Skip to content

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

Juvenile Spondyloarthritis

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.

null

Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    8 to 21

Critères de participation

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

Lieu de l'étude

The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Étude parrainée par
Children's Hospital of Philadelphia
Participants recherchés
Plus d'informations
ID de l'étude: NCT04891640