Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714930
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-01-10
Brief Title:
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus A Multicenter Two-armed Cluster-randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Lupus-Best
Brief Summary:
Multicenter national two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target T2T strategy in in systemic lupus erythematosus SLE 14 centers will be randomized 11 to T2T or standard of care Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes
Detailed Description:
This is a multicenter national two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target T2T strategy in in systemic lupus erythematosus SLE on damage progression and health related quality of life HRQoL The study centers will be assigned 11 to standard of care SoC or remission defined as the absence of clinical disease activity clinical SLEDAI 0 AND prednisolone 5mgday AND physician global assessment PGA 05 on a VAS 0-3 Patient with SLE 18 years of age who are not in remission will be eligible
Per arm 303 patients will be included Intervention centers receive a standardized training on T2T and shared decision making SDM In the intervention centers patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments at least 4 visits or until remission is reached and maintained Patients in remission are reassessed every 12 weeks In case of flare they can re-enter tight control based on SDM In the SoC arm patients receive 3- to 6-monthly controls and treatment adjustments according to the physicians discretion Study duration is 120 weeks using damage accrual and HRQoL as major outcomes
Per arm 303 patients will be included Intervention centers receive a standardized training on T2T and shared decision making SDM In the intervention centers patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments at least 4 visits or until remission is reached and maintained Patients in remission are reassessed every 12 weeks In case of flare they can re-enter tight control based on SDM In the SoC arm patients receive 3- to 6-monthly controls and treatment adjustments according to the physicians discretion Study duration is 120 weeks using damage accrual and HRQoL as major outcomes
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?:
None
Is an FDA AA801 Violation?:
None