Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653634
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Optimizing Treatment for Patients with Juvenile Idiopathic Arthritis in Sustained Remission the MOVE-JIA Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Treatment for Children and Adolescents with Juvenile Idiopathic Arthritis in Sustained Remission a Comparison of Three Treatment Strategies the MOVE-JIA Trial
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:
MOVE-JIA
Brief Summary:
The goal of this clinical trial is to compare three different maintenance and step-down treatment strategies in children and adolescents with juvenile idiopathic arthritis in sustained remission The main questions it aims to answer are
Is the proportion of study participants with a disease flare different between each of the two drug withdrawal arms and the stable treatment arm during 12 months
Does the proportion of study participants with a disease flare differ between the two drug withdrawal arms during 12 months
How long time does it take before a disease flare occurs and how long does it take before disease remission is reestablished for participants in the different treatment arms
Participants will be randomized to either A continued stable treatment with methotrexate and tumor-necrosis alpha inhibitor TNFi B gradual withdrawal of methotrexate while continued stable dose TNFi or C gradual withdrawal of TNFi
Participants will be examined every 4 month and with extra visits if they experience increased symptoms or suspect a disease flare If a flare occurs the medications received at study inclusion will be restarted
Is the proportion of study participants with a disease flare different between each of the two drug withdrawal arms and the stable treatment arm during 12 months
Does the proportion of study participants with a disease flare differ between the two drug withdrawal arms during 12 months
How long time does it take before a disease flare occurs and how long does it take before disease remission is reestablished for participants in the different treatment arms
Participants will be randomized to either A continued stable treatment with methotrexate and tumor-necrosis alpha inhibitor TNFi B gradual withdrawal of methotrexate while continued stable dose TNFi or C gradual withdrawal of TNFi
Participants will be examined every 4 month and with extra visits if they experience increased symptoms or suspect a disease flare If a flare occurs the medications received at study inclusion will be restarted
Detailed Description:
None
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