A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Belimumab 10 mg/kg; Biological: Belimumab 1 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724867

HGS1006-C1066 (Other Identifier)

112233

Details and patient eligibility

About

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

Full description

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
• Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Exclusion criteria

• Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Belimumab 1 mg/kg

Experimental group

Description:

Belimumab 1 mg/kg IV every 28 days

Treatment:

Biological: Belimumab 1 mg/kg

Belimumab 10 mg/kg

Experimental group

Description:

Belimumab 10 mg/kg IV every 28 days

Treatment:

Biological: Belimumab 10 mg/kg