Systemic Lupus Erythematosus Clinical Trial
Official title:
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study. The primary objective is to evaluate the impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making. Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized subjects who received at least 1 dose of study agent. This more severe subpopulation will have renal, neurological, haematological, or cardiovascular/respiratory organ domain involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A, B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative to the normal range at baseline.
n/a
Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03843125 -
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
|
Phase 3 | |
| Recruiting |
NCT05698173 -
Systemic Lupus Erythematosus and Accelerated Aging
|
N/A | |
| Active, not recruiting |
NCT01649765 -
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
|
Phase 2 | |
| Recruiting |
NCT05704153 -
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
|
N/A | |
| Completed |
NCT05048238 -
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
|
Phase 1 | |
| Recruiting |
NCT06056778 -
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
|
||
| Completed |
NCT04358302 -
Individual Patient Exposure and Response in Pediatric Lupus
|
N/A | |
| Completed |
NCT03802578 -
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
|
N/A | |
| Completed |
NCT02554019 -
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT04835883 -
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
|
Phase 2 | |
| Terminated |
NCT02665364 -
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00278538 -
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
| Completed |
NCT03252587 -
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
|
Phase 2 | |
| Terminated |
NCT02066311 -
Nelfinavir in Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT01892748 -
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
|
N/A | |
| Terminated |
NCT01689025 -
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
| Unknown status |
NCT01712529 -
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
|
N/A | |
| Completed |
NCT01475149 -
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
|
N/A | |
| Completed |
NCT00962832 -
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
|
Phase 2 |