Last updated: 01/29/2025 07:10:06
Japan Belimumab-post Marketing cohort and Japan Lupus nationwide registry cohort studyMOONLIGHT
GSK study ID
214710
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Real world effectiveness in Japanese LN patients treated with belimumab versus standard therapy
Trial description: This study will assess the real-world effectiveness of belimumab plus standard therapy compared to standard therapy alone in participants with a history of biopsy-proven active lupus nephritis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with renal flare
Timeframe: Up to 3 years
Secondary outcomes:
Percentage of participants achieving prednisolone less than or equal to (<=) 5 milligrams average daily dose
Timeframe: Up to 3 years
Percentage of participants achieving prednisolone <=7.5 milligrams average daily dose
Timeframe: Up to 3 years
Change of prednisolone average daily dose from the index date to the end of study
Timeframe: Index date and up to 3 years
Number of participants receiving cumulative amount of prednisolone
Timeframe: Up to 3 years
Time to prednisolone <=7.5 milligrams average daily dose
Timeframe: Up to 3 years
Percentage of participants with improvement in renal items of the Safety of Estrogens in Lupus National Assessment Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) from index date
Timeframe: Up to 3 years
Percentage of participants with worsening in renal items of SELENA-SLEDAI from index date
Timeframe: Up to 3 years
Percentage of participants with a newly diagnosed biopsy proven lupus nephritis class type
Timeframe: Up to 3 years
Percentage of participants receiving (semi-)permanent dialysis or kidney transplantation
Timeframe: Up to 3 years
Change from index date in SELENA-SLEDAI score
Timeframe: Index date and up to 3 years
Percentage of participants with improvement in extra-renal, each organ items and SELENA-SLEDAI score from index date
Timeframe: Up to 3 years
Percentage of participants with worsening in extra-renal, each organ items and SELENA-SLEDAI score from index date
Timeframe: Up to 3 years
Percentage of participants with experiencing in British Isles Lupus Activity Global (BILAG) category A/B over the study period
Timeframe: Up to 3 years
Percentage of participants with experiencing in any, moderate or severe SLE-flare over the study period
Timeframe: Up to 3 years
Percentage of participants with worsening in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI) over the study period
Timeframe: Up to 3 years
Change from Baseline in complement component-3 (C3), C4 and complement total (CH50)
Timeframe: Baseline and up to 3 years
Change from Baseline in anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab)
Timeframe: Baseline and up to 3 years
Change from Baseline in serum creatinine (sCr) or estimated glomerular filtration rate (eGFR)
Timeframe: Baseline and up to 3 years
Change from Baseline in urine protein/creatinine ratio (uPCR)
Timeframe: Baseline and up to 3 years
Percentage of participants with 30 percent decline in eGFR
Timeframe: Up to 3 years
Percentage of participants with 40 percent decline in eGFR
Timeframe: Up to 3 years
Percentage of participants experiencing hospitalization caused by renal/non-renal SLE-related events and all events
Timeframe: Up to 3 years
Time to hospitalization caused by renal-/non-renal SLE related events and all events
Timeframe: Up to 3 years
Mean number of hospitalizations caused by renal-/non-renal SLE related events and all events
Timeframe: Up to 3 years
Interventions:
Not applicable
Enrollment:
3
Primary completion date:
2025-30-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
February 2022 to April 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- For both Belimumab and Comparison cohorts:
- Greater than or equal to (>=) 20 years of age, male or female
- For both Belimumab and Comparison cohorts:
- Pregnant or lactating during study period: from pre-index period.
Inclusion and exclusion criteria
Inclusion criteria:
- For both Belimumab and Comparison cohorts:
- Greater than or equal to (>=) 20 years of age, male or female
- Diagnosed SLE by using >=4 of American College of Rheumatology criteria
- Biopsy-based diagnosis of lupus nephritis class III-IV+/- V or V alone before index date: required a biopsy-proven record
- Participants who are treated with corticosteroid less than or equal to 20 milligrams per day at index date or within 30 days before index date For Belimumab cohort only:
- Participant who is recruited at PMS 207735 (NCT03370263) study site, must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Holding a prescription record of belimumab (regardless administration route) and medical record: clinical and laboratory, for 3 years from initiation of the belimumab treatment (not required continuous treatment). For Comparison cohort only:
- Participant who is registered in LUNA.
- Holding a prescription record of standard therapy and medical record: clinical and laboratory, for 3 years from index date (not required continuous treatments or not prohibited belimumab use during the follow up period).
Exclusion criteria:
- For both Belimumab and Comparison cohorts:
- Pregnant or lactating during study period: from pre-index period.
- Participants have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant before the index date.
- Participants who have been on dialysis within 364 days before the index date.
- Malignancy in active and on-going treatment with antineoplastic therapies during the study period.
- Participants who were diagnosed with biopsy-based active lupus nephritis class III or IV within 60 days before the index date.
- Participant enrolled in another study involving investigational study treatment intervention, or receives non-approved treatments such as rituximab, anifrolumab, voclosporin or other biologicals during the study period.
- Participant is deemed to be ineligible for the study for any other reason by the investigator or sub investigator. For Comparison cohort only:
- Participant who is duplicated registered in Belimumab cohort.
Trial location(s)
Showing 1 - 6 of 35 Results
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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