A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) - Tabular View

Tracking Information

First Received Date ^ICMJE

December 8, 2006

Last Updated Date

February 19, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

At Wk 52 the % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in PGA & no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy endpoint is response rate at Week 52.

Change History

Complete list of historical versions of study NCT00410384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

At Wk 76, % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in (PGA) and no new BILAG organ domain score or 2 new BILAG organ domain scores compared with baseline at the time of assessment. [ Time Frame: 76 Weeks ] [ Designated as safety issue: No ]
Percent of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score at Wk 52. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Mean change in PGA at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Mean change in SF-36 Health Survey physical component summary score (PCS) at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Percent of subjects whose average prednisone dose has been reduced by greater than or equal to 25% from baseline to less than or equal to 7.5 mg/day during Weeks 40 through 52 [ Time Frame: Weeks 40-52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

The major secondary outcome measures include
SELENA SLEDAI
Physicians Global Assessment
quality of life
prednisone usage

Descriptive Information

Brief Title ^ICMJE

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Official Title ^ICMJE

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)

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease.

Detailed Description

The purpose of this SLE trial study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Systemic Lupus Erythematosus

Intervention ^ICMJE

Drug: belimumab
Drug: Placebo

Study Arms / Comparison Groups

Experimental: 1mg/kg
Experimental: 10mg/kg
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

810

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

Clinical diagnosis of SLE by ACR criteria.
Active SLE disease.
On stable SLE treatment regimen.

Key Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Canada, Costa Rica, Czech Republic, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00410384

Responsible Party

William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.

Study ID Numbers ^ICMJE

HGS1006-C1056, BLISS-76

Study Sponsor ^ICMJE

Human Genome Sciences

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

Information Provided By

Human Genome Sciences

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP