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Trial record 4 of 36 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis, Juvenile Rheumatoid"

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

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ClinicalTrials.gov Identifier: NCT03383263
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease
Polyarticular Juvenile Arthritis

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383263


Contacts
Contact: Andrey Potapov +7 960 820 20 57 andrey.potapov@abbvie.com
Contact: Olesya Magdych +7 909 641 16 93 olesya.magdych@abbvie.com

Locations
Russian Federation
Republican Children's Clinical Hospital /ID# 204830 Not yet recruiting
Ufa, Bashkortostan, Respublika, Russian Federation, 450106
Chelyabinsk Regional Children's Clinical Hospital /ID# 204829 Not yet recruiting
Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319 Not yet recruiting
Saratov, Saratovskaya Oblast, Russian Federation, 410012
Kazan State Medical Academy /ID# 207004 Not yet recruiting
Kazan, Russian Federation, 420012
Morozovskaya Children's City Clinical Hospital /ID# 207006 Not yet recruiting
Moscow, Russian Federation, 119049
Sechenov First Moscow Medical /ID# 207005 Not yet recruiting
Moscow, Russian Federation, 119992
Privolzhsky Federal Medical Research Center /ID# 206318 Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603155
Regional Children's Clinical Hospital /ID# 206121 Not yet recruiting
Orenburg, Russian Federation, 460006
Samara Regional Clinical Cardiology Clinic /ID# 206120 Not yet recruiting
Samara, Russian Federation, 443070
Saint Petersburg State Pediatric Medical University /ID# 203169 Recruiting
Sankt-Peterburg, Russian Federation, 194100
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03383263     History of Changes
Other Study ID Numbers: P17-164
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Humira®
polyarticular juvenile arthritis
Adalimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents