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Monoclonal Antibodies

Standard therapy for Lupus (BASE Trial)

Phase 4
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2 years to 5 years
Awards & highlights

BASE Trial Summary

This trial is looking at the side effects of belimumab when used in conjunction with other lupus medications in adults. The focus is on serious but rare events such as death, cancer, and mental health problems. The goal is to see if belimumab increases the risk for these events and if patients receiving belimumab can reduce their use of steroids over the course of a year.

Eligible Conditions
  • Lupus

BASE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2 years to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 2 years to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Deaths - On Treatment Period (Week 52)
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
Secondary outcome measures
Number of Deaths Reported - On-study Period (Week 52)
Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
Number of Participants With All-cause Mortality During Years 2 to 5
+3 more

Side effects data

From 2022 Phase 4 trial • 4019 Patients • NCT01705977
1%
Herpes zoster
1%
Pneumonia
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belimumab 10 mg/kg
Placebo

BASE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Belimumab 10 mg/kg plus standard therapyExperimental Treatment2 Interventions
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.
Group II: Placebo plus standard therapyPlacebo Group2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Belimumab 10 mg/kg plus standard therapy
2012
Completed Phase 4
~4970

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,749 Previous Clinical Trials
8,063,409 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,139,911 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Belimumab Assessment of Safety in SLE
2012. "Belimumab Assessment of Safety in SLE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01705977.
~326 spots leftby Apr 2025
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