Last updated: 01/03/2025 10:30:18

Evaluate the safety of Belimumab in Chinese participants

GSK study ID
213210
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Observational Study to Evaluate the Safety of Belimumab in Chinese patients
Trial description: Belimumab is a human immunoglobulin-G1 lambda (λ) monoclonal antibody that inhibits beta (B)-lymphocyte stimulator protein, that promotes the survival of B lymphocytes. This study is initiated as real-world, observational study to proactively collect and evaluate safety of belimumab in Chinese participants. The safety information of all adverse events (AEs) and serious adverse events (SAEs) occurring in the observation period will be collected and analyzed. The total duration of the study will be 24 weeks with 4 visits. The investigator will enroll all eligible participants during the predefined surveillance period and all enrolled participants will be followed up by the treating investigator according to the clinical need. At least 3000 participants from clinical visits for intensive drug monitoring will be included. An Electronic Data Capture (EDC) system will be used to capture data in case report form in this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with adverse events (AEs)

Timeframe: Up to Week 24

Number of participants with serious adverse events (SAEs)

Timeframe: Up to Week 24

Number of participants with adverse drug reactions (ADRs) through 24 weeks

Timeframe: Up to Week 24

Number of participants with adverse events of special interest (AESIs)

Timeframe: Up to Week 24

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Belimumab
    • Enrollment:
    0
    Primary completion date:
    2022-29-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Zhuoli Zhang, Zhizhong Ye, Shanzhi He, Lin Tang, Chuanmei Xie, Songlou Yin, Shuhong Chi, Jing Yang, Qinghong Yu, Min Yang, Xuefeng Zhao, Yifan He, Jingwen Hu, Weibo Wang, Annie Tung. Belimumab safety in adult and paediatric Chinese patients with systemic lupus erythematosus: A Phase 4, multicentre, observational study. Lupus. 2024-Nov-08;: 9612033241299175. doi:10.1177/09612033241299175 http://dx.doi.org/10.1177/09612033241299175 PMID: 39517123 DOI: 10.1177/09612033241299175
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    May 2021 to November 2022
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    5 Years - NA
    Accepts healthy volunteers
    No
    • Participants who have been prescribed belimumab by investigators for their medical condition
    • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). Participants who will provide reliable contact details for follow-up visit/early discontinuation
    • Participants participating in clinical trials or who start belimumab as part of clinical trials at the time of informed consent process
    • Participants who are not considered suitable to be included by any reason judged by the investigator
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants who have been prescribed belimumab by investigators for their medical condition
    • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). Participants who will provide reliable contact details for follow-up visit/early discontinuation
    Exclusion criteria:
    • Participants participating in clinical trials or who start belimumab as part of clinical trials at the time of informed consent process
    • Participants who are not considered suitable to be included by any reason judged by the investigator

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Shenzhen, China, 518034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yinchuan, China, 750004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chongqing, China
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chongqing, China, 400010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gaozhou, China
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guangzhou, China, 510000
    Status
    Study Complete
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    Showing 1 - 6 of 19 Results

    Study documents

    Study report synopsis
    Available language(s): English
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    Protocol
    Available language(s): English
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    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2022-29-11
    Actual study completion date
    2022-29-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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