Clinical trial 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyarticular Juvenile Idiopathic Arthritis
Keywords: Polyarticular juvenile idiopathic arthritis
pJIA
adalimumab
Humira
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Physician's Global Assessment (PhGA) of Participant's Disease Activity by Visual Analog Scale (VAS)
timeFrame: Up to 52 Weeks
measure: Change from Baseline in Participants Experiencing Joint Pain
timeFrame: Up to 52 Weeks
measure: Change from Baseline in Participants Experiencing Joint Swelling
timeFrame: Up to 52 Weeks
measure: Number of Active Joints Count
timeFrame: Up to 52 Weeks
measure: Number of joints with limitation of passive motion (LOM)
timeFrame: Up to 52 Weeks
measure: Number of joints with pain on passive motion (POM)
timeFrame: Up to 52 Weeks
measure: Change from Baseline of C-Reactive Protein (CRP) and/or Erythrocyte Sedimentation Rate (ESR) levels
timeFrame: Up to 52 Weeks
measure: Change from Baseline in Parent's or Child's Global Assessment of Participant's Disease Activity (Pa/ChGA) by Visual Analog Scale (VAS)
timeFrame: Up to 52 Weeks
measure: Change from Baseline in Physical function measured by Childhood Health Assessment Questionnaire (CHAQ)
timeFrame: Up to 52 Weeks
measure: Change from baseline in dosage of corticosteroid
timeFrame: Up to 52 Weeks
measure: Number of Participants with Adverse Events
timeFrame: Up to 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Children's Hospital of Chongqing Medical University /ID# 232114
state: Chongqing
city: Wuhan
country: China
facility: Wuhan Children's Hospital /ID# 242274
state: Hubei
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: