Japan Belimumab-post Marketing cOhOrt and JapaN Lupus natIonwide reGistry coHorT study

JRCT ID: jRCT1031210522

Registered date:26/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 21/02/2022
• Target sample size: 200
• Study type: Observational
• Intervention(s): Not applicable

Outcome(s)

• Primary Outcome: Number of participants with renal flare [Time Frame: Up to 3 years]

Secondary Outcome

Percentage of participants achieving prednisolone less than or equal to (<=) 5 milligrams average daily dose [Time Frame: Up to 3 years]

Percentage of participants achieving prednisolone <=7.5 milligrams average daily dose [Time Frame: Up to 3 years]

Change of prednisolone average daily dose from the index date to the end of study [Time Frame: Index date and up to 3 years]

Number of participants receiving cumulative amount of prednisolone [Time Frame: Up to 3 years]

Time to prednisolone <=7.5 milligrams average daily dose [Time Frame: 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 [Time Frame: Up to 3 years]

Percentage of participants with worsening in renal items of SELENA-SLEDAI from index date [Time Frame: Up to 3 years]

Percentage of participants with a newly diagnosed biopsy proven lupus nephritis class type [Time Frame: Up to 3 years]

Percentage of participants receiving (semi-)permanent dialysis or kidney transplantation [Time Frame: Up to 3 years]

Change from index date in SELENA-SLEDAI score [Time Frame: 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 [Time Frame: Up to 3 years]

Percentage of participants with worsening in extra-renal, each organ items and SELENA-SLEDAI score from index date [Time Frame: Up to 3 years]

Percentage of participants with experiencing in British Isles Lupus Activity Global (BILAG) category A/B over the study period [Time Frame: Up to 3 years]

Percentage of participants with experiencing in any, moderate or severe SLE-flare over the study period [Time Frame: 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 [Time Frame: Up to 3 years]

Change from Baseline in complement component-3 (C3), C4 and complement total (CH50) [Time Frame: Baseline and up to 3 years]

Change from Baseline in anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) [Time Frame: Baseline and up to 3 years]

Change from Baseline in serum creatinine (sCr) or estimated glomerular filtration rate (eGFR) [Time Frame: Baseline and up to 3 years]

Change from Baseline in urine protein/creatinine ratio (uPCR) [Time Frame: Baseline and up to 3 years]

Percentage of participants with 30 percent decline in eGFR [Time Frame: Up to 3 years]

Percentage of participants with 40 percent decline in eGFR [Time Frame: Up to 3 years]

Percentage of participants experiencing hospitalization caused by renal/non-renal SLE-related events and all events [Time Frame: Up to 3 years]

Time to hospitalization caused by renal-/non-renal SLE related events and all events [Time Frame: Up to 3 years]

Mean number of hospitalizations caused by renal-/non-renal SLE related events and all events [Time Frame: Up to 3 years]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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).

Exclude 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.

Related Information

• Primary Sponsor: Kawano Yoshiaki