Last updated: 01/03/2025 10:30:18
Evaluate the safety of Belimumab in Chinese participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2022-29-11
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)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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