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NCT03312907COMPLETEDanonymous

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

Sponsor

Source record

GlaxoSmithKline

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Indication / condition

AI-normalized

Systemic Lupus Erythematosus

Intervention

Source record

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Source & freshness

Source record

NCT ID

NCT03312907

Original source

ClinicalTrials.gov

Source last updated

Feb 18, 2025

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03312907

Title

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

Sponsor

GlaxoSmithKline

Status

COMPLETED

Phase

PHASE3

Condition raw

Systemic Lupus Erythematosus

Condition normalized

Systemic Lupus Erythematosus

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Target normalized

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Interventions

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Public preview

Source record

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03312907

Status

COMPLETED

Phase

PHASE3

Sponsor

GlaxoSmithKline

Executive brief

Investment-Ready Snapshot

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedFeb 18, 2025
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03312907

Indication

Systemic Lupus Erythematosus

Modality

monoclonal antibody

Target

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Intervention

Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.