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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511911', 'term': 'belimumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2021-05-16', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of predictive model to assess the SRI response rate.', 'timeFrame': 'at week 48', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The SRI-4 response rate', 'timeFrame': 'at week 48', 'description': '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.'}, {'measure': 'The rate of adverse events', 'timeFrame': 'week 0 to week 48', 'description': 'all adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '36873989', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.', 'detailedDescription': 'Preamble:\n\nBelimumab 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).\n\nIn 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.\n\nObjectives:\n\nPrimary objective: in the patients with SLE, an early predictive model of the response of belimumab treatment will be estimated.\n\nSecondary objectives:\n\nIn subjects with SLE receiving belimumab treatment, to assess the effect of belimumab on:\n\nThe 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.\n\nThe mechanism of BAFF inhibition on the survival and selection of SLE non-switched memory B cells.\n\nThe recovering of immune checkpoint in non-switched memory B cells from the view of BCR mutation.\n\nThe rates of adverse events.\n\nOverview of study design:\n\nThis 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.\n\nStudy population:\n\nMen 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fulfillment of the 1997 American College of Rheumatology (ACR) revised criteria for SLE;\n* Aged more than 18 years;\n* 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.\n\nExclusion Criteria:\n\n* 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;\n* 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;\n* Have a history of a primary immunodeficiency;\n* Have a significant IgG deficiency (IgG level \\< 400 mg/dL);\n* Have an IgA deficiency (IgA level \\< 10 mg/dL)\n* Have cyclophosphamide or rituximab treatment.\n* Infection history:\n\nCurrently 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.\n\n* 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;\n* Have a historically positive HIV test or test positive at screening for HIV;\n* Hepatitis status:\n\nSerologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:\n\nPatients positive for HBsAg or HBcAb are excluded Positive test for Hepatitis C antibody\n\n* Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies;\n* Have any other clinically significant abnormal laboratory value in the opinion of the investigator;\n* Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT04893161', 'acronym': 'MRBS', 'briefTitle': 'A Model About the Response of Belimumab in SLE', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'XJTU1AF2020LSK-278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'belimumab', 'description': '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.', 'interventionNames': ['Drug: Belimumab']}], 'interventions': [{'name': 'Belimumab', 'type': 'DRUG', 'otherNames': ['The standard care'], 'description': '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.', 'armGroupLabels': ['belimumab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jing Wang, Dr.', 'role': 'CONTACT', 'email': 'kidip@163.com', 'phone': '0086-18092691661'}], 'overallOfficials': [{'name': 'Lan He, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}