A Model About the Response of Belimumab in SLE

NCT04893161 | Unknown Phase 4

• 1 other identifier: XJTU1AF2020LSK-278
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Establishment of predictive model to assess the SRI response rate.

  An SRI response is defined as a ≥ 4-point reduction in SELENA-SLEDAI score, no new BILAG A organ domain score and no more than 1 new BILAG B score, and no worsening (increase \< 0.3) in PGA score versus baseline.

  at week 48

Secondary Outcomes (2)

• The SRI-4 response rate

  at week 48

• The rate of adverse events

  week 0 to week 48

Study Arms (1)

belimumab

OTHER

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. The patients who had SRI-4 response at week 48 were divided into response group and the patients without SRI-4 response at week 48 were divided into no response group.

Drug: Belimumab

Interventions

Belimumab DRUG

All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.

Also known as: The standard care

belimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfillment of the 1997 American College of Rheumatology (ACR) revised criteria for SLE;
• Aged more than 18 years;
• 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.

You may not qualify if:

• Have a history of malignant neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years;
• Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk;
• Have a history of a primary immunodeficiency;
• Have a significant IgG deficiency (IgG level \< 400 mg/dL);
• Have an IgA deficiency (IgA level \< 10 mg/dL)
• Have cyclophosphamide or rituximab treatment.
• Infection history:
• Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) Hospitalization for treatment of infection within 60 days of Day 0; Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Day 0.
• Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0;
• Have a historically positive HIV test or test positive at screening for HIV;
• Hepatitis status:
• Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:
• Patients positive for HBsAg or HBcAb are excluded Positive test for Hepatitis C antibody
• Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies;
• Have any other clinically significant abnormal laboratory value in the opinion of the investigator;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (1)

• Wang J, Ju B, Zhu L, Li H, Luo J, Zhang J, Hu N, Mo L, Wang Y, Pan Y, Huang J, Lv X, Pu D, Hao Z, He L, Li Y. The rapid inhibition of B-cell activation markers by belimumab was associated with disease control in systemic lupus erythematosus patients. Front Pharmacol. 2023 Feb 16;14:1080730. doi: 10.3389/fphar.2023.1080730. eCollection 2023.

  PMID: 36873989 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lan He, Dr.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Jing Wang, Dr.

CONTACT

0086-18092691661; kidip@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 19, 2021
• Study Start: June 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share