Polyarticular Juvenile Idiopathic ArthritisNCT02141984
Surveillance of Humira in Korean JIA Patients
An observational study of Polyarticular Juvenile Idiopathic Arthritis, run by AbbVie.
Trial summary
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Polyarticular Juvenile Idiopathic Arthritis
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Apr 2016
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General hospital
Who may be able to join
- Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
- Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate
- Patients who give written authorization form to use their personal and health data from legal parents or representative.
- Physician will refer to the product market authorization (label) for inclusion criteria.
Who cannot join
- Patients with known hypersensitivity to Humira or any of its excipients.
- Patients who is participating on other clinical trials.
- Physician will refer to the product market authorization (label) for exclusion criteria.
About this study
Official title: Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.
- Keywords
- Korean regulatory required Postmarketing Surveillance
- Medical subject headings
- Arthritis, Juvenile
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 |
|---|---|---|
| Patients with Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)
Secondary outcomes (3)
Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment
Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.
Measured: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Physician's Global Assessment of the Disease
The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'
Measured: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Parent's Global Assessment for Effectiveness
Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'
Measured: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
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 Polyarticular Juvenile Idiopathic ArthritisStudies 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
- 28 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
- NCT02141984
- Sponsor's protocol ID
- P14-362
- Status last verified
- Apr 2017
- First submitted
- 16 May 2014
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination
- ClinicalTrials.gov ID
- NCT02141984
- Acronym / sponsor ID
- P14-362
- Keywords
- Korean regulatory required Postmarketing Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 23 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Polyarticular JIA or ERA | – | –Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General hospital
Key inclusion criteria (4 listed)
- Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
- Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate
- Patients who give written authorization form to use their personal and health data from legal parents or representative.
- Physician will refer to the product market authorization (label) for inclusion criteria.
Key exclusion criteria (3 listed)
- Patients with known hypersensitivity to Humira or any of its excipients.
- Patients who is participating on other clinical trials.
- Physician will refer to the product market authorization (label) for exclusion criteria.
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: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
3 secondary outcomes
Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Physician's Global Assessment of the Disease
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Parent's Global Assessment for Effectiveness
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Polyarticular Juvenile Idiopathic Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
RecruitingPhase 3
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
Not yet recruitingPhase 1
A Study to Evaluate Pharmacokinetics of DRL_AB in Healthy Male Participants
Healthy Volunteers
RecruitingObservational study
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Psoriatic Arthritis, Juvenile, Polyarticular Juvenile Idiopathic Arthritis
Active, not recruitingPhase 1
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
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 Polyarticular Juvenile Idiopathic Arthritis, 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 4 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 23 Jun 2017. 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 23 Jun 2017). 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?
Number of Participants With Adverse Events (time frame: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 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 23 Jun 2017.