Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT06653634
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2024-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Treatment for Patients With Juvenile Idiopathic Arthritis in Sustained Remission: The MOVE-JIA Trial
Sponsor:
Oslo University Hospital
Organization:
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-513017-12-00 | CTIS | None | View |