At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 67 enrolled
Drug / intervention
Belimumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)
In Brief
A Phase 4 clinical trial evaluating Belimumab and Standard therapy for Systemic Lupus Erythematosus. Completed, enrolled 67 participants across 9 sites.
Detailed Summary
This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartOct 2021
Primary CompletionMay 2024
Study CompletionAug 2024
TodayJul 2026
First PostedJun 1, 2021
Enrollment StartOct 21, 2021
Primary CompletionMay 23, 2024
Study CompletionAug 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.1 years ago
Interventions
Belimumabdrug
Belimumab will be administered.
Standard therapydrug
Standard therapy will be continued.