Belimumab Assessment of Safety in SLE (BASE)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Belimumab 10 mg/kg plus standard therapy; Other: Standard therapy; Biological: Placebo plus standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01705977

HGS1006-C1113 (Other Identifier)

115467

2011-005667-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,019 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,019 participants in 2 patient groups, including a placebo group

Placebo plus standard therapy

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo plus standard therapy

Other: Standard therapy

Belimumab 10 mg/kg plus standard therapy

Experimental group

Description:

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.

Treatment:

Other: Standard therapy

Biological: Belimumab 10 mg/kg plus standard therapy