- ICH GCP
- US Clinical Trials Registry
- 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®) (PETITE)
August 25, 2021 updated by: AbbVie
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)
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kazan, Russian Federation, 420012
- Kazan State Medical Academy /ID# 207004
-
Moscow, Russian Federation, 119049
- Morozovskaya Children's City Clinical Hospital /ID# 207006
-
Moscow, Russian Federation, 119992
- Sechenov First Moscow Medical /ID# 207005
-
Mytischi, Russian Federation, 141009
- State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874
-
Nizhniy Novgorod, Russian Federation, 603136
- GBUZ NO Regional Children's Clinical Hospital /ID# 212362
-
Nizhniy Novgorod, Russian Federation, 603155
- Privolzhsky Federal Medical Research Center /ID# 206318
-
Orenburg, Russian Federation, 460006
- Regional Children's Clinical Hospital /ID# 206121
-
Samara, Russian Federation, 443070
- Samara Regional Clinical Cardiology Clinic /ID# 206120
-
Sankt-Peterburg, Russian Federation, 194100
- Saint Petersburg State Pediatric Medical University /ID# 203169
-
Saransk, Russian Federation, 430005
- Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361
-
Yekaterinburg, Russian Federation, 620149
- State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363
-
-
Bashkortostan, Respublika
-
Ufa, Bashkortostan, Respublika, Russian Federation, 450106
- Republican Children's Clinical Hospital /ID# 204830
-
-
Chelyabinskaya Oblast
-
Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
- Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
-
-
Saratovskaya Oblast
-
Saratov, Saratovskaya Oblast, Russian Federation, 410012
- Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Children with juvenile arthritis
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 30 days after the last dose of the study drug (approximately 52 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with Humira adherence
Time Frame: Up to Week 48 of treatment
|
The adherence to Humira will be assessed.
|
Up to Week 48 of treatment
|
Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses
Time Frame: Up to Week 48 of treatment
|
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%.
|
Up to Week 48 of treatment
|
Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses
Time Frame: Up to Week 48 of treatment
|
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%.
|
Up to Week 48 of treatment
|
Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses
Time Frame: Up to Week 48 of treatment
|
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%.
|
Up to Week 48 of treatment
|
Change from baseline in physician overall disease activity
Time Frame: From Week 0 to Week 48 of the treatment period
|
This is measured using Visual Analog Scale (VAS).
|
From Week 0 to Week 48 of the treatment period
|
Change from baseline in patient (if appropriate in age) or parent overall well-being
Time Frame: From Week 0 to Week 48 of the treatment period
|
This is measured using Visual Analog Scale (VAS).
|
From Week 0 to Week 48 of the treatment period
|
Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score
Time Frame: Up to 48 weeks of the treatment period
|
Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score is assessed.
|
Up to 48 weeks of the treatment period
|
Change from baseline in number of joints with active arthritis
Time Frame: From Week 0 to Week 48 of the treatment period
|
The change in number of joints with active arthritis is assessed.
|
From Week 0 to Week 48 of the treatment period
|
Change from baseline in number of joints with limited range of motion
Time Frame: From Week 0 to Week 48 of the treatment period
|
The change in number of joints with limited range of motion is assessed.
|
From Week 0 to Week 48 of the treatment period
|
Change from baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame: From Week 0 to Week 48 of the treatment period
|
The Erythrocyte Sedimentation Rate is assessed.
|
From Week 0 to Week 48 of the treatment period
|
Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)
Time Frame: From Week 0 to Week 48 of the treatment period
|
10-joint Juvenile Arthritis Disease Activity Score is assessed.
|
From Week 0 to Week 48 of the treatment period
|
Proportion of patient with low diseases activity (1.1 - 2 score)
Time Frame: Up to 48 weeks of the treatment period
|
This is assessed based on JADAS10 score.
|
Up to 48 weeks of the treatment period
|
Proportion of patient with moderate disease activity (2.1 - 4.2 score)
Time Frame: Up to 48 weeks of the treatment period
|
This is assessed based on JADAS10 score.
|
Up to 48 weeks of the treatment period
|
Proportion of patients with missed dosed of HUMIRA
Time Frame: Up to 48 weeks of the treatment period
|
The proportion of patients with missed dosed of HUMIRA is assessed.
|
Up to 48 weeks of the treatment period
|
Proportion of patients with predefined Extra-articular manifestations (EAMs)
Time Frame: Up to 48 weeks of the treatment period
|
The proportion of patients with predefined EAMs is assessed.
|
Up to 48 weeks of the treatment period
|
Proportion of patients with any comorbidity
Time Frame: Up to 48 weeks of the treatment period
|
Patients with any comorbidities are assessed.
|
Up to 48 weeks of the treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2018
Primary Completion (Actual)
September 14, 2020
Study Completion (Actual)
September 14, 2020
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
December 26, 2017
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P17-164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polyarticular Juvenile Arthritis
-
Bristol-Myers SquibbCompletedActive Polyarticular Juvenile Idiopathic ArthritisUnited States, Spain, Belgium, Italy, Argentina, Brazil, France, Germany, Mexico, Peru, Russian Federation, South Africa
-
Chugai PharmaceuticalCompletedPolyarticular Juvenile Idiopathic Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
ItalfarmacoTerminatedPolyarticular Course Juvenile Idiopathic ArthritisBelgium, Spain, Serbia, Czech Republic, Italy, Romania, Slovenia
-
AbbVieRecruitingPolyarticular Juvenile Idiopathic ArthritisChina
-
Hackensack Meridian HealthPatient-Centered Outcomes Research Institute; The Hospital for Sick Children; University Health Network, Toronto and other collaboratorsCompletedPolyarticular Juvenile Rheumatoid Arthritis | Arthritis, Juvenile IdiopathicUnited States, Canada
-
UCB BIOSCIENCES GmbHPRA Health SciencesCompletedPolyarticular-course Juvenile Idiopathic Arthritis (JIA)United States, Argentina, Brazil, Canada, Chile, Mexico, Russian Federation
-
PfizerNot yet recruitingPolyarticular Juvenile Idiopathic Arthritis | Psoriatic Arthritis, JuvenileKorea, Republic of
-
Cairo UniversityCompletedFatigue | Rheumatic Diseases | Muscle Weakness | Juvenile Idiopathic Arthritis | Chronic Knee Pain | Polyarticular JCASaudi Arabia