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Clinical trial

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

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Last updated:5th Jun 2018
Status: Completed
Identifier: NCT01484496
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)


Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Detailed Description:
This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.


Study Type: Interventional (Clinical Trial)
Actual Enrollment: 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Study Start Date: November 16, 2011
Actual Primary Completion Date: February 13, 2015
Actual Study Completion Date: October 1, 2015

Arm:
- Placebo Comparator: Placebo plus standard therapy
- Experimental: Belimumab 200 mg SC plus standard therapy

Category Value
Study type(s) Interventional
Expected enrolment 839
Study start date 16 November 2011
Actual Study Completion Date 01 October 2015

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