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CompletedNCT00410384BLISS-76Updated Feb 1, 2017Results posted

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

A Phase 3 interventional study of Placebo and Belimumab 1 mg/kg in Systemic Lupus Erythematosus, sponsored by Human Genome Sciences Inc.. Completed at 146 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Human Genome Sciences Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
819
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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, autoantibody-positive systemic lupus erythematosus (SLE) disease.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Antibodies
  • Autoimmune Diseases
  • Systemic Lupus Erythematosus
  • SLE
  • Belimumab
  • Lupus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 819 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Human Genome Sciences Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by ACR criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
819 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Experimental
    Belimumab 1 mg/kg

    Belimumab 1 mg/kg

    Drug: Belimumab 1 mg/kg

  • Experimental
    Belimumab 10 mg/kg

    Belimumab 10 mg/kg

    Drug: Belimumab 10 mg/kg

Interventions

  • DrugPlacebo

    Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

  • DrugBelimumab 1 mg/kg

    Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

    Also known as: LymphoStat-B™, belimumab

  • DrugBelimumab 10 mg/kg

    Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

    Also known as: LymphoStat-B™, belimumab

06

What researchers measure

Primary outcomes

  1. SLE Responder Index (SRI) Response Rate at Week 52

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

    Time frame: Baseline, 52 Weeks

Secondary outcomes

  1. SRI Response Rate at Week 76

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

    Time frame: Baseline, 76 Weeks

  2. Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.

    Time frame: Baseline, 52 Weeks

  3. Mean Change in Physician's Global Assessment (PGA) at Week 24.

    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

    Time frame: Baseline, 24 Weeks

  4. Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.

    The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

    Time frame: Baseline, 24 Weeks

  5. Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52

    Time frame: Baseline, Weeks 40-52

Other outcomes

  1. Adverse Event (AE) Overview

    SEE ALSO ADVERSE EVENT RESULTS SECTION

    Time frame: Up to 80 Weeks

07

Results

Posted May 5, 2011

Participant flow

Participant flow — Overall Study
MilestonePlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Started275271273
Completed186199191
Not completed897282
Withdrew: Withdrawal by subject281720
Withdrew: Adverse event231823
Withdrew: Lack of efficacy201217
Withdrew: Lack of compliance222
Withdrew: Lost to follow-up466
Withdrew: Protocol violation666
Withdrew: Physician decision334
Withdrew: Other384

Outcome measures

PrimarySLE Responder Index (SRI) Response Rate at Week 52

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Time frame:
Baseline, 52 Weeks
Reported as:
Number · Percentage of participants
SLE Responder Index (SRI) Response Rate at Week 52
Percentage of participantsPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
SLE Responder Index (SRI) Response Rate at Week 5233.540.643.2
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.0167 (For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.) · Odds ratio (or): 1.54 · 95% CI 1.08 to 2.19Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)
  • Placebo vs Belimumab 1 mg/kg · Regression, Logistic · p = 0.0889 (After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)) · Odds ratio (or): 1.36 · 95% CI 0.95 to 1.94Adjusted for baseline stratification factors.
SecondarySRI Response Rate at Week 76

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Time frame:
Baseline, 76 Weeks
Reported as:
Number · Percentage of participants
SRI Response Rate at Week 76
Percentage of participantsPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
SRI Response Rate at Week 7632.439.138.5
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.1323 · Odds ratio (or): 1.31 · 95% CI 0.92 to 1.87Analysis was adjusted for baseline stratification factors.
  • Placebo vs Belimumab 1 mg/kg · Regression, Logistic · p = 0.1050 · Odds ratio (or): 1.34 · 95% CI 0.94 to 1.91Analysis was adjusted for baseline stratification factors.
SecondaryPercent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Time frame:
Baseline, 52 Weeks
Reported as:
Number · Percentage of participants
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Percentage of participantsPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.35.342.846.5
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.0063 · Odds ratio (or): 1.63 · 95% CI 1.15 to 2.32Adjusted for baseline stratification factors.
  • Placebo vs Belimumab 1 mg/kg · Regression, Logistic · p = 0.0740 · Odds ratio (or): 1.38 · 95% CI 0.97 to 1.96Adjusted for baseline stratification factors.
SecondaryMean Change in Physician's Global Assessment (PGA) at Week 24.

