A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Belimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00583362

112626

Details and patient eligibility

About

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Full description

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.

2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.

3. Used any of the following prohibited medications during their participation in LBSL02:

   • Other investigational agents.
   • Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
   • Intravenous cyclophosphamide.
   • Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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298 participants in 1 patient group

Belimumab 10 mg/kg

Experimental group

Description:

Belimumab 10 mg/kg IV over one hour every 28 days.

Treatment:

Biological: Belimumab