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HGS1006-C1074: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B TM), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057.

HGS1006-C1074: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B TM), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/091/000219
Enrollment
1000
Registered
2011-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Belimumab: 1 Mg/Kg every 28 days Intervention2: Belimumab: 10 Mg/Kg Every 28 Days Control Intervention1: NIL: NIL

Sponsors

Human Genome Sciences, Inc. 14200 Shady Grove Road Rockville, Maryland 20850, USA
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Long-Term Safety Evaluation Of Belimumab (LymphoStat-B TM) In Subjects With SLE.Timepoint: Ongoing—

Secondary

MeasureTime frame
The SLICC/ACR Damage IndexTimepoint: Every 48 Weeks And At Exit Visit.—

Countries

India

Contacts

Public ContactAnuraag Priyadarshini
shaikh.ataali@kendle.com01244536357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026