NCT02769195

Utility of a Measure of Lupus Low Disease Activity State (LLDAS) in SLE

Utility of a Measure of Lupus Low Disease Activity State (LLDAS) in SLE: Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Trials

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,684 (actual)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a secondary, pooled analysis of two completed phase 3 clinical trials: (i) GSK-HGS1006-C1056 (BLISS-76): 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); and, (ii) GSK-HGS1006-C1057 (BLISS-52): 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) The study will assess the discriminant validity of a proposed measure of low disease activity (the Lupus Low Disease Activity State, LLDAS) in patients with SLE.

Detailed description

Systemic Lupus Erythematosus (SLE) 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). 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.

Conditions

• Systemic Lupus Erythematosus

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-05-11
• Last updated: 2019-08-21