Polyarticular Juvenile Idiopathic ArthritisNCT05411211
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 observational study of Polyarticular Juvenile Idiopathic Arthritis, run by AbbVie at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Polyarticular Juvenile Idiopathic Arthritis
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 10 Nov 2022to 8 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Children's Hospital of Chongqing Medical University /ID# 232114
Chongqing, Chongqing Municipality, 400065
Wuhan Children's Hospital /ID# 242274
Wuhan, Hubei, 430000
About this study
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
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.
Read more
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.
- Keywords
- Polyarticular juvenile idiopathic arthritis, pJIA, adalimumab, Humira
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Participants receiving adalimumab | Pediatric Participants receiving adalimumab for polyarticular juvenile idiopathic arthritis (pJIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 52 Weeks
Change from Baseline in Participants Experiencing Joint Pain
Participants Experiencing Joint Pain
Measured: Up to 52 Weeks
Change from Baseline in Participants Experiencing Joint Swelling
Participants Experiencing Joint Swelling
Measured: 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.
Measured: Up to 52 Weeks
Number of joints with limitation of passive motion (LOM)
Number of joints with LOM
Measured: Up to 52 Weeks
Number of joints with pain on passive motion (POM)
Number of joints with POM
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 52 Weeks
Change from baseline in dosage of corticosteroid
Measured: 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.
Measured: Up to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start10 Nov 2022
- Primary completion8 Sep 2024
- Study completion8 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyarticular Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411211
- Sponsor's protocol ID
- P20-379
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05411211
- Acronym / sponsor ID
- P20-379
- Keywords
- Polyarticular juvenile idiopathic arthritis, pJIA, adalimumab, Humira
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Participants receiving adalimumab | – | –Pediatric Participants receiving adalimumab for polyarticular juvenile idiopathic arthritis (pJIA) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Chinese Pediatric Participants with Polyarticular juvenile idiopathic arthritis (pJIA)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Change from Baseline in Participants Experiencing Joint Pain
Time frame: Up to 52 Weeks
Participants Experiencing Joint Pain
Change from Baseline in Participants Experiencing Joint Swelling
Time frame: Up to 52 Weeks
Participants Experiencing Joint Swelling
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.
Number of joints with limitation of passive motion (LOM)
Time frame: Up to 52 Weeks
Number of joints with LOM
Number of joints with pain on passive motion (POM)
Time frame: Up to 52 Weeks
Number of joints with POM
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
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.
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.
Change from baseline in dosage of corticosteroid
Time frame: Up to 52 Weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyarticular Juvenile Idiopathic Arthritis, run by AbbVie at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.