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

Phase 1

• Conditions: Systemic Lupus Erythematosus

• Registration Number: JPRN-jRCT1031210522
• Lead Sponsor: Kawano Yoshiaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified