GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by GlaxoSmithKline
Sponsor:
Collaborator:
Human Genome Sciences Inc., a GSK Company
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01345253
First received: April 28, 2011
Last updated: July 11, 2013
Last verified: June 2013

April 28, 2011
July 11, 2013
May 2011
January 2015   (final data collection date for primary outcome measure)
SLE Responder Index (SRI) Response Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
At Week 52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment.
Same as current
Complete list of historical versions of study NCT01345253 on ClinicalTrials.gov Archive Site
  • Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • SLE Responder Index (SRI) 7 Response Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    At Week 52, the percent of subjects with ≥ 7 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment.
  • Number of days of daily prednisone dose ≤ 7.5 mg/day and/or reduced by 50% from baseline over 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to severe SFI flare over 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Belimumab
    10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
  • Drug: Placebo
    Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
  • Experimental: Belimumab
    10mg/kg
    Intervention: Drug: Belimumab
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
February 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years and older.
  • Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
  • Have active SLE disease.
  • Have positive anti-nuclear antibody (ANA) test results.
  • Are on a stable SLE treatment regimen.
  • Females of childbearing age are willing to use appropriate contraception

Exclusion Criteria:

  • Have received treatment with any B cell targeted therapy at any time.
  • Have received a biologic investigational agent in the past year.
  • Have received 3 or more courses of systemic corticosteroids in the past year.
  • Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have had a major organ transplant.
  • Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
  • Have a planned surgical procedure.
  • Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
  • Have required management of acute or chronic infections in 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.
  • Have an IgA deficiency.
  • Have severe laboratory Abnormalities.
  • Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
  • Suicidal behavior or ideation.
Both
18 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
China,   Japan,   Korea, Republic of
 
NCT01345253
113750
No
GlaxoSmithKline
GlaxoSmithKline
Human Genome Sciences Inc., a GSK Company
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

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