Pediatric Crohn's DiseaseNCT02578238
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
An observational study of Pediatric Crohn's Disease, run by AbbVie.
Trial summary
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Crohn's Disease
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2015to 31 May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric CD patients who have been prescribed Humira® by the treating physician
Who may be able to join
- Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
- Patients who have given written authorization to use their personal health data for the purposes of this study.
Who cannot join
- Any contraindications to Humira as listed on the approved product market authorization (labeling)
- Patients who is participating on other clinical trials.
About this study
Official title: Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
- Conditions
- Pediatric Crohn's Disease
- Keywords
- Korea, Humira, Pediatric Crohn's Disease
- Medical subject headings
- Pediatric Crohn's disease
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 |
|---|---|---|
| Participants With Pediatric CD | Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.
Measured: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start24 Sep 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Crohn's DiseaseStudies 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eunjung Gu, MS, Study director, AbbVie korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578238
- Sponsor's protocol ID
- P15-619
- Status last verified
- May 2018
- First submitted
- 15 Oct 2015
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"
- ClinicalTrials.gov ID
- NCT02578238
- Acronym / sponsor ID
- P15-619
- Conditions
- Pediatric Crohn's Disease
- Keywords
- Korea, Humira, Pediatric Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Pediatric CD | – | –Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric CD patients who have been prescribed Humira® by the treating physician
Key inclusion criteria (2 listed)
- Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
- Patients who have given written authorization to use their personal health data for the purposes of this study.
Key exclusion criteria (2 listed)
- Any contraindications to Humira as listed on the approved product market authorization (labeling)
- Patients who is participating on other 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
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
Time frame: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Regarding Medicine InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Eunjung Gu, MS study director
AbbVie korea
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Crohn's Disease, run by AbbVie.
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 2 inclusion and 2 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs (time frame: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).). 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 19 Dec 2018.