N/A
N=28
Surveillance of Humira in Korean JIA Patients
Polyarticular Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02141984 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 6; 1; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 1; 1 | — |
| SECONDARY Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment |
-6.05 | — |
| SECONDARY Physician's Global Assessment of the Disease |
18; 1; 0; 0 | — |
| SECONDARY Parent's Global Assessment for Effectiveness |
19; 0; 0; 0 | — |
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.
Eligibility Criteria
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 exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02141984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.