Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
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|ClinicalTrials.gov Identifier: NCT04891640|
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : December 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Spondyloarthritis||Other: Standard TNFi Therapy Other: TNFi fixed longer dosing intervals Other: Stop TNFi treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Experimental: TNFi Therapy Withdrawal
Stop TNFi treatment
Other: Stop TNFi treatment
Participants randomly assigned to this arm will stop TNFi medication.
- 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.
- 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.
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
|Contact: Cora Sears, MPH||(267) firstname.lastname@example.org|
|Contact: Tim Brandon, MPH||(267) email@example.com|