Status:
COMPLETED
A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
Lead Sponsor:
AbbVie
Conditions:
Polyarticular Juvenile Arthritis
Eligibility:
All Genders
2-18 years
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 routi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 4 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 14 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03383263
Start Date
May 4 2018
End Date
September 14 2020
Last Update
August 30 2021
Active Locations (14)
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1
Republican Children's Clinical Hospital /ID# 204830
Ufa, Bashkortostan Republic, Russia, 450106
2
Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
3
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
Saratov, Saratov Oblast, Russia, 410012
4
Kazan State Medical Academy /ID# 207004
Kazan', Russia, 420012