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

Polyarticular Juvenile Idiopathic Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411211
• Other study ID #: P20-379
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: June 26, 2024

Study information

• Verified date: August 2023
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Male or female participants aged 2-17 years old with body weight = 10kg.
• Diagnosis of polyarticular JIA by treating physician.
• Adalimumab (Humira®) treatment is indicated as per treatment according to Chinese label.
• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Polyarticular Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
China	Children's Hospital Affiliated to Chongqing Medical University /ID# 232114	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline in Participants Experiencing Joint Pain	Participants Experiencing Joint Pain	Up to 52 Weeks
Primary	Change from Baseline in Participants Experiencing Joint Swelling	Participants Experiencing Joint Swelling	Up to 52 Weeks
Primary	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
Primary	Number of joints with limitation of passive motion (LOM)	Number of joints with LOM	Up to 52 Weeks
Primary	Number of joints with pain on passive motion (POM)	Number of joints with POM	Up to 52 Weeks
Primary	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
Primary	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
Primary	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
Primary	Change from baseline in dosage of corticosteroid		Up to 52 Weeks
Primary	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

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