Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    198
  • sponsor
    Children's Hospital of Philadelphia
Updated on 8 January 2022

Summary

This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 21 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.

Description

This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months through the study endpoint at 12 months. After subjects have followed their treatment assignment for 12 months, those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.

Details
Condition Juvenile Spondyloarthritis
Treatment Standard TNFi Therapy, TNFi fixed longer dosing intervals, Stop TNFi treatment
Clinical Study IdentifierNCT04891640
SponsorChildren's Hospital of Philadelphia
Last Modified on8 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females age 8 to 21 years
Juvenile SpA diagnosis (symptom onset before their 16th birthday)
Pediatric Rheumatology International Trials Organization (PRINTO) revision of
the The International League of Associations for Rheumatology (ILAR) criteria
enthesitis/spondylitis-related Juvenile idiopathic arthritis (JIA)
Peripheral arthritis and enthesitis, or
Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain and sacroiliitis on imaging, or
Arthritis or enthesitis plus 2 of the following: (1) sacroiliac joint tenderness; (2) inflammatory back pain; (3) presence of Human leukocyte antigen (HLA-B27) ; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative
Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab
Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals
Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
English speaking
Interested and willing to de-escalate TNFi therapy

Exclusion Criteria

No history of uveitis, psoriasis, or inflammatory bowel disease
Clear my responses

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