A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

Phase 3

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Belimumab 1 mg/kg; Drug: Belimumab 10 mg/kg; Drug: Placebo

• Registration Number: NCT00410384
• Lead Sponsor: Human Genome Sciences Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-08
• Study First Submitted QC: 2006-12-08
• Study First Posted: 2006-12-12
• Primary Completion: 2009-09
• Study Completion: 2010-03
• Disposition First Submitted: 2010-10-21
• Disposition First Submitted QC: 2010-10-21
• Disposition First Posted: 2010-10-25
• Results First Submitted: 2011-04-07
• Results First Submitted QC: 2011-04-07
• Results First Posted: 2011-05-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

Inclusion Criteria

• Clinical diagnosis of SLE by ACR criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen.

Key

Exclusion Criteria

• Pregnant or nursing
• Have received treatment with any B cell targeted therapy.
• Have received treatment with a biological investigational agent in the past year.
• Have received IV cyclophosphamide within 180 days of Day 0.
• Have severe lupus kidney disease.
• Have active central nervous system (CNS) lupus.
• Have required management of acute or chronic infections within the past 60 days.
• Have current drug or alcohol abuse or dependence.
• Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Belimumab 1 mg/kg	Belimumab 1 mg/kg	Belimumab 1 mg/kg
Belimumab 10 mg/kg	Belimumab 10 mg/kg	Belimumab 10 mg/kg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
SLE Responder Index (SRI) Response Rate at Week 52	Baseline, 52 Weeks	Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.; SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

Secondary Outcome Measures

Name	Time	Method
SRI Response Rate at Week 76	Baseline, 76 Weeks	Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.; SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.	Baseline, 52 Weeks
Mean Change in Physician's Global Assessment (PGA) at Week 24.	Baseline, 24 Weeks	The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.	Baseline, 24 Weeks	The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52	Baseline, Weeks 40-52

Trial Locations

Locations (146)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Arthritis and Rheumatology Research, PPLC; 🇺🇸 Paradise Valley, Arizona, United States

The University of Arizona Arthritis Center; 🇺🇸 Tucson, Arizona, United States

Talbert Medical Group; 🇺🇸 Huntington Beach, California, United States

Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.; 🇺🇸 Long Beach, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Wallace Rheumatic Study Center; 🇺🇸 Los Angeles, California, United States

UCLA Rheumatology; 🇺🇸 Los Angeles, California, United States

Arthritis Care Center, Inc.; 🇺🇸 San Jose, California, United States

Inland Rheumatic Disease Specialties; 🇺🇸 Upland, California, United States

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