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

NCT05411211 | Completed

• 1 other identifier: P20-379
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Polyarticular Juvenile Idiopathic Arthritis

Keywords

Polyarticular juvenile idiopathic arthritis; pJIA; adalimumab; Humira

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Pediatric Participants receiving adalimumab

Pediatric Participants receiving adalimumab for polyarticular juvenile idiopathic arthritis (pJIA)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

The Children's Hospital of Chongqing Medical University /ID# 232114

Chongqing, Chongqing Municipality, 400065, China

Location

Wuhan Children's Hospital /ID# 242274

Wuhan, Hubei, 430000, China

Location

Related Links

• Related info
• clinical study report synopsis

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: November 10, 2022
• Primary Completion: September 8, 2024
• Study Completion: September 8, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (2)