NCT02769195

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

April 12, 2016

Last Update Submit

August 19, 2019

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Number of participants who attain the Lupus Low Disease Activity State (LLDAS)

    A composite end-point involving SLEDAI-2K ≤4 with no reported renal, central nervous system, cardiopulmonary, vasculitis or gastrointestinal activity and no reported fever, hemolytic anemia or new disease activity since last assessment), SELENA-SLEDAI Physician Global Assessment ≤1, a current prednisolone dose of ≤7.5 mg daily and tolerance of maintenance doses of immunosuppressive drugs and approved biologic agents.

    52 weeks

Secondary Outcomes (1)

  • Number of patients achieving a SLE Responder Index (SRI) Response

    52 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants of the BLISS-76 and BLISS-52 Phase 3 clinical trials. Refer to ClinicalTrials.gov records NCT00410384 and NCT00424476 for further information about these studies.

You may qualify if:

  • Clinical diagnosis of SLE by ACR criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • On stable SLE treatment regimen.

You may not qualify if:

  • Pregnant or nursing
  • Have received treatment with any B cell targeted therapy.
  • Have received treatment with a biological investigational agent in the past year.
  • Have received IV cyclophosphamide within 180 days of Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have required management of acute or chronic infections within the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Franklyn K, Lau CS, Navarra SV, Louthrenoo W, Lateef A, Hamijoyo L, Wahono CS, Chen SL, Jin O, Morton S, Hoi A, Huq M, Nikpour M, Morand EF; Asia-Pacific Lupus Collaboration. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis. 2016 Sep;75(9):1615-21. doi: 10.1136/annrheumdis-2015-207726. Epub 2015 Oct 12.

    PMID: 26458737BACKGROUND

  • Oon S, Huq M, Golder V, Ong PX, Morand EF, Nikpour M. Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus. Ann Rheum Dis. 2019 May;78(5):629-633. doi: 10.1136/annrheumdis-2018-214427. Epub 2019 Jan 24.

    PMID: 30679152BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 12, 2016

First Posted

May 11, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

This study is a secondary analysis of two existing clinical trial datasets. Anyone who wants to use the data should contact the primary study sponsor (GSK) via their data sharing website: https://clinicalstudydatarequest.com/