A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

May 31, 2018 updated by: Human Genome Sciences Inc., a GSK Company

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
839

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
        • GSK Investigational Site
      • La Plata, Buenos Aires, Argentina, B1902COS
        • GSK Investigational Site
  • Austria
      • Vienna, Austria, A-1100
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1090
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • GSK Investigational Site
      • Salvador, Brazil, 40050-410
        • GSK Investigational Site
      • São Paulo, Brazil, 04032-060
        • GSK Investigational Site
    • Mato Grosso
      • Cuiaba, Mato Grosso, Brazil, 78005-000
        • GSK Investigational Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36038-330
        • GSK Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-080
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • GSK Investigational Site
      • Ruse, Bulgaria, 7002
        • GSK Investigational Site
      • Sofia, Bulgaria, 1784
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 7500000
        • GSK Investigational Site
      • Viña del Mar, Chile, 2570017
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7501126
        • GSK Investigational Site
  • Colombia
      • Barranquilla, Colombia
        • GSK Investigational Site
      • Bogota, Colombia
        • GSK Investigational Site
      • Bucaramanga, Colombia
        • GSK Investigational Site
      • Medellin, Colombia
        • GSK Investigational Site
  • Croatia
      • Osijek, Croatia, 31000
        • GSK Investigational Site
      • Rijeka, Croatia, 51000
        • GSK Investigational Site
      • Zagreb, Croatia, 10000
        • GSK Investigational Site
  • Czechia
      • Praha 2, Czechia, 128 50
        • GSK Investigational Site
      • Zlin, Czechia, 760 01
        • GSK Investigational Site
  • Denmark
      • Koebenhavn, Denmark, 2100
        • GSK Investigational Site
      • Odense C, Denmark, 5000
        • GSK Investigational Site
  • France
      • Paris, France, 75679
        • GSK Investigational Site
      • Paris cedex 13, France, 75651
        • GSK Investigational Site
      • Pessac Cedex, France, 33604
        • GSK Investigational Site
      • Strasbourg cedex, France, 67091
        • GSK Investigational Site
      • Suresnes, France, 92150
        • GSK Investigational Site
      • Vandoeuvre les Nancy, France, 54511
        • GSK Investigational Site
  • Germany
      • Frankfurt, Germany, 60590
        • GSK Investigational Site
      • Hamburg, Germany, 22081
        • GSK Investigational Site
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • GSK Investigational Site
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
  • Hungary
      • Debrecen, Hungary, 4032
        • GSK Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • GSK Investigational Site
  • Italy
      • Genova, Italy, 16132
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Japan
      • Fukuoka, Japan, 807-8555
        • GSK Investigational Site
      • Fukuoka, Japan, 810-8563
        • GSK Investigational Site
      • Hokkaido, Japan, 060-8648
        • GSK Investigational Site
      • Hokkaido, Japan, 060-8604
        • GSK Investigational Site
      • Miyagi, Japan, 980-8574
        • GSK Investigational Site
      • Nagasaki, Japan, 857-1195
        • GSK Investigational Site
      • Okinawa, Japan, 901-0243
        • GSK Investigational Site
      • Shizuoka, Japan, 430-8558
        • GSK Investigational Site
      • Tokyo, Japan, 160-8582
        • GSK Investigational Site
      • Tokyo, Japan, 162-8655
        • GSK Investigational Site
      • Tokyo, Japan, 104-8560
        • GSK Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • GSK Investigational Site
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 06700
        • GSK Investigational Site
      • Mexico, Mexico, 3100
        • GSK Investigational Site
      • San Luis Potosi, Mexico, 78240
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44158
        • GSK Investigational Site
      • Guadalajara, Jalisco, Mexico, 44690
        • GSK Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62270
        • GSK Investigational Site
    • Yucatán
      • Merida, Yucatán, Mexico, 97130
        • GSK Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • GSK Investigational Site
      • Davao City, Philippines, 8000
        • GSK Investigational Site
      • Iloilo City, Philippines, 5000
        • GSK Investigational Site
      • Las Pinas, Philippines, 1740
        • GSK Investigational Site
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Manila, Philippines, 1015
        • GSK Investigational Site
      • Quezon City, Philippines, 1102
        • GSK Investigational Site
      • Quezon City, Philippines, 1118
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • GSK Investigational Site
      • Katowice, Poland, 40-635
        • GSK Investigational Site
      • Krakow, Poland, 31-066
        • GSK Investigational Site
      • Wroclaw, Poland, 50-556
        • GSK Investigational Site
  • Portugal
      • Almada, Portugal, 2801-915
        • GSK Investigational Site
      • Amadora, Portugal, 2720-276
        • GSK Investigational Site
      • Coimbra, Portugal, 3000-075
        • GSK Investigational Site
      • Lisboa, Portugal, 1649-035
        • GSK Investigational Site
      • Porto, Portugal, 4099-001
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Bucharest, Romania, 11172
        • GSK Investigational Site
      • Bucuresti, Romania, 020475
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 190068
        • GSK Investigational Site
      • Yaroslavl, Russian Federation, 150030
        • GSK Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • GSK Investigational Site
      • Belgrade, Serbia, 11080
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 529889
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 8035
        • GSK Investigational Site
      • Granada, Spain, 18012
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
