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

AbbVie70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Polyarticular Juvenile Arthritis

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Republican Children's Clinical Hospital /ID# 204830

Ufa, Bashkortostan Republic, Russia

Chelyabinsk Regional Children's Clinical Hospital /ID# 204829

Chelyabinsk, Chelyabinsk Oblast, Russia

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Proportion of patients with Humira adherence

The adherence to Humira will be assessed.

Time frame: Up to Week 48 of treatment

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%.

Time frame: Up to Week 48 of treatment

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%.

Time frame: Up to Week 48 of treatment

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%.

Time frame: Up to Week 48 of treatment

Change from baseline in physician overall disease activity

This is measured using Visual Analog Scale (VAS).

Time frame: From Week 0 to Week 48 of the treatment period

Data from ClinicalTrials.gov

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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

...and 4 more locations

Change from baseline in patient (if appropriate in age) or parent overall well-being

This is measured using Visual Analog Scale (VAS).

Time frame: From Week 0 to Week 48 of the treatment period

Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score

Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score is assessed.

Time frame: Up to 48 weeks of the treatment period

Change from baseline in number of joints with active arthritis

The change in number of joints with active arthritis is assessed.

Time frame: From Week 0 to Week 48 of the treatment period

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.

Time frame: From Week 0 to Week 48 of the treatment period

Change from baseline in Erythrocyte Sedimentation Rate (ESR)

The Erythrocyte Sedimentation Rate is assessed.

Time frame: From Week 0 to Week 48 of the treatment period

Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)

10-joint Juvenile Arthritis Disease Activity Score is assessed.

Time frame: From Week 0 to Week 48 of the treatment period

Proportion of patient with low diseases activity (1.1 - 2 score)

This is assessed based on JADAS10 score.

Time frame: Up to 48 weeks of the treatment period

Proportion of patient with moderate disease activity (2.1 - 4.2 score)

This is assessed based on JADAS10 score.

Time frame: Up to 48 weeks of the treatment period

Proportion of patients with missed dosed of HUMIRA

The proportion of patients with missed dosed of HUMIRA is assessed.

Time frame: Up to 48 weeks of the treatment period

Proportion of patients with predefined Extra-articular manifestations (EAMs)

The proportion of patients with predefined EAMs is assessed.

Time frame: Up to 48 weeks of the treatment period

Proportion of patients with any comorbidity

Patients with any comorbidities are assessed.

Time frame: Up to 48 weeks of the treatment period