 16247
Yonsei University Health System, Severance Hospital /ID# 147932
Seodaemun-gu, Seoul Teugbyeolsi, 03722
Samsung Medical Center /ID# 147934
Seoul, Seoul Teugbyeolsi, 06351
Cath Univ Seoul St Mary's Hosp /ID# 147936
Seoul, Seoul Teugbyeolsi, 06591
Seoul National University Hospital /ID# 147933
Seoul, 03080
Asan Medical Center /ID# 147935
Seoul, 05505
Ajou University Hospital /ID# 147938
Suwon, Gyeonggido, 16499
Pusan Nat Univ Yangsan Hosp /ID# 169243
Yangsan, Gyeongsangnam-do, 50612
About this study
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.
- Conditions
- Intestinal Behcet's Disease (BD)
- Keywords
- Intestinal Behcet's disease (BD), Adalimumab, Safety, Effectiveness, AMORE study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving adalimumab | The subjects who are prescribed adalimumab for intestinal Behcet's disease (BD) in accordance with the approved Korean label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
All adverse events including serious and unexpected events will be assessed.
Measured: 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 outcomes (1)
Number of participants with adverse drug reactions
All adverse reactions including serious and unexpected reactions will be assessed.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start18 Feb 2016
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Behcet's Disease (BD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687828
- Sponsor's protocol ID
- P15-760
- Acronym
- AMORE
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2016
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02687828
- Acronym / sponsor ID
- AMORE / P15-760
- Conditions
- Intestinal Behcet's Disease (BD)
- Keywords
- Intestinal Behcet's disease (BD), Adalimumab, Safety, Effectiveness, AMORE study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving adalimumab | – | –The subjects who are prescribed adalimumab for intestinal Behcet's disease (BD) in accordance with the approved Korean label. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Behcet's Disease (BD), run by AbbVie at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.