Phase 3
Completed N=735
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Source: ClinicalTrials.gov NCT00712933 ↗Enrolled (actual)
735
Serious AEs
31.4%
Results posted
Jan 2018
Primary outcomePrimary: Number of Participants With Adverse Events (AE) — 706; 617; 502; 441 Participants
◆ Published Evidence
Established
84citations · ~14 / year
Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.
Summary
This is a long-term continuation study to provide continuing treatment to subjects with SLE.
Linked Publications (2)
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Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.
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Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) |
706; 617; 502; 441; 344; 261 | — |
| PRIMARY AE Rates by System Organ Class (SOC) During the Study |
101.8; 32.8; 32.8; 22.6; 22.5; 14.9 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAE) |
231; 78; 58; 66; 44; 27 | — |
| PRIMARY SAE Rates by SOC During the Study |
5.1; 1.0; 1.0; 1.0; 0.8; 0.8 | — |
| PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points |
0.7; 2.1; 0.1; 2.5; 0.8; 2.7 | — |
| PRIMARY Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points |
0.002; 0.002; 0.002; 0.002; 0.003; 0.004 | — |
| PRIMARY Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points |
-0.3; 0.1; 0.1; 0.3; 1.0; 1.0 | — |
| PRIMARY Change From Baseline in Hematocrit at the Indicated Time Points |
0.01; 0.38; 0.75; 0.53; 0.35; 0.94 | — |
| PRIMARY Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points |
-0.00; 0.04; 0.06; 0.06; 0.06; 0.07 | — |
| PRIMARY Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points |
0.0030; 0.0020; -0.0035; 0.0024; -0.0065; -0.0075 | — |
| PRIMARY Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points |
-0.2; -0.3; -0.7; -0.5; -0.2; -0.1 | — |
| PRIMARY Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points |
-0.1; 0.2; 0.6; 0.7; 1.2; 1.2 | — |
| PRIMARY Change From Baseline in BUN and Glucose at the Indicated Time Points |
0.0299; 0.0402; -0.1443; -0.0592; -0.0406; -0.0760 | — |
| PRIMARY Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points |
1.0332; 0.4089; -0.0510; 0.6713; -1.5147; 2.7246 | — |
| PRIMARY Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels |
-0.4; -0.9; -0.9; -1.0; -0.7; 0.2 | — |
| PRIMARY Change From Baseline in Bilirubin (Bili) Levels |
0.142; 0.008; 0.217; 0.173; 0.367; 0.488 | — |
| PRIMARY Change From Baseline in Immunoglobulin G (IgG) Levels |
-1.571; -1.963; -2.507