Clinical trial NCT03383263: A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyarticular Juvenile Arthritis
Keywords: Humira®
polyarticular juvenile arthritis
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with diagnosed polyarticular juvenile arthritis according to ILAR criteria treated with HUMIRA (adalimumab) in routine clinical settings in the Russian Federation.

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.


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.

Primary outcomes:
measure: Assessing Humira persistence
timeFrame: Up to 30 days after the last dose of the study drug (approximately 52 weeks)
Secondary outcomes:
measure: Proportion of patients with Humira adherence
timeFrame: Up to Week 48 of treatment
measure: Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses
timeFrame: Up to Week 48 of treatment
measure: Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses
timeFrame: Up to Week 48 of treatment
measure: Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses
timeFrame: Up to Week 48 of treatment
measure: Change from baseline in physician overall disease activity
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Change from baseline in patient (if appropriate in age) or parent overall well-being
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score
timeFrame: Up to 48 weeks of the treatment period
measure: Change from baseline in number of joints with active arthritis
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Change from baseline in number of joints with limited range of motion
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Change from baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)
timeFrame: From Week 0 to Week 48 of the treatment period
measure: Proportion of patient with low diseases activity (1.1 - 2 score)
timeFrame: Up to 48 weeks of the treatment period
measure: Proportion of patient with moderate disease activity (2.1 - 4.2 score)
timeFrame: Up to 48 weeks of the treatment period
measure: Proportion of patients with missed dosed of HUMIRA
timeFrame: Up to 48 weeks of the treatment period
measure: Proportion of patients with predefined Extra-articular manifestations (EAMs)
timeFrame: Up to 48 weeks of the treatment period
measure: Proportion of patients with any comorbidity
timeFrame: Up to 48 weeks of the treatment period
Other outcomes:
Locations:
city: Ufa
country: Russian Federation
facility: Republican Children's Clinical Hospital /ID# 204830
state: Bashkortostan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
state: Chelyabinskaya Oblast
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
state: Saratovskaya Oblast
city: Kazan
country: Russian Federation
facility: Kazan State Medical Academy /ID# 207004
city: Moscow
country: Russian Federation
facility: Morozovskaya Children's City Clinical Hospital /ID# 207006
city: Moscow
country: Russian Federation
facility: Sechenov First Moscow Medical /ID# 207005
city: Mytischi
country: Russian Federation
facility: State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874
city: Nizhniy Novgorod
country: Russian Federation
facility: GBUZ NO Regional Children's Clinical Hospital /ID# 212362
city: Nizhniy Novgorod
country: Russian Federation
facility: Privolzhsky Federal Medical Research Center /ID# 206318
city: Orenburg
country: Russian Federation
facility: Regional Children's Clinical Hospital /ID# 206121
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Cardiology Clinic /ID# 206120
city: Sankt-Peterburg
country: Russian Federation
facility: Saint Petersburg State Pediatric Medical University /ID# 203169
city: Saransk
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361
city: Yekaterinburg
country: Russian Federation
facility: State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: