Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654882
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-JIA
Brief Summary:
This study is an open-label randomized multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi Tumor Necrosis Factor inhibitor medications to a second TNFi active control within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi The second randomization allows identification of optimal sequential use of biologics treatment strategies
Detailed Description:
The goal of the study is to provide an evidence base for selecting sequential medications if a JIA patient fails initial bDMARD SMART-JIA is a pragmatic international open-label randomized trial comparing treatment with a second TNFi active control to each of 3 different medications IL-6i JAKi or ABA in children aged 2 to 17 years with pcJIA and inadequate response to initial TNFi Leveraging sequential multiple assignment randomized trial SMART design methodology we will implement a second randomization to assess the effectiveness of changing medication if there is inadequate response to the first study medication This approach allows identification of optimal strategies for medication sequencing based on individual characteristics and provides critical insights to inform future studies
SMART-JIA will study the efficacy of a second TNFi active control compared to each of 3 other already US Food and Drug Administration FDA-approved and European Union EU-approved non-TNFi medications currently used to treat pcJIA IL-6i JAKi and ABA TNFi IL-6i and ABA are administered by subcutaneous SQ injection weekly or every other week or every three weeks and JAKi eg tofacitinib is taken orally twice daily All study treatments have similar safety profiles and are standard of care SOC worldwide This in addition to the pragmatic and full-scale nature of the trial will ensure its completion Successful completion of this trial will substantially impact the clinical care and outcomes of children with pcJIA shifting the current trial-and-error treatment paradigm to a smart precise approach
SMART-JIA will study the efficacy of a second TNFi active control compared to each of 3 other already US Food and Drug Administration FDA-approved and European Union EU-approved non-TNFi medications currently used to treat pcJIA IL-6i JAKi and ABA TNFi IL-6i and ABA are administered by subcutaneous SQ injection weekly or every other week or every three weeks and JAKi eg tofacitinib is taken orally twice daily All study treatments have similar safety profiles and are standard of care SOC worldwide This in addition to the pragmatic and full-scale nature of the trial will ensure its completion Successful completion of this trial will substantially impact the clinical care and outcomes of children with pcJIA shifting the current trial-and-error treatment paradigm to a smart precise approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None