A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: belimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712933

2007-007648-85 (EudraCT Number)

112234

Details and patient eligibility

About

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Full description

This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Enrollment: 738 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Exclusion criteria

• Have developed any other medical disease or condition that has made the patient 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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738 participants in 2 patient groups

1

Experimental group

Description:

1 mg/kg dose of belimumab given IV every 28 days.

Treatment:

Drug: belimumab

2.

Experimental group

Description:

10 mg/kg dose of belimumab given IV every 28 days.

Treatment:

Drug: belimumab