Phase 3
Completed N=268
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
Source: ClinicalTrials.gov NCT00724867 ↗Enrolled (actual)
268
Serious AEs
41.8%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) — 267; 260; 235; 206 Participants
◆ Published Evidence
Established
95citations · ~12 / year
Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States.
Summary
This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.
Linked Publications (2)
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Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States.
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Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) |
267; 260; 235; 206; 184; 167 | — |
| PRIMARY AE Rates by System Organ Class (SOC) During the Study |
134.4; 75.5; 53.6; 32.3; 30; 29.7 | — |
| PRIMARY SAE Rates by System Organ Class (SOC) During the Study |
4; 2.2; 2; 1.7; 1.4; 1.4 | — |
| PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points |
1.3; 1; 0.7; 1.4; 1.7; 2.7 | — |
| PRIMARY Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points |
0.001; 0.002; 0.003; 0.003; 0.001; 0.002 | — |
| PRIMARY Change From Baseline in Erythrocytes at the Indicated Time Points |
0; 0.01; 0.04; 0.03; 0.06; 0.06 | — |
| PRIMARY Change From Baseline in Hematocrit at the Indicated Time Points |
0.16; 0.11; 0.31; 0.2; 0.73; 0.81 | — |
| PRIMARY Change From Baseline in Hemoglobin at the Indicated Time Points |
0; 0.3; 0.5; 0.5; 2.1; 2.5 | — |
| PRIMARY Change From Baseline in Albumin and Protein at the Indicated Time Points |
-0.3; 0.1; 0.3; 0.4; 1.1; 1.1 | — |
| PRIMARY Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points |
0.026; -0.1695; -0.1612; -0.1732; -0.1013; -0.1873 | — |
| PRIMARY Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points |
-0.2; -0.5; -0.6; -0.4; -0.2; -0.2 | — |
| PRIMARY Change From Baseline in Creatinine Clearance at the Indicated Time Points |
-0.022; 0.01; 0.028; 0.034; 0.017; 0.047 | — |
| PRIMARY Change From Baseline in BUN/Creatinine at the Indicated Time Points |
-0.2; -0.5; -0.6; -0.4; -0.2; -0.2 | — |
| PRIMARY Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points |
0.5; -0.5; -0.1; 0.3; 0.4; 0.8 | — |
| PRIMARY Number of Participants With the Indicated Immunogenic Response |
262; 251; 239; 213; 195; 185 | — |
| PRIMARY Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. |
74.3; 74.5; 73.5; 74.5; 73.5; 73.6 | — |
| PRIMARY Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. |
7.7; 23.2; 3.8; 20.3; 2.7; 8.3 | — |
| PRIMARY 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. |
16.7; 33.3; 20; 0; 33.3; 0 | — |
| SECONDARY Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. |
8; 14; 16; 19; 17; 26 | — |
| SECONDARY Percentage of Participants Achieving SRI Response at Indicated Time Points |
41.9; 45.3; 49.3; 49; 51.2; 58.4 | — |
| SECONDARY Observed Anti-double Stranded DNA Levels at Indicated Time Points. |
193; 127.5; 123; 93.5; 95; 82.5 | — |
| SECONDARY Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. |
-9.77; -15.58; -27.5; -30.12; -34.22; -34.92 | — |
| SECONDARY Observed Complement C3 and C4 Levels at Indicated Time Points |
76; 80; 86; 85; 88.5; 90.5 | — |
| SECONDARY Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points |
10.91; 17.86; 18.64; 16.71; 24.26; 22.73 | — |
| SECONDARY Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. |
2.5; 21; 38.5; 40.8; 50; 41.3 | — |
| SECONDARY Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. |
41.2; 63.6; 60.6; 53.3; 74.2; 67.9 | — |
| SECONDARY Observed B-cell Levels at Indicated Time Points. |
112.5; 68; 50; 37.5; 34; 31 | — |
| SECONDARY Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. |
-31.82; -51.61; -61.76; -66.21; -69.68; -72.77 | — |
| SECONDARY Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points |
5.7; 12.1; 18; 20.8; 22.6; 25.1 | — |
| SECONDARY Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point |
2.47; 2.99; 2.54; 2.52; 2.22; 2.71 | — |
| SECONDARY Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints |
9.7; 9.2; 10.97; 8.33; 10.88; 8.82 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point |
4.91; 4.82; 4.85; 4.14; 4.81; 3.7 | — |
| SECONDARY Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points |
50.4; 45.9; 44.4; 36.2; 40.3; 33.2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00724867) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.