Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618937
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission a Randomized Clinical Trial Comparing Early Versus Late Drug Withdrawal Combining Imaging and Multi-Omics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Re-JIA
Brief Summary:
Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis JIA patients Nevertheless antirheumatic drugs have side effects and are costly Currently no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease CID Relapses following the withdrawal of antirheumatic drugs are common To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology
It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months
It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months
Detailed Description:
The study is designed as a multicenter prospective randomized open label superiority trial of two different treatment medication withdrawal strategies early biomarkers-guided versus conventional unguided drugs withdrawal strategy Musculoskeletal ultrasound MSUS and serum biomarkers such as the S-100 protein family allow a more accurate assessment of remission status than clinical evaluation alone Subclinical synovitis detected by MSUS at the joint level and increased level of S100 proteins have been associated with an increased risk of loss of clinically inactive disease after drug discontinuation The results of this study will provide a more rational approach to treatment withdrawal in inactive JIA patients It is expected that a risk-adapted strategy would reduce both number of disease flares and cumulative drug exposure compared with standard-of-care practice If validated these biomarkers will help to personalize immunosuppressant withdrawal a therapy paradigm shift while ensuring patient and economic benefits
Patients with inactive disease absence of sublinical synovitis at the joint level and normal S100A89 and hs-CRP leves will be randomly assigned to either an early biomarker-guided drug withdrawal protocol interventional arm or continuation of ongoing therapy at unchanged dose for an additional 6 months and then gradual tapering control arm
Patients will be evaluated at baseline then every 3 months if still on treatment and every 6 months after drug withdrawal At each timepoint the following procedures will be performed joint assessment Physicians Global Assessment of Overall Disease Activity JAMAR Uveitis assessment in ANA positive patients Hematology chemistry CRP ESR urine analysis according to drug specific schedule and Good Clinical Practice GCP Drug Adverse Events will be collected MedDRA
MSUS and serum biomarkers quantification S100A89 hs-CRP will be repeated every 3 months until month 18 in patients with subclinical synovitis and pathologic values of serum biomarkers who are randomized in the intervention arm
Blood samples for research laboratory analysis multi Omics characterization of immune cell populations and quantification of cytokines concentration and EV-miRNAs expression will be collected at baseline at drugs withdrawal and in case of disease flare
Patients with inactive disease absence of sublinical synovitis at the joint level and normal S100A89 and hs-CRP leves will be randomly assigned to either an early biomarker-guided drug withdrawal protocol interventional arm or continuation of ongoing therapy at unchanged dose for an additional 6 months and then gradual tapering control arm
Patients will be evaluated at baseline then every 3 months if still on treatment and every 6 months after drug withdrawal At each timepoint the following procedures will be performed joint assessment Physicians Global Assessment of Overall Disease Activity JAMAR Uveitis assessment in ANA positive patients Hematology chemistry CRP ESR urine analysis according to drug specific schedule and Good Clinical Practice GCP Drug Adverse Events will be collected MedDRA
MSUS and serum biomarkers quantification S100A89 hs-CRP will be repeated every 3 months until month 18 in patients with subclinical synovitis and pathologic values of serum biomarkers who are randomized in the intervention arm
Blood samples for research laboratory analysis multi Omics characterization of immune cell populations and quantification of cytokines concentration and EV-miRNAs expression will be collected at baseline at drugs withdrawal and in case of disease flare
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