The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

Time frame:
Baseline, 24 Weeks
Reported as:
Mean · Scores on a 3-point scale
Mean Change in Physician's Global Assessment (PGA) at Week 24.
Scores on a 3-point scalePlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Mean Change in Physician's Global Assessment (PGA) at Week 24.-0.49 ± 0.04-0.47 ± 0.04-0.44 ± 0.03
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · ANCOVA · p = 0.7962Adjusted for baseline PGA and baseline stratification factors.
  • Placebo vs Belimumab 1 mg/kg · ANCOVA · p = 0.9703Adjusted for baseline PGA and baseline stratification factors.
SecondaryMean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.

The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

Time frame:
Baseline, 24 Weeks
Reported as:
Mean · Scores on a scale
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.
Scores on a scalePlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.3.35 ± 0.513.78 ± 0.463.21 ± 0.43
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · ANCOVA · p = 0.6583Analysis adjusted for baseline PCS and baseline stratification factors.
  • Placebo vs Belimumab 1 mg/kg · ANCOVA · p = 0.3762Analysis adjusted for baseline PCS and baseline stratification factors.
SecondaryPercent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
Time frame:
Baseline, Weeks 40-52
Reported as:
Number · Percentage of participants
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52
Percentage of participantsPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 5212.7 (0.78 to —)19.217.5
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.4253 · Odds ratio (or): 1.34 · 95% CI 0.65 to 2.74Analysis was adjusted for baseline prednisone dose and baseline stratification factors.
  • Placebo vs Belimumab 1 mg/kg · Regression, Logistic · p = 0.2081 · Odds ratio (or): 1.56 · 95% CI 0.78 to 3.13Analysis was adjusted for baseline prednisone dose and baseline stratification factors.
Other pre-specifiedAdverse Event (AE) Overview

SEE ALSO ADVERSE EVENT RESULTS SECTION

Time frame:
Up to 80 Weeks
Reported as:
Number · Percentage of participants
Adverse Event (AE) Overview
Percentage of participantsPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Percent of patients with at least 1 AE92.093.492.7
Percent of patients with at least 1 Serious AE19.623.222.3
Percent of patients with an AE resulting in death0.00.70.4

Adverse events

Collected over Up to 80 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—54/275 (19.6%)213/275 (77.5%)
Belimumab 1 mg/kg—63/271 (23.2%)217/271 (80.1%)
Belimumab 10 mg/kg—61/273 (22.3%)219/273 (80.2%)
Most frequent serious events
Showing 10 of 212
Most frequent serious events
EventPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
PneumoniaInfections and infestations4/2753/2715/273
Lupus nephritisRenal and urinary disorders5/2752/2713/273
AnaemiaBlood and lymphatic system disorders2/2752/2714/273
PyrexiaGeneral disorders2/2751/2714/273
Non-cardiac chest painGeneral disorders4/2750/2710/273
Abdominal painGastrointestinal disorders1/2753/2710/273
Urinary tract infectionInfections and infestations3/2753/2713/273
Infusion related reactionGeneral disorders0/2751/2713/273
BronchitisInfections and infestations1/2750/2713/273
PleurisyRespiratory, thoracic and mediastinal disorders0/2750/2713/273
Most frequent other events
Showing 10 of 34
Most frequent other events
EventPlaceboBelimumab 1 mg/kgBelimumab 10 mg/kg
Upper respiratory tract infectionInfections and infestations58/27553/27154/273
HeadacheNervous system disorders38/27556/27143/273
Urinary tract infectionInfections and infestations41/27550/27141/273
NauseaGastrointestinal disorders27/27542/27145/273
NasopharyngitisInfections and infestations24/27529/27143/273
ArthralgiaMusculoskeletal and connective tissue disorders42/27542/27141/273
DiarrhoeaGastrointestinal disorders28/27534/27133/273
SinusitisInfections and infestations28/27521/27131/273
BronchitisInfections and infestations20/27519/27130/273
PyrexiaGeneral disorders19/27522/27127/273

