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Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting.
Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China.
Participants will receive adalimumab per their physician's usual prescription. Individual data will be collected for 52 weeks.
No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Participants receiving adalimumab | Pediatric Participants receiving adalimumab for polyarticular juvenile idiopathic arthritis (pJIA) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Physician's Global Assessment (PhGA) of Participant's Disease Activity by Visual Analog Scale (VAS) | PhGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad. | Up to 52 Weeks |
| Change from Baseline in Participants Experiencing Joint Pain | Participants Experiencing Joint Pain | Up to 52 Weeks |
| Change from Baseline in Participants Experiencing Joint Swelling | Participants Experiencing Joint Swelling | Up to 52 Weeks |
| Number of Active Joints Count | Active joints are defined as joints with swelling not due to deformity or joints with limitation of passive motion [LOM] and with pain and/or tenderness. Higher scores represent higher disease activity. | Up to 52 Weeks |
| Number of joints with limitation of passive motion (LOM) | Number of joints with LOM | Up to 52 Weeks |
| Number of joints with pain on passive motion (POM) | Number of joints with POM | Up to 52 Weeks |
| Change from Baseline of C-Reactive Protein (CRP) and/or Erythrocyte Sedimentation Rate (ESR) levels | CRP and/or ESR level assessed as part of the physician's site routine car | Up to 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Chongqing Medical University /ID# 232114 | Chongqing | Chongqing Municipality | 400065 | China | ||
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| Label | URL |
|---|---|
| Related info | View source |
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| Change from Baseline in Parent's or Child's Global Assessment of Participant's Disease Activity (Pa/ChGA) by Visual Analog Scale (VAS) | Pa/ChGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad. | Up to 52 Weeks |
| Change from Baseline in Physical function measured by Childhood Health Assessment Questionnaire (CHAQ) | The CHAQ assessed physical function. Scores go from 0= no disability to 3 = severe disability. | Up to 52 Weeks |
| Change from baseline in dosage of corticosteroid | Up to 52 Weeks |
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. | Up to 52 Weeks |
| Wuhan Children's Hospital /ID# 242274 |
| Wuhan |
| Hubei |
| 430000 |
| China |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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