A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®) (PETITE)

AbbVie

Status: Completed

Conditions: Polyarticular Juvenile Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03383263

P17-164

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

Children with juvenile arthritis

Description:

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