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)

AbbVie14 sites in 1 country70 target enrollmentMay 4, 2018

ConditionsPolyarticular Juvenile Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polyarticular Juvenile Arthritis
Sponsor: AbbVie
Enrollment: 70
Locations: 14
Primary Endpoint: Assessing Humira persistence
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 routine clinical settings in the Russian Federation.

Registry

clinicaltrials.gov

Start Date

May 4, 2018

End Date

September 14, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Assessing Humira persistence

Time Frame: Up to 30 days after the last dose of the study drug (approximately 52 weeks)

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.

Secondary Outcomes

Proportion of patients with Humira adherence(Up to Week 48 of treatment)
Change from baseline in patient (if appropriate in age) or parent overall well-being(From Week 0 to Week 48 of the treatment period)
Change from baseline in Erythrocyte Sedimentation Rate (ESR)(From Week 0 to Week 48 of the treatment period)
Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
Proportion of patients with predefined Extra-articular manifestations (EAMs)(Up to 48 weeks of the treatment period)
Proportion of patients with any comorbidity(Up to 48 weeks of the treatment period)
Change from baseline in number of joints with limited range of motion(From Week 0 to Week 48 of the treatment period)
Proportion of patient with low diseases activity (1.1 - 2 score)(Up to 48 weeks of the treatment period)
Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)(From Week 0 to Week 48 of the treatment period)
Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
Change from baseline in physician overall disease activity(From Week 0 to Week 48 of the treatment period)
Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score(Up to 48 weeks of the treatment period)
Change from baseline in number of joints with active arthritis(From Week 0 to Week 48 of the treatment period)
Proportion of patient with moderate disease activity (2.1 - 4.2 score)(Up to 48 weeks of the treatment period)
Proportion of patients with missed dosed of HUMIRA(Up to 48 weeks of the treatment period)