Polyarticular Juvenile Idiopathic Arthritis
Conditions
Keywords
Korean regulatory required Postmarketing Surveillance
Brief 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. 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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) | 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. |
| Physician's Global Assessment of the Disease | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) | The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' |
| Parent's Global Assessment for Effectiveness | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) | Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' |
Participant flow
Recruitment details
A total of 600 participants were expected to enroll in the study; however, due to low prevalence of JIA and ERA, only 28 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Polyarticular JIA or ERA Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Patients With Polyarticular JIA or ERA |
|---|---|
| Age, Continuous | 17.68 years STANDARD_DEVIATION 5.69 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
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.
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)
Population: Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Polyarticular JIA or ERA | Number of Participants With Adverse Events | Unexpected AE | 1 participants |
| Patients With Polyarticular JIA or ERA | Number of Participants With Adverse Events | Any AE | 6 participants |
| Patients With Polyarticular JIA or ERA | Number of Participants With Adverse Events | Any SAE | 1 participants |
Secondary
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.
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Polyarticular JIA or ERA | Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment | -6.05 active joint | Standard Deviation 6.65 |
Secondary
Parent's Global Assessment for Effectiveness
Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Polyarticular JIA or ERA | Parent's Global Assessment for Effectiveness | Improved | 19 Participants |
| Patients With Polyarticular JIA or ERA | Parent's Global Assessment for Effectiveness | Not changed | 0 Participants |
| Patients With Polyarticular JIA or ERA | Parent's Global Assessment for Effectiveness | Aggravated | 0 Participants |
| Patients With Polyarticular JIA or ERA | Parent's Global Assessment for Effectiveness | Not assessable | 0 Participants |
Secondary
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.'
Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Population: Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Polyarticular JIA or ERA | Physician's Global Assessment of the Disease | Improved | 18 participants |
| Patients With Polyarticular JIA or ERA | Physician's Global Assessment of the Disease | Not changed | 1 participants |
| Patients With Polyarticular JIA or ERA | Physician's Global Assessment of the Disease | Aggravated | 0 participants |
| Patients With Polyarticular JIA or ERA | Physician's Global Assessment of the Disease | Not assessable | 0 participants |