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboBelimumab 1 mg/kgBelimumab 10 mg/kgTotal
Mean40.0 ± 11.940.0 ± 11.440.5 ± 11.140.2 ± 11.5
Age, Customized
Age, Customized(participants)PlaceboBelimumab 1 mg/kgBelimumab 10 mg/kgTotal
≤ 45 years189184178551
Between 45 and 65 years778392252
≥ 65 years94316
Gender
Gender(Participants)PlaceboBelimumab 1 mg/kgBelimumab 10 mg/kgTotal
Female252253259764
Male23181455
Region of Enrollment
Region of Enrollment(participants)PlaceboBelimumab 1 mg/kgBelimumab 10 mg/kgTotal
North America145155136436
Europe10090105295
Central America30263288
08

Study locations

146 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
  • Arizona Arthritis and Rheumatology Research, PPLC
    Paradise Valley, Arizona 85253, United States
  • The University of Arizona Arthritis Center
    Tucson, Arizona 85724, United States
  • Talbert Medical Group
    Huntington Beach, California 92646, United States
  • Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
    Long Beach, California 90806, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Wallace Rheumatic Study Center
    Los Angeles, California 90048, United States
  • UCLA Rheumatology
    Los Angeles, California 90095, United States
  • Arthritis Care Center, Inc.
    San Jose, California 95126, United States
  • Inland Rheumatic Disease Specialties
    Upland, California 91786, United States
  • Arthritis Associates of Colorado Springs
    Colorado Springs, Colorado 80910, United States
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Arthritis and Rheumatic Disease Specialties
    Aventura, Florida 33180, United States
  • University of Miami-Division of Rheumatology and Immunology
    Miami, Florida 03136, United States
  • Rheumatology Associates of Central Florida
    Orlando, Florida 32806, United States
  • Southwest Florida Clinical Research Center
    Tampa, Florida 33609, United States
  • Tampa Medical Group, P.A.
    Tampa, Florida 33614, United States
  • Emory University
    Atlanta, Georgia 30303, United States
  • Selah Medical Clinical Research Unit
    Boise, Idaho 83704, United States
  • Rheumatology Associates, SC
    Chicago, Illinois 60612, United States
  • University of Chicago Hospitals
    Chicago, Illinois 60637, United States
  • Medical Specialists Clinical Research
    Munster, Indiana 46321, United States
  • Kansas University Medical Center
    Kansas City, Kansas 66160, United States
  • Kentuckiana Center for Better Bone and Joint Health
    Louisville, Kentucky 40202, United States
  • Ochsner Clinic Foundation
    Baton Rouge, Louisiana 70809, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Osteoporosis and Clinical Trials Center
    Cumberland, Maryland 21502, United States
  • Osteoporosis & Clinical Trials Center
    Hagerstown, Maryland 21740, United States
  • Tufts - New England Medical Center
    Boston, Massachusetts 02111, United States
  • University of Michigan Medical Center - Regents of University of Michigan
    Ann Arbor, Michigan 48109-0358, United States
  • Fiechtner Research, Inc.
    Lansing, Michigan 48910, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • Stafford Medical Associates, PA
    Dover, New Hampshire 03820, United States
  • Montefiore Medical Center
    Bronx, New York 10461, United States
  • SUNY-Downstate Medical Center
    Brooklyn, New York 11203, United States
  • North Shore-LIJ Health System/Rheumatology and Allergy Clinic
    Lake Success, New York 11042, United States
  • Feinstein Institute
    Manhasset, New York 11030, United States
  • Hopital for Joint Diseases
    New York, New York 10003, United States
  • Hospital for Special Surgery
    New York, New York 10021, United States
  • AAIR Research Center
    Rochester, New York 14618, United States
  • Rheumatology Associates
    Smithtown, New York 11787, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599-7600, United States
  • Physicians East, PA
    Greenville, North Carolina 27834, United States
  • Wake Forest University Health Services
    Winston-Salem, North Carolina 27157, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • STAT Research, Inc.
    Dayton, Ohio 45408, United States
  • Oklahoma Medical Research Center
    Oklahoma City, Oklahoma 74104, United States
  • Oklahoma Center For Arthritis Therapy & Research
    Tulsa, Oklahoma 74104, United States
  • East Penn Rheumatology Associates
    Bethlehem, Pennsylvania 18015, United States
  • Altoona Center for Clinical Research
