Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

S
Stacey Tarvin, MD

Primary Investigator

Enrolling By Invitation
8-21 years
All
Phase N/A
198 participants needed
2 Locations

Brief description of study

This randomized pragmatic trial will generate knowledge about strategies used to de-escalateumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 29 participating pediatric healthcare systems. This open label study will be conducted in the setting of routined will compare the risk and timing of flare (Aim 1) and patients' lived(Aim 2) across three arms.

Detailed description of study

This project is a prospective, 12-month pragmatic randomized trial embedded within routine. Children with spondyloarthritis who have maintained inactive disease on ay prescribed standard dosing of a TNFi for 6 months or longer will be eligible for. Children will be randomized to one of the following alternative approaches:ued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), org TNFi (arm 3). The recommended visit frequency is every 3 months through the studydpoint at 12 months. After subjects have followed their treatment assignment for 12 months,hose 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 24dditional months for long-term outcomes after the intervention period.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Juvenile Spondyloarthritis, Riley
  • Age: Between 8 Years - 21 Years
  • Gender: All

Inclusion Criteria:
  1. Males or females age 8 to 21 years
  2. Juvenile SpA diagnosis (symptom onset before their 16th birthday):
    Pediatric Rheumatology International Trials Organization (PRINTO) revision of the TheLeague of Associations for Rheumatology (ILAR) criteriahesitis/spondylitis-related Juvenile idiopathic arthritis (JIA)
    • Peripheral arthritis and enthesitis, or
    • Arthritis or enthesitis, plus ≥ 3 months of inflammatory back pain andging, 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 adegree relative
  3. Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab,
    Etanercept, Golimumab, Infliximab) at standard doses and dosing intervals
  4. Have reached a clinically inactive disease state for a minimum of six months, asdetermined by treating physician
  5. English speaking or Spanish speaking
  6. Interested and willing to de-escalate TNFi therapy
Exclusion Criteria:
  1. History of inflammatory bowel disease, history of uveitis that was not adequatelyd with localized ophthalmic treatment or psoriasis that pre-dates the start ofTNFi therapy or psoriasis that started after TNFi therapy and has required more thanherapy for control

Updated on 14 Sep 2024. Study ID: 21-018442, PRHU-CHOP-BACK-OFF-JSPA, 17901
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