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

Children's Hospital of Philadelphia (CHOP)

Status: Active, not recruiting

Conditions: Juvenile Spondyloarthritis

Treatments: Other: TNFi fixed longer dosing intervals; Other: Stop TNFi treatment; Other: Standard TNFi Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04891640

21-018442

: GRT-00001036 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 3 patient groups

TNFi Standard Therapy

Active Comparator group

Description:

Continue fixed standard treatment (i.e., no change from current therapy)

Treatment:

Other: Standard TNFi Therapy

TNFi fixed longer dosing intervals

Experimental group

Description:

Fixed longer dosing intervals of TNFi (i.e., increased time between doses)

Treatment:

Other: TNFi fixed longer dosing intervals

TNFi Therapy Withdrawal

Experimental group

Description:

Stop TNFi treatment

Treatment:

Other: Stop TNFi treatment