Belimumab Assessment of Safety in SLE

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2022
• Main ID: NCT01705977
• Date of registration: 10/10/2012
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Belimumab Assessment of Safety in SLE BASE
• Scientific 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
• Date of first enrolment: November 27, 2012
• Target sample size: 4019
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01705977
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Estonia, Hong Kong, Hungary, Indonesia, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Ukraine, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Other: Standard therapy

Biological: Belimumab 10 mg/kg plus standard therapy

Biological: Placebo plus standard therapy

Primary Outcome(s)

Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period [Time Frame: Up to Week 52 (On-treatment period)]

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)]

Number of Deaths - On Treatment Period [Time Frame: Up to Week 52 (On-treatment period)]

Secondary Outcome(s)

Number of Participants With SAEs Reported During On-study Period [Time Frame: Up to Week 52 (On-study period)]

Number of Participants Who Reported Protocol Defined AESI: On-study Period [Time Frame: Up to Week 52 (On-study period)]

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]

Number of Deaths Reported - On-study Period [Time Frame: Up to Week 52 (On-study period)]

Secondary ID(s)

115467

HGS1006-C1113

2011-005667-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01705977