A Model About the Response of Belimumab in SLE

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Belimumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study.