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

Purpose

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 29 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.

Condition

  • Juvenile Spondyloarthritis

Eligibility

Eligible Ages
Between 8 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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 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, as determined 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 adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
TNFi Standard Therapy
Continue fixed standard treatment (i.e., no change from current therapy)
  • Other: Standard TNFi Therapy
    Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.
Experimental
TNFi fixed longer dosing intervals
Fixed longer dosing intervals of TNFi (i.e., increased time between doses)
  • Other: TNFi fixed longer dosing intervals
    Participants randomly assigned to this arm will increase the time between TNFi medication doses. - Adalimumab- from every 2 to 3 weeks - Certolizumab- from every 2 to 4 weeks - Etanercept- from every 1 to 2 weeks - Golimumab- from every 4 to 6 weeks - Infliximab- from baseline to baseline + 2 weeks
Experimental
TNFi Therapy Withdrawal
Stop TNFi treatment
  • Other: Stop TNFi treatment
    Participants randomly assigned to this arm will stop TNFi medication.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Children's Hospital of Philadelphia

Study Contact

Cora Sears, MPH
(267) 425-2122
searsc@chop.edu

Detailed 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.