NCT00732940

Brief Summary

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
2 countries

11 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 5, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

August 8, 2008

Results QC Date

April 7, 2011

Last Update Submit

August 1, 2013

Conditions

Systemic Lupus Erythematosus

Keywords

SLELupusSystemic Lupus ErythematosusAntibodiesAutoimmune DiseasesBelimumab

Outcome Measures

Primary Outcomes (9)

  • Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

    SEE ALSO ADVERSE EVENTS RESULTS SECTION

    Up to 24 weeks

  • Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24

    Baseline, 24 weeks

  • Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.

    Baseline, 24 Weeks

  • Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24

    Baseline, 24 weeks

  • Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24

    Baseline, 24 weeks

  • Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Baseline, 24 Weeks

  • Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Baseline, 24 Weeks

  • Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Baseline, 24 Weeks

  • Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Baseline, 24 Weeks

Secondary Outcomes (23)

  • Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.

    Baseline, 24 weeks

  • Absolute Change From Baseline in IgA at Week 24

    Baseline, 24 Weeks

  • Median Percent Change From Baseline in IgA at Week 24

    Baseline, 24 weeks

  • Absolute Change From Baseline in IgG at Week 24

    Baseline, 24 Weeks

  • Median Percent Change From Baseline in IgG at Week 24

    Baseline, 24 Weeks

  • +18 more secondary outcomes

Study Arms (2)

Belimumab Q2WKS

EXPERIMENTAL

Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

Drug: Belimumab 100 mg SC

Belimumab 3X/WK

EXPERIMENTAL

Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

Drug: Belimumab 100 mg SC

Interventions

Belimumab 100 mg SCDRUG

Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.

Also known as: LymphoStat-B™
Belimumab Q2WKS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Active SLE disease
  • On stable SLE treatment regimen

You may not qualify if:

  • Pregnant or nursing
  • Have received treatment with an B cell targeted therapy
  • Have received treatment with a biologic investigational agent in the past year
  • Have received intravenous (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 with the past 60 days
  • Have current drug or alcohol abuse or dependence or within the past year
  • Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35249-7201, United States

Location

Valerious Medical Group Research Center

Long Beach, California, 90806, United States

Location

Tampa Medical Group, PA

Tampa, Florida, 33614, United States

Location

Fiechtner Research, Inc.

Lansing, Michigan, 48910, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

North Shore-LIJ Health System/Rheumatology, Allergy, Immunology

Lake Success, New York, 11042, United States

Location

Rheumatology Associates

Smithtown, New York, 11787, United States

Location

STAT Research, Inc.

Dayton, Ohio, 45408, United States

Location

Oklahoma Center for Arthritis Therapy & Research

Tulsa, Oklahoma, 74104, United States

Location

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Location

Hospital Central "Igancio Morones Prieto"

San Lusi Potosi, 78240, Mexico

Location

Related Publications (1)

  • van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

    PMID: 31302695DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

March 1, 2012

Last Updated

August 7, 2013

Results First Posted

May 5, 2011

Record last verified: 2013-03

Locations

ME(1)US(10)