PETITE: A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
Study Details
Study Description
Brief Summary
The objective of this study is to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (HUMIRA®) in the routine clinical settings in the Russian Federation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children with juvenile arthritis Children with diagnosed polyarticular juvenile arthritis according to International League of Associations for Rheumatology (ILAR) criteria treated with HUMIRA (adalimumab) in the routine clinical settings in the Russian Federation |
Outcome Measures
Primary Outcome Measures
- Assessing Humira persistence [Up to 30 days after the last dose of the study drug (approximately 52 weeks)]
Persistence is defined as the time (in days) between the start date of HUMIRA (adalimumab) treatment and the earliest date of discontinuation of Humira (adalimumab) or drop out of study, or lost to follow up.
Secondary Outcome Measures
- Proportion of patients with Humira adherence [Up to Week 48 of treatment]
The adherence to Humira will be assessed.
- Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses [Up to Week 48 of treatment]
It is defined as 30% improvement respectively in a minimum of three core set criteria with worsening of one variable by no more than 30%.
- Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses [Up to Week 48 of treatment]
It is defined as 50% improvement respectively in a minimum of three core set criteria with worsening of one variable by no more than 30%.
- Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses [Up to Week 48 of treatment]
It is defined as 70% improvement respectively in a minimum of three core set criteria with worsening of one variable by no more than 30%.
- Change from baseline in physician overall disease activity [From Week 0 to Week 48 of the treatment period]
This is measured using Visual Analog Scale (VAS).
- Change from baseline in patient (if appropriate in age) or parent overall well-being [From Week 0 to Week 48 of the treatment period]
This is measured using Visual Analog Scale (VAS).
- Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score [Up to 48 weeks of the treatment period]
Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score is assessed.
- Change from baseline in number of joints with active arthritis [From Week 0 to Week 48 of the treatment period]
The change in number of joints with active arthritis is assessed.
- Change from baseline in number of joints with limited range of motion [From Week 0 to Week 48 of the treatment period]
The change in number of joints with limited range of motion is assessed.
- Change from baseline in Erythrocyte Sedimentation Rate (ESR) [From Week 0 to Week 48 of the treatment period]
The Erythrocyte Sedimentation Rate is assessed.
- Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10) [From Week 0 to Week 48 of the treatment period]
10-joint Juvenile Arthritis Disease Activity Score is assessed.
- Proportion of patient with low diseases activity (1.1 - 2 score) [Up to 48 weeks of the treatment period]
This is assessed based on JADAS10 score.
- Proportion of patient with moderate disease activity (2.1 - 4.2 score) [Up to 48 weeks of the treatment period]
This is assessed based on JADAS10 score.
- Proportion of patients with missed dosed of HUMIRA [Up to 48 weeks of the treatment period]
The proportion of patients with missed dosed of HUMIRA is assessed.
- Proportion of patients with predefined Extra-articular manifestations (EAMs) [Up to 48 weeks of the treatment period]
The proportion of patients with predefined EAMs is assessed.
- Proportion of patients with any comorbidity [Up to 48 weeks of the treatment period]
Patients with any comorbidities are assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed diagnosis of polyarticular Juvenile Idiopathic Arthritis (JIA) according to International League of Associations for Rheumatology (ILAR) criteria .
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Planned treatment with HUMIRA according to the local product label and prescription guidelines. Alternatively, subjects assigned to HUMIRA treatment not more than 1 month prior to inclusion can be enrolled.
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Negative result of tuberculosis (TB) screening procedure and TB specialist permission to start biologic therapy.
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Patient's informed consent form signed by the parent or guardian/and by the child, if applicable.
Exclusion Criteria:
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Has contraindications for the treatment with HUMIRA according to the latest version of the locally approved label.
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Any biologic drugs taken prior to 3 months of enrolment in the study.
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Patients treated with any biosimilar version of HUMIRA
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Previous participation and dropout from this study.
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Patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Republican Children's Clinical Hospital /ID# 204830 | Ufa | Bashkortostan, Respublika | Russian Federation | 450106 |
| 2 | Chelyabinsk Regional Children's Clinical Hospital /ID# 204829 | Chelyabinsk | Chelyabinskaya Oblast | Russian Federation | 454087 |
| 3 | Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319 | Saratov | Saratovskaya Oblast | Russian Federation | 410012 |
| 4 | Kazan State Medical Academy /ID# 207004 | Kazan | Russian Federation | 420012 | |
| 5 | Morozovskaya Children's City Clinical Hospital /ID# 207006 | Moscow | Russian Federation | 119049 | |
| 6 | Sechenov First Moscow Medical /ID# 207005 | Moscow | Russian Federation | 119992 | |
| 7 | State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874 | Mytischi | Russian Federation | 141009 | |
| 8 | GBUZ NO Regional Children's Clinical Hospital /ID# 212362 | Nizhniy Novgorod | Russian Federation | 603136 | |
| 9 | Privolzhsky Federal Medical Research Center /ID# 206318 | Nizhniy Novgorod | Russian Federation | 603155 | |
| 10 | Regional Children's Clinical Hospital /ID# 206121 | Orenburg | Russian Federation | 460006 | |
| 11 | Samara Regional Clinical Cardiology Clinic /ID# 206120 | Samara | Russian Federation | 443070 | |
| 12 | Saint Petersburg State Pediatric Medical University /ID# 203169 | Sankt-Peterburg | Russian Federation | 194100 | |
| 13 | Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361 | Saransk | Russian Federation | 430005 | |
| 14 | State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363 | Yekaterinburg | Russian Federation | 620149 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P17-164