Polyarticular Juvenile ArthritisPETITENCT03383263
A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)
An observational study of Polyarticular Juvenile Arthritis, run by AbbVie at 14 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Polyarticular Juvenile Arthritis
- How many people
- 70 participants
- Where
- 14 sitesRussia
- Study dates
- 4 May 2018to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with diagnosed polyarticular juvenile arthritis according to ILAR criteria treated with HUMIRA (adalimumab) in routine clinical settings in the Russian Federation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
Chelyabinsk, Chelyabinsk Oblast, 454087
Kazan State Medical Academy /ID# 207004
Kazan', 420012
Morozovskaya Children's City Clinical Hospital /ID# 207006
Moscow, 119049
Sechenov First Moscow Medical /ID# 207005
Moscow, 119992
State Budgetary Healthcare Institution Moscow Region "Moscow Regional Consultati /ID# 212874
Mytischi, 141009
GBUZ NO Regional Children's Clinical Hospital /ID# 212362
Nizhny Novgorod, 603136
Privolzhsky Federal Medical Research Center /ID# 206318
Nizhny Novgorod, 603155
Regional Children's Clinical Hospital /ID# 206121
Orenburg, 460006
Saint Petersburg State Pediatric Medical University /ID# 203169
Saint Petersburg, 194100
Samara Regional Clinical Cardiology Clinic /ID# 206120
Samara, 443070
Federal State Budgetary Educational Institution of Higher Education National Re /ID# 212361
Saransk, 430005
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
Saratov, Saratov Oblast, 410012
Republican Children's Clinical Hospital /ID# 204830
Ufa, Bashkortostan Republic, 450106
State Budgetary Health Institution "Regional Children's Clinical Hospital №1" /ID# 212363
Yekaterinburg, 620149
About this study
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)
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.
- Conditions
- Polyarticular Juvenile Arthritis
- Keywords
- Humira®, polyarticular juvenile arthritis, Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after the last dose of the study drug (approximately 52 weeks)
Secondary outcomes (16)
Proportion of patients with Humira adherence
The adherence to Humira will be assessed.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: Up to Week 48 of treatment
Change from baseline in physician overall disease activity
This is measured using Visual Analog Scale (VAS).
Measured: From Week 0 to Week 48 of the treatment period
Change from baseline in patient (if appropriate in age) or parent overall well-being
This is measured using Visual Analog Scale (VAS).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Week 0 to Week 48 of the treatment period
Change from baseline in Erythrocyte Sedimentation Rate (ESR)
The Erythrocyte Sedimentation Rate is assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 48 weeks of the treatment period
Proportion of patients with any comorbidity
Patients with any comorbidities are assessed.
Measured: Up to 48 weeks of the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start4 May 2018
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyarticular Juvenile ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383263
- Sponsor's protocol ID
- P17-164
- Acronym
- PETITE
- Status last verified
- Aug 2021
- First submitted
- 18 Dec 2017
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03383263
- Acronym / sponsor ID
- PETITE / P17-164
- Conditions
- Polyarticular Juvenile Arthritis
- Keywords
- Humira®, polyarticular juvenile arthritis, Adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 May 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with diagnosed polyarticular juvenile arthritis according to ILAR criteria treated with HUMIRA (adalimumab) in routine clinical settings in the Russian Federation.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
16 secondary outcomes
Proportion of patients with Humira adherence
Time frame: 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
Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses
Time frame: 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
Change from baseline in physician overall disease activity
Time frame: 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
Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score
Time frame: 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
Change from baseline in number of joints with limited range of motion
Time frame: 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
Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)
Time frame: 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
Proportion of patient with moderate disease activity (2.1 - 4.2 score)
Time frame: 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
Proportion of patients with predefined Extra-articular manifestations (EAMs)
Time frame: Up to 48 weeks of the treatment period
Proportion of patients with any comorbidity
Time frame: Up to 48 weeks of the treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyarticular Juvenile Arthritis, run by AbbVie at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Humira persistence (time frame: Up to 30 days after the last dose of the study drug (approximately 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.