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BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

NCT01597622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2020-03-27

Study results available
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Summary

This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

Conditions

Interventions

DRUG

Belimumab

10 mg/kg administered intravenously over 1 hour every 4 weeks

Sponsors & Collaborators

  • Human Genome Sciences Inc.

    collaborator INDUSTRY

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-11
Primary Completion
2018-09-13
Completion
2018-09-13

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597622 on ClinicalTrials.gov