A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
NCT ID: NCT03383263
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2018-05-04
2020-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
* 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.
2 Years
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Republican Children's Clinical Hospital /ID# 204830
Ufa, Bashkortostan Republic, Russia
Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
Chelyabinsk, Chelyabinsk Oblast, Russia
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
Saratov, Saratov Oblast, Russia
Kazan State Medical Academy /ID# 207004
Kazan', , Russia
Morozovskaya Children's City Clinical Hospital /ID# 207006
Moscow, , Russia
Sechenov First Moscow Medical /ID# 207005
Moscow, , Russia
State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874
Mytischi, , Russia
GBUZ NO Regional Children's Clinical Hospital /ID# 212362
Nizhny Novgorod, , Russia
Privolzhsky Federal Medical Research Center /ID# 206318
Nizhny Novgorod, , Russia
Regional Children's Clinical Hospital /ID# 206121
Orenburg, , Russia
Saint Petersburg State Pediatric Medical University /ID# 203169
Saint Petersburg, , Russia
Samara Regional Clinical Cardiology Clinic /ID# 206120
Samara, , Russia
Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361
Saransk, , Russia
State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363
Yekaterinburg, , Russia
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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P17-164
Identifier Type: -
Identifier Source: org_study_id
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