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Belimumab Assessment of Safety in SLE (BASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705977
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Placebo plus standard therapy Biological: Belimumab 10 mg/kg plus standard therapy Other: Standard therapy Phase 4

Detailed Description:

Study participants receive standard therapy for SLE in addition to receiving the study drug, either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. After completion of the 52-week study period, participants will be contacted by phone annually for 4 more years to assess health status.

Following the 52-week controlled period, participants who wish to continue treatment with belimumab may be able to do so by being prescribed commercially available belimumab. If belimumab is not commercially available in the participant's country, the participant may be able to receive belimumab under a separate continuation protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4019 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
Actual Study Start Date : November 27, 2012
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : August 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: Placebo plus standard therapy
Placebo plus standard therapy

Other: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics 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.
 Biological: Belimumab 10 mg/kg plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Other Name: BENLYSTA™

Other: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Deaths - On Treatment Period [ Time Frame: Up to Week 52 (On-treatment period) ]
    Number of participants who died during on-treatment period is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (>50%) of the time. The on-treatment period was the primary analysis period for safety analyses.

  2. Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period [ Time Frame: Up to Week 52 (On-treatment period) ]
    A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.

  3. Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period [ Time Frame: Up to Week 52 (On-treatment period) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.


Secondary Outcome Measures :
  1. Number of Deaths Reported - On-study Period [ Time Frame: Up to Week 52 (On-study period) ]
    Number of participants who died during on-study period is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

  2. Number of Participants Who Reported Protocol Defined AESI: On-study Period [ Time Frame: Up to Week 52 (On-study period) ]
    A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

  3. Number of Participants With SAEs Reported During On-study Period [ Time Frame: Up to Week 52 (On-study period) ]
    A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.

  4. Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 [ Time Frame: Week 40 to Week 52 ]
    The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage 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 with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
  • Have received a live vaccine within the past 30 days.
  • Have severe active lupus kidney disease.
  • Have severe active central nervous system (CNS) lupus.
  • Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705977


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] May 22, 2017
Statistical Analysis Plan  [PDF] October 18, 2018

More Information
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Publications:
Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01705977    
Other Study ID Numbers: 115467
2011-005667-25 ( EudraCT Number )
HGS1006-C1113 ( Other Identifier: Human Genome Sciences Inc. )
First Posted: October 15, 2012    Key Record Dates
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study is available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=20766
Keywords provided by GlaxoSmithKline:
Antibodies
Lupus
SLE
 Systemic Lupus Erythematosus
Autoimmune Disease
Belimumab
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs