Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
Juvenile Spondyloarthritis
About this trial
This is an interventional treatment trial for Juvenile Spondyloarthritis
Eligibility Criteria
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 or Spanish speaking
- 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
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Phoenix Children'sRecruiting
- Children's Hospital Los AngelesRecruiting
- Stanford UniversityRecruiting
- Children's Hospital of ColoradoRecruiting
- Nemours Children's HospitalRecruiting
- Children's National Health SystemRecruiting
- Nemours Children's HealthRecruiting
- Children's Healthcare of AtlantaRecruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- Riley Hospital for Children at IU HealthRecruiting
- University of Iowa Stead Family Children's HospitalRecruiting
- Boston Children's HospitalRecruiting
- University of Minnesota Masonic Children's HospitalRecruiting
- Children's Mercy HospitalRecruiting
- St. Louis Children's HospitalRecruiting
- Hospital for Special SurgeryRecruiting
- Cohen Children's Medical Center
- Akron Children's HospitalRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Nationwide Children's HospitalRecruiting
- Randall Children's Hospital at Legacy EmanuelRecruiting
- The Children's Hospital of PhiladelphiaRecruiting
- UPMC Children's Hospital of PittsburghRecruiting
- Vanderbilt Children's Hospital
- UT Southwestern Medical Center
- Texas Children's Hospital - Baylor College of MedicineRecruiting
- Primary Children's HospitalRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
TNFi Standard Therapy
TNFi fixed longer dosing intervals
TNFi Therapy Withdrawal
Continue fixed standard treatment (i.e., no change from current therapy)
Fixed longer dosing intervals of TNFi (i.e., increased time between doses)
Stop TNFi treatment