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NCT Number: NCT05411211

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

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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Key information

Conditions

Polyarticular Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Physician's Global Assessment (PhGA) of Participant's Disease Activity by Visual Analog Scale (VAS)

    Time frame: Up to 52 Weeks

    PhGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad.

  2. Change from Baseline in Participants Experiencing Joint Pain

    Time frame: Up to 52 Weeks

    Participants Experiencing Joint Pain

  3. Change from Baseline in Participants Experiencing Joint Swelling

    Time frame: Up to 52 Weeks

    Participants Experiencing Joint Swelling

  4. Number of Active Joints Count

    Time frame: Up to 52 Weeks

    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.

  5. Number of joints with limitation of passive motion (LOM)

    Time frame: Up to 52 Weeks

    Number of joints with LOM

  6. Number of joints with pain on passive motion (POM)

    Time frame: Up to 52 Weeks

    Number of joints with POM

  7. Change from Baseline of C-Reactive Protein (CRP) and/or Erythrocyte Sedimentation Rate (ESR) levels

    Time frame: Up to 52 Weeks

    CRP and/or ESR level assessed as part of the physician's site routine car

  8. Change from Baseline in Parent's or Child's Global Assessment of Participant's Disease Activity (Pa/ChGA) by Visual Analog Scale (VAS)

    Time frame: Up to 52 Weeks

    Pa/ChGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad.

  9. Change from Baseline in Physical function measured by Childhood Health Assessment Questionnaire (CHAQ)

    Time frame: Up to 52 Weeks

    The CHAQ assessed physical function. Scores go from 0= no disability to 3 = severe disability.

  10. Change from baseline in dosage of corticosteroid

    Time frame: Up to 52 Weeks

  11. Number of Participants with Adverse Events

    Time frame: Up to 52 Weeks

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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