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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessing Humira persistence | 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. | Up to 30 days after the last dose of the study drug (approximately 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Humira adherence | The adherence to Humira will be assessed. | Up to Week 48 of treatment |
| Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses |
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Inclusion Criteria:
Exclusion Criteria:
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Children with diagnosed polyarticular juvenile arthritis according to ILAR criteria treated with HUMIRA (adalimumab) in routine clinical settings in the Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Children's Clinical Hospital /ID# 204830 | Ufa | Bashkortostan Republic | 450106 | Russia | ||
| Chelyabinsk Regional Children's Clinical Hospital /ID# 204829 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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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%.
| Up to Week 48 of treatment |
| Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses | 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%. | Up to Week 48 of treatment |
| Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses | 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%. | Up to Week 48 of treatment |
| Change from baseline in physician overall disease activity | This is measured using Visual Analog Scale (VAS). | From Week 0 to Week 48 of the treatment period |
| Change from baseline in patient (if appropriate in age) or parent overall well-being | This is measured using Visual Analog Scale (VAS). | From Week 0 to Week 48 of the treatment period |
| Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score | Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score is assessed. | Up to 48 weeks of the treatment period |
| Change from baseline in number of joints with active arthritis | The change in number of joints with active arthritis is assessed. | From Week 0 to Week 48 of the treatment period |
| Change from baseline in number of joints with limited range of motion | The change in number of joints with limited range of motion is assessed. | From Week 0 to Week 48 of the treatment period |
| Change from baseline in Erythrocyte Sedimentation Rate (ESR) | The Erythrocyte Sedimentation Rate is assessed. | From Week 0 to Week 48 of the treatment period |
| Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10) | 10-joint Juvenile Arthritis Disease Activity Score is assessed. | From Week 0 to Week 48 of the treatment period |
| Proportion of patient with low diseases activity (1.1 - 2 score) | This is assessed based on JADAS10 score. | Up to 48 weeks of the treatment period |
| Proportion of patient with moderate disease activity (2.1 - 4.2 score) | This is assessed based on JADAS10 score. | Up to 48 weeks of the treatment period |
| Proportion of patients with missed dosed of HUMIRA | The proportion of patients with missed dosed of HUMIRA is assessed. | Up to 48 weeks of the treatment period |
| Proportion of patients with predefined Extra-articular manifestations (EAMs) | The proportion of patients with predefined EAMs is assessed. | Up to 48 weeks of the treatment period |
| Proportion of patients with any comorbidity | Patients with any comorbidities are assessed. | Up to 48 weeks of the treatment period |
| Chelyabinsk |
| Chelyabinsk Oblast |
| 454087 |
| Russia |
| Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319 | Saratov | Saratov Oblast | 410012 | Russia |
| Kazan State Medical Academy /ID# 207004 | Kazan' | 420012 | Russia |
| Morozovskaya Children's City Clinical Hospital /ID# 207006 | Moscow | 119049 | Russia |
| Sechenov First Moscow Medical /ID# 207005 | Moscow | 119992 | Russia |
| State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874 | Mytischi | 141009 | Russia |
| GBUZ NO Regional Children's Clinical Hospital /ID# 212362 | Nizhny Novgorod | 603136 | Russia |
| Privolzhsky Federal Medical Research Center /ID# 206318 | Nizhny Novgorod | 603155 | Russia |
| Regional Children's Clinical Hospital /ID# 206121 | Orenburg | 460006 | Russia |
| Saint Petersburg State Pediatric Medical University /ID# 203169 | Saint Petersburg | 194100 | Russia |
| Samara Regional Clinical Cardiology Clinic /ID# 206120 | Samara | 443070 | Russia |
| Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361 | Saransk | 430005 | Russia |
| State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363 | Yekaterinburg | 620149 | Russia |