Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)

This study is currently recruiting participants.
Verified March 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01632241
First received: June 28, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Placebo plus standard therapy
Biological: Belimumab 10 mg/kg plus standard therapy
Drug: Standard therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Response rate at 52 weeks, measured by the SLE Responder Index (SRI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    A participant that has an SRI response has all 3 of the following:

    • ≥4 point reduction from baseline in Safety of Estrogen in Lupus National Assessment SLE Disease Activity Index (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).


Secondary Outcome Measures:
  • Time to first severe flare (SLE Flare Index) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
  • Reduction in prednisone dose [ Time Frame: Baseline, weeks 40 to 52 ] [ Designated as safety issue: No ]
    Percent of participants whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 in participants receiving greater than 7.5 mg/day at baseline.

  • Number of participants who experienced adverse events [ Time Frame: up to 84 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 816
Study Start Date: February 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus standard therapy
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Biological: Placebo plus standard therapy
Placebo plus standard therapy
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 10 mg/kg plus standard therapy
Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.
Biological: Belimumab 10 mg/kg plus standard therapy
Belimumab 10mg/kg plus standard therapy
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.

Detailed Description:

Study participants receive stable standard therapy for lupus in addition to receiving either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "2 to 1" which means that for every 3 participants, 2 will receive belimumab and 1 will receive placebo. Participants who successfully complete the 52-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab plus standard therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Black race.
  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).

Key Exclusion Criteria:

  • Pregnant or nursing.
  • Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab) at any time.
  • Have received treatment with an investigational biological agent in the past year.
  • Have received intravenous (IV) cyclophosphamide within the past 90 days.
  • Have severe active lupus kidney disease.
  • Have severe 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.
  • Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • Have a history of severe allergic reaction to contrast agents or biological medicines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632241

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 69 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01632241     History of Changes
Other Study ID Numbers: 115471, HGS1006-C1112, 2011-005672-42, U1111-1139-9723
Study First Received: June 28, 2012
Last Updated: March 27, 2014
Health Authority: Brazil: National Health Surveillance Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Systemic Lupus Erythematosus
African Continental Ancestry Group
Autoimmune Disease
Antibodies
Minority Groups
Black Race
African Americans
SLE
Belimumab
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014