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Proposal 1320

Title of the Proposed Research

Utility of a measure of Lupus Low Disease Activity State in SLE

Lead Researcher

Pei Xuan Ong (Emily)

Affiliation

Monash Health

Funding Source

None

Potential Conflicts of Interest

Board memberships: AsiaPacific Rheumatology Advisory Board, UCB; Global Advisory Board, AstraZeneca.
Consultancies: Clinical trial principal investigator, AstraZeneca
Employments: None
Grants/grants pending: Research grants for lupus clinical research received from UCB Biopharma, GlaxoSmithKline, AstraZeneca, and Eli Lilly. Research grants for lupus clinical research pending from Janssen.
Patents (planned, pending or issued): None
Royalties: None
Stocks or shares (including options): None
Advisory Board / Consultancy / Presentations: UCB, GSK, Eli Lilly, Actelion
Employments: None
Grants/grants pending: Unrestricted research grants from Actelion, UCB, Pfizer, GSK.
Patents (planned, pending or issued): None
Royalties: None
Stocks or shares (including options): None

Data Sharing Agreement Date

11 March 2016

Lay Summary

Systemic Lupus Erythematosus is a multisystem autoimmune disease with an estimated incidence of 5-50 cases per 100,000 people. Despite advances in therapy, there is still significant mortality and morbidity associated with this disease. There have been no clearly defined treatment goals in SLE, hindering the development of treat to target approaches and evaluation of new therapies. Although remission is aimed for, it rarely occurs. A more achievable clinical state and treatment goal of low disease activity has been described recently and a preliminary single centre validation study has demonstrated its association with improved outcomes. This endpoint is termed Lupus Low Disease Activity State (LLDAS) (Morand et al Arthritis Rheum 2014).

The proposed study will assess the discriminant validity of the proposed LLDAS criteria in a clinical trial dataset. The objective of the research is to validate the Lupus Low Disease Activity State (LLDAS) tool as a study endpoint in SLE. The data available from the belimumab BLISS trials will be used to evaluate the LLDAS score.

The outcome of these studies will be validation of the LLDAS instrument in a clinical trial dataset, for the first time. This will allow future studies to consider incorporating LLDAS attainment as a trial endpoint, for example allowing comparison of frequency of achieving LLDAS to discriminate between treatments.

The findings will be interpreted using statistical methods and will be published / presented to the public and to peers via peer-reviewed publications, conference presentations, and where relevant the lay media.

Study Data Provided

Study GSK-HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Study GSK-HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.