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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Russian Federation
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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