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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04891640
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : April 27, 2023
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Juvenile Spondyloarthritis Other: Standard TNFi Therapy Other: TNFi fixed longer dosing intervals Other: Stop TNFi treatment Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Juvenile Spondyloarthritis (JSpA) flare [ Time Frame: 12 months ]
    JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as ≥3 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.


Secondary Outcome Measures :
  1. Pain interference (as measured by the PROMIS short form) [ Time Frame: 12 months ]
    Pain interference (as measured by the PROMIS short form) of children with spondyloarthritis in the three treatment arms. The PROMIS short form is a validated questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life.The PROMIS short form includes 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation equal to 10.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04891640


Contacts
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Contact: Cora Sears, MPH (267) 425-2122 searsc@chop.edu
Contact: Tim Brandon, MPH (267) 425-1423 brandont@chop.edu

Locations
Show Show 29 study locations
Sponsors and Collaborators
Children's Hospital of Philadelphia
Patient-Centered Outcomes Research Institute
More Information
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04891640    
Other Study ID Numbers: 21-018442
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Bone Diseases, Infectious
Infections
Bone Diseases
 Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases