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01
Overview
Phase 3, randomised, double-blind trial in lupus nephritis (LN) comparing Belimumab + SoC with Placebo + SoC (2 arms). Primary endpoints: Primary Efficacy Renal Response at 104 weeks, Adverse Events and Serious Adverse Events and 1 more. Started Jul 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Belimumab + SoC
Belimumab 10 mg/kg IV every 28 days + Standard Therapy
Placebo + SoC
Placebo IV every 28 days + Standard Therapy
03
Who it enrols
Adult patients with active lupus nephritis (Class III, IV, or V) and autoantibody-positive SLE, requiring induction therapy.
04
Endpoints
Primary
Primary Efficacy Renal Response
Adverse Events and Serious Adverse Events
Adverse Events of Special Interest
Secondary
Complete Renal Response
Primary Efficacy Renal Response at Week 52
Time to Death or Renal Related Event
Ordinal Renal Response
On-treatment Adverse Events and Serious Adverse Events
Adverse Events of Special Interest (Double-blind)
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