Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003283
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-07-19
Brief Title:
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis The RITUXERA Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
RITUXERA
Brief Summary:
The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatmenttapering strategy with rituximab for patients with rheumatoid arthritis
The main questions it aims to answer are
What is the optimal treatmenttapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact
What is the optimal treatmenttapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy
Participants will be randomized to one of two study arms
Tapering based on disease-activity guided dose reduction experimental arm
Tapering based on interval prolongation active comparator arm
The main questions it aims to answer are
What is the optimal treatmenttapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact
What is the optimal treatmenttapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy
Participants will be randomized to one of two study arms
Tapering based on disease-activity guided dose reduction experimental arm
Tapering based on interval prolongation active comparator arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None