An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)

An Open-label, Multi-center, Post-marketing, Observational Study to Assess the Effectiveness and Safety of Adalimumab (Humira®) in Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis (pJIA) in China

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.

Study Overview

• Status: Completed
• Conditions: Polyarticular Juvenile Idiopathic Arthritis

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400065
      • The Children's Hospital of Chongqing Medical University /ID# 232114
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan Children's Hospital /ID# 242274

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)

Description

Inclusion Criteria:

• Male or female participants aged 2-17 years old with body weight ≥ 10kg.
• Diagnosis of polyarticular pJIA by treating physician.
• Adalimumab (Humira®) treatment is indicated as per Chinese label and according to judgement of the physician to Chinese clinical practice guidelines for the diagnosis and treatment of juvenile idiopathic arthritis.
• Participants or their parents/legal guardians are able and willing to give assent as well as informed consent approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, and to comply with the requirements of this study protocol and Adalimumab (Humira ®) label.

Exclusion Criteria:

• Participants who cannot be treated with adalimumab according to Chinese Humira® label and by judgement of treating physician.
• Participants who receive any biological disease-modifying anti-rheumatic drugs (bDMARDs) within 6 months prior to the screening visit or who are on concomitant use of any bDMARD.
• Post menarche adolescent female subjects who are pregnant or breastfeeding or considering becoming pregnant during the study
• Participant is considered by the investigator or sub-investigator, for any reason, to be an unsuitable candidate for the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric Participants receiving adalimumab; Pediatric Participants receiving adalimumab for polyarticular juvenile idiopathic arthritis (pJIA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info
• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): September 8, 2024
• Study Completion (Actual): September 8, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: adalimumab; Humira; Polyarticular juvenile idiopathic arthritis; pJIA
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: P20-379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No