    Duncanville, Pennsylvania 16635, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Low Country Rheumatology, PA/Low Country Research Center
    Charleston, South Carolina 29406, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Palmetto Clinical Trial at Piedmont Arthritis Clinic
    Greenville, South Carolina 29601, United States
  • Walter Chase
    Austin, Texas 78705, United States
  • University of Texas - Southwestern Medical Center
    Dallas, Texas 75390-8884, United States
  • Texas Tech University Health Sciences Center
    El Paso, Texas 79905, United States
  • The Rheumatic Disease Clinical Research Center
    Houston, Texas 77004, United States
  • Accurate Clinical Research
    Houston, Texas 77034, United States
  • Houston Institute for Clinical Research
    Houston, Texas 77074, United States
  • Arthritis Center of South Texas
    San Antonio, Texas 78232, United States
  • Texas Research Center
    Sugar Land, Texas 77479, United States
  • Rheumatology Clinic
    Salt Lake City, Utah 84124, United States
  • Arthritis Clinic of Northern Virginia, P.C.
    Arlington, Virginia 22205, United States
  • The Seattle Arthritis Clinic
    Seattle, Washington 98133, United States
  • Arthritis Northwest, PLLC
    Spokane, Washington 99204, United States
  • Gundersen Clinic, Ltd.
    Onalaska, Wisconsin 54650, United States
  • Universitatsklinik fur innere Medizin
    Graz, 8036, Austria
  • Rheumazentrum Favoriten
    Vienna, 1100, Austria
  • Cliniques Universitaires
    Brussels, 1200, Belgium
  • University Hospital
    Leuven, 3000, Belgium
  • CHU Sart Tilman
    Liege, 4000, Belgium
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
  • Centre for Prognosis Studies in Rheaumatic Diseases
    Toronto, Ontario M5T2S8, Canada
  • McGill University Health Centre, Montreal General Hospital
    Montreal, H3G 1A4, Canada
  • Hospital Clinica Biblica
    San Jose, Costa Rica
  • University Hospital Brno
    Brno, 62500, Czech Republic
  • University Hospital Hradec Kralove
    Hradec Kralove, 50005, Czech Republic
  • University Hospital Olomouc
    Olomouc, 77520, Czech Republic
  • Institute of Rheumatology
    Prague, 12850, Czech Republic
  • CHU Hospital de Bicetre
    Le Kremlin Bicetre, 94270, France
  • Hospital Huriez
    Lille Cedex, 59037, France
  • Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
    Stasbourg, 67091, France
  • Hospital FOCH
    Suresnes Cedex, 92151, France
  • Centre Hospitalier Universitarie (CHU) - PURPAA
    Toulouse, 31059, France
  • Kerckhoff-Klink Bad Nauheim
    Bad Nauheim, 61231, Germany
  • Schlossparkklinik
    Berlin, 10589, Germany
  • Charite
    Berlin, 13353, Germany
  • Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
    Dusseldorf, 40225, Germany
  • FA Universitat Erlangen Nurnberg
    Erlangen, 91054, Germany
  • Universitatsklinikum Frankfurt
    Frankfurt, 60590, Germany
  • Medizinische Universitatsklinik
    Freiburg, 79106, Germany
  • Medizinische Hochschule Hannover
    Hannover, 30625, Germany
  • Friedrich Schiller Universitat
    Jena, 07740, Germany
  • Universitatsklinik Schleswig-Holstein, Campus Kiel
    Kiel, 24105, Germany
  • Universitatsklinikum Leipzig
    Leipzig, 04103, Germany
  • Universitatsklinik Mainz
    Mainz, 55131, Germany
  • Universitatsklinikum Tubingen
    Tubingen, 72076, Germany
  • Soroka University Medical Center
    Beer-Sheva, 84101, Israel
  • B'nai-Zion Medical Center
    Haifa, 31048, Israel

Showing the first 100 of 146 sites across 19 countries.

09

References and documents

Publications

  • Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6. PubMed 34741731 ↗
  • Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9. PubMed 34628605 ↗
  • Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747. PubMed 34531304 ↗
  • Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. PubMed 33830377 ↗
  • Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459. PubMed 33568389 ↗
  • Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453. PubMed 32918459 ↗
  • 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. PubMed 31302695 ↗
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Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00410384
Lead sponsor
Human Genome Sciences Inc.
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 12, 2006
Start date
Dec 2006
Primary completion
Sep 2009
Completion
Mar 2010
Results posted
May 5, 2011
Last update
Feb 1, 2017

Study contacts

GSK Clinical Trials
study director · Human Genome Sciences Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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