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

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ClinicalTrials.gov Identifier: NCT01484496
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : July 25, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Tracking Information
First Submitted Date  ICMJE November 28, 2011
First Posted Date  ICMJE December 2, 2011
Results First Submitted Date January 30, 2017
Results First Posted Date July 25, 2017
Last Update Posted Date June 5, 2018
Study Start Date  ICMJE November 16, 2011
Actual Primary Completion Date February 13, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
SLE Responder Index (SRI) response rate [ Time Frame: Baseline, 52 Weeks ]
A patient that has an SRI response has all 3 of the following: • ≥4 point reduction from baseline in SELENA SLEDAI score, AND • No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA), AND • No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52).
Change History Complete list of historical versions of study NCT01484496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • Time to first severe flare (SLE Flare Index) [ Time Frame: Baseline to 52 weeks ]
  • Reduction in prednisone dose [ Time Frame: Baseline, Weeks 40-52 ]
    Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 in subjects receiving greater than 7.5 mg/day at baseline.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE 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)
Brief Summary 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).
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  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Biological: Placebo
    Placebo
  • Biological: Belimumab 200 mg SC
    Belimumab 200 mg SC
    Other Name: BENLYSTA™
  • 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.
Study Arms
  • 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.
    Interventions:
    • Biological: Placebo
    • Drug: Standard therapy
  • 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.
    Interventions:
    • Biological: Belimumab 200 mg SC
    • Drug: Standard therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
839
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
816
Actual Study Completion Date October 1, 2015
Actual Primary Completion Date February 13, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hungary,   Italy,   Japan,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Spain,   Sweden,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01484496
Other Study ID Numbers  ICMJE 112341
2011-003814-18
HGS1006-C1115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Responsible Party GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Study Sponsor  ICMJE Human Genome Sciences Inc., a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2018

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