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Completed

NCT Number: NCT03383263

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

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.

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Key information

Conditions

Polyarticular Juvenile Arthritis

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Republican Children's Clinical Hospital /ID# 204830, Ufa, Bashkortostan Republic, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of patients with Humira adherence

    Time frame: Up to Week 48 of treatment

    The adherence to Humira will be assessed.

  2. 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%.

  3. 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%.

  4. 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%.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Proportion of patients with any comorbidity

    Time frame: Up to 48 weeks of the treatment period

    Patients with any comorbidities are assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: PETITE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2017
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.