  • Taiwan
      • Gueishan Township,Taoyuan County, Taiwan, 333
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 833
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 813
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 807
        • GSK Investigational Site
      • Taichung, Taiwan, 404
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
      • Chiangmai, Thailand, 50200
        • GSK Investigational Site
      • Rajathevee, Thailand, 10400
        • GSK Investigational Site
      • Ratchatewi, Thailand, 10400
        • GSK Investigational Site
      • Songkla, Thailand, 90110
        • GSK Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61039
        • GSK Investigational Site
      • Kyiv, Ukraine, 01601
        • GSK Investigational Site
      • Odesa, Ukraine, 65026
        • GSK Investigational Site
      • Poltava, Ukraine, 36011
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21018
        • GSK Investigational Site
      • Zaporizhzhia, Ukraine, 69600
        • GSK Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • GSK Investigational Site
      • London, United Kingdom, SE1 7EH
        • GSK Investigational Site
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
    • California
      • La Jolla, California, United States, 92037-0943
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Los Angeles, California, United States, 90033
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Francisco, California, United States, 94118
        • GSK Investigational Site
      • San Jose, California, United States, 95126-1650
        • GSK Investigational Site
      • San Leandro, California, United States, 94578
        • GSK Investigational Site
      • Tustin, California, United States, 92780
        • GSK Investigational Site
      • Upland, California, United States, 91786
        • GSK Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
      • Boca Raton, Florida, United States, 33432
        • GSK Investigational Site
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33334
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806-6264
        • GSK Investigational Site
      • Plantation, Florida, United States, 33324
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30303
        • GSK Investigational Site
      • Duluth, Georgia, United States, 30096
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • GSK Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62704
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • GSK Investigational Site
      • Cumberland, Maryland, United States, 21502
        • GSK Investigational Site
      • Hagerstown, Maryland, United States, 21740
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Saint Clair Shores, Michigan, United States, 48081
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • GSK Investigational Site
      • Lake Success, New York, United States, 11042
        • GSK Investigational Site
      • Manhasset, New York, United States, 11030
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • Smithtown, New York, United States, 11787
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7280
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Greenville, North Carolina, United States, 27834
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43203
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45417
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • GSK Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • GSK Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29406
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29601
        • GSK Investigational Site
      • Orangeburg, South Carolina, United States, 29118
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
    • Texas
      • Allentown, Texas, United States, 75013
        • GSK Investigational Site
      • Austin, Texas, United States, 78705
        • GSK Investigational Site
      • Austin, Texas, United States, 78758
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
      • Houston, Texas, United States, 77004
        • GSK Investigational Site
      • Houston, Texas, United States, 77008
        • GSK Investigational Site
      • Houston, Texas, United States, 77034
        • GSK Investigational Site
      • Nassau Bay, Texas, United States, 77058
        • GSK Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205-3606
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98133
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • GSK Investigational Site
    • Wyoming
      • Pennsylvania, Wyoming, United States, 19610
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  3. Active SLE disease.
  4. Autoantibody-positive.
  5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
  3. Have received treatment an investigational biological agent in the past year.
  4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
  5. Have severe active lupus kidney disease.
  6. Have severe active central nervous system (CNS) lupus.
  7. Have required management of acute or chronic infections within the past 60 days.
  8. Have current drug or alcohol abuse or dependence.
  9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Biological: Placebo
Placebo
Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Experimental: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Biological: Belimumab 200 mg SC
Belimumab 200 mg SC
Other Names:
  • BENLYSTA™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Time Frame: Week 52
SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Time Frame: Baseline (Day 0, prior to dosing) to Week 52
Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.
Baseline (Day 0, prior to dosing) to Week 52
Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline
Time Frame: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Genome Sciences Inc., a GSK Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 112341
  • 2011-003814-18
  • HGS1006-C1115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: 112341
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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