Polyarticular Juvenile Arthritis Clinical Trial
— PETITEOfficial title:
Prospective Multi-Center Observational Study 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 (PETITE)
| NCT number | NCT03383263 |
| Other study ID # | P17-164 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 4, 2018 |
| Est. completion date | September 14, 2020 |
| Verified date | August 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | September 14, 2020 |
| Est. primary completion date | September 14, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of polyarticular Juvenile Idiopathic Arthritis (JIA) according to International League of Associations for Rheumatology (ILAR) criteria . - 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. - Negative result of tuberculosis (TB) screening procedure and TB specialist permission to start biologic therapy. - Patient's informed consent form signed by the parent or guardian/and by the child, if applicable. Exclusion Criteria: - Has contraindications for the treatment with HUMIRA according to the latest version of the locally approved label. - Any biologic drugs taken prior to 3 months of enrolment in the study. - Patients treated with any biosimilar version of HUMIRA - Previous participation and dropout from this study. - Patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Chelyabinsk Regional Children's Clinical Hospital /ID# 204829 | Chelyabinsk | Chelyabinskaya Oblast |
| Russian Federation | Kazan State Medical Academy /ID# 207004 | Kazan | |
| Russian Federation | Morozovskaya Children's City Clinical Hospital /ID# 207006 | Moscow | |
| Russian Federation | Sechenov First Moscow Medical /ID# 207005 | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874 | Mytischi | |
| Russian Federation | GBUZ NO Regional Children's Clinical Hospital /ID# 212362 | Nizhniy Novgorod | |
| Russian Federation | Privolzhsky Federal Medical Research Center /ID# 206318 | Nizhniy Novgorod | |
| Russian Federation | Regional Children's Clinical Hospital /ID# 206121 | Orenburg | |
| Russian Federation | Samara Regional Clinical Cardiology Clinic /ID# 206120 | Samara | |
| Russian Federation | Saint Petersburg State Pediatric Medical University /ID# 203169 | Sankt-Peterburg | |
| Russian Federation | Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361 | Saransk | |
| Russian Federation | Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319 | Saratov | Saratovskaya Oblast |
| Russian Federation | Republican Children's Clinical Hospital /ID# 204830 | Ufa | Bashkortostan, Respublika |
| Russian Federation | State Budgetary Health Institution "Regional Children's Clinical Hospital ?1" /ID# 212363 | Yekaterinburg |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Secondary | Proportion of patients with Humira adherence | The adherence to Humira will be assessed. | Up to Week 48 of treatment | |
| Secondary | Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Change from baseline in Erythrocyte Sedimentation Rate (ESR) | The Erythrocyte Sedimentation Rate is assessed. | From Week 0 to Week 48 of the treatment period | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Proportion of patients with any comorbidity | Patients with any comorbidities are assessed. | Up to 48 weeks of the treatment period |