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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Placebo

Drug: Belimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01345253

113750

Details and patient eligibility

About

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.

Full description

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.

Enrollment

709 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.