Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-01 @ 1:51 PM
Study NCT ID:
NCT04893161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2021-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Model About the Response of Belimumab in SLE
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
MRBS
Brief Summary:
A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.
Detailed Description:
Preamble:
Belimumab is an inhibitor of B cell activating factor (BAFF) that has been developed as an agent for the treatment of patients with systemic lupus erythematosus (SLE).
In July 2019, belimumab was approved for marketing in China. The belimumab treatment has been proved to reduce the level of autoantibodies and control disease activity in the patients with SLE. The response rate of SLE Responder Index-4 (SRI-4) is approximately 50% in the BLISS-52 and BLISS-76 phase III clinical trials. The goal of this study is to establish a predictive model (including immune marker, inflammatory biomarker and clinical factor) to early estimate the response of belimumab treatment.
Objectives:
Primary objective: in the patients with SLE, an early predictive model of the response of belimumab treatment will be estimated.
Secondary objectives:
In subjects with SLE receiving belimumab treatment, to assess the effect of belimumab on:
The clinical improvement; The serological variables improvemen. The inflammatory biomarkers improvemen. The quality of life. The dosage of prednisone. The kinetics of B cell phenotype. The function of non-switched memory B cells. The association between the immune, inflammatory and clinical markers and the response of belimumab.
The mechanism of BAFF inhibition on the survival and selection of SLE non-switched memory B cells.
The recovering of immune checkpoint in non-switched memory B cells from the view of BCR mutation.
The rates of adverse events.
Overview of study design:
This is a prospective, single-center cohort study to estimate a predictive model of the response of belimumab. All patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. All patients are evaluated at week 0, 2, 4, 8, 12, 24, 36, and 48. The immune markers, inflammatory biomarkers, clinical markers and safety data are assessed following belimumab treatment.
Study population:
Men or women with SLE who have active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria \> 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria \> 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
Belimumab is an inhibitor of B cell activating factor (BAFF) that has been developed as an agent for the treatment of patients with systemic lupus erythematosus (SLE).
In July 2019, belimumab was approved for marketing in China. The belimumab treatment has been proved to reduce the level of autoantibodies and control disease activity in the patients with SLE. The response rate of SLE Responder Index-4 (SRI-4) is approximately 50% in the BLISS-52 and BLISS-76 phase III clinical trials. The goal of this study is to establish a predictive model (including immune marker, inflammatory biomarker and clinical factor) to early estimate the response of belimumab treatment.
Objectives:
Primary objective: in the patients with SLE, an early predictive model of the response of belimumab treatment will be estimated.
Secondary objectives:
In subjects with SLE receiving belimumab treatment, to assess the effect of belimumab on:
The clinical improvement; The serological variables improvemen. The inflammatory biomarkers improvemen. The quality of life. The dosage of prednisone. The kinetics of B cell phenotype. The function of non-switched memory B cells. The association between the immune, inflammatory and clinical markers and the response of belimumab.
The mechanism of BAFF inhibition on the survival and selection of SLE non-switched memory B cells.
The recovering of immune checkpoint in non-switched memory B cells from the view of BCR mutation.
The rates of adverse events.
Overview of study design:
This is a prospective, single-center cohort study to estimate a predictive model of the response of belimumab. All patients with SLE receive belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48. All patients are evaluated at week 0, 2, 4, 8, 12, 24, 36, and 48. The immune markers, inflammatory biomarkers, clinical markers and safety data are assessed following belimumab treatment.
Study population:
Men or women with SLE who have active (according to SLEDAI-2K) and refractory SLE manifestations. SLE manifestations are defined as refractory in case of drug intolerance, unresponsiveness, or disease relapse in patients treated with corticosteroids, antimalarials, and/or immunosuppressants. Patients with renal disease were considered as refractory when they had a persistence of 24 hours proteinuria \> 1 g after at least 1 year from the start of the initial therapy or when they experienced a renal flare (24 hours proteinuria \> 1 g in case of previous complete response or doubling 24 hours proteinuria in other cases) during the subsequent therapy.
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?: