A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00724867
• Date of registration: 28/07/2008
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences Inc., a GSK Company
• Public title: A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
• Scientific title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States
• Date of first enrolment: August 2008
• Target sample size: 268
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00724867
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.

- Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose
in HGS1006-c1056.

Exclusion Criteria:

- Have developed any other medical disease or condition that has made the subject
unsuitable for this study in the opinion of their physician.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Belimumab 10 mg/kg

Biological: Belimumab 1 mg/kg

Primary Outcome(s)

Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points [Time Frame: Up to Week 432]

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in Creatinine Clearance at the Indicated Time Points [Time Frame: Up to Week 440]

Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) [Time Frame: Up to Week 440]

Number of Participants With the Indicated Immunogenic Response [Time Frame: Up to Week 440]

Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. [Time Frame: Up to Week 440]

Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points [Time Frame: Up to Week 440]

AE Rates by System Organ Class (SOC) During the Study [Time Frame: Up Week 440]

SAE Rates by System Organ Class (SOC) During the Study [Time Frame: Up to Week 440]

Change From Baseline in Erythrocytes at the Indicated Time Points [Time Frame: Up to Week 440]

Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. [Time Frame: Up to Week 440]

Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in Hemoglobin at the Indicated Time Points [Time Frame: Up to Week 440]

Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. [Time Frame: Up to Week 432]

Change From Baseline in Hematocrit at the Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in BUN/Creatinine at the Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in Albumin and Protein at the Indicated Time Points [Time Frame: Up to Week 440]

Secondary Outcome(s)

Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. [Time Frame: Up to Week 432]

Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points [Time Frame: Up to Week 432]

Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. [Time Frame: Up to Week 432]

Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. [Time Frame: Up to Week 392]

Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. [Time Frame: Up to Week 432]

Observed Complement C3 and C4 Levels at Indicated Time Points [Time Frame: Up to Week 440]

Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point [Time Frame: Up to Week 384]

Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point [Time Frame: Up to Week 384]

Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. [Time Frame: Up to Week 432]

Observed Anti-double Stranded DNA Levels at Indicated Time Points. [Time Frame: Up to Week 432]

Observed B-cell Levels at Indicated Time Points. [Time Frame: Up to Week 432]

Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points [Time Frame: Up to Week 384]

Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints [Time Frame: Up to Week 384]

Percentage of Participants Achieving SRI Response at Indicated Time Points [Time Frame: Up to Week 440]

Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points [Time Frame: Up to Week 384]

Secondary ID(s)

112233

HGS1006-C1066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 28/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00724867