Lupus & antiphospholipid syndrome
Real-world effectiveness of belimumab in patients with lupus in China: RELIABLE observational cohort study protocol
Study context
- Population
- Adults with SLE newly initiating belimumab with ≥1 measure of all five Lupus Low Disease Activity State (LLDAS) components in the 3 months before initiation, ≈15 centres in China
- Primary endpoint
- Proportion of patients achieving LLDAS
- Follow-up
- 12 and 24 months post-index
Methodological detailsambidirectional, descriptive, multicentre (≈15 centres), Retrospective and/or prospective enrolment; retrospective follow-up ≤6 months; maximum 24-month follow-up, Key secondary objective: proportion achieving LLDAS and each component at 3, 6, 9 and 18 months post-index, Descriptive analysis; statistical estimand applied to account for intercurrent events
- Ambidirectional
- Descriptive
- Multicentre (≈15 centres)
- Retrospective and/or prospective enrolment; retrospective follow-up ≤6 months; maximum 24-month follow-up
- Key secondary objective: proportion achieving LLDAS and each component at 3, 6, 9 and 18 months post-index
- Descriptive analysis; statistical estimand applied to account for intercurrent events
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Real-world effectiveness of belimumab in patients with lupus in China: RELIABLE observational cohort study protocol. Lupus Sci Med. Published 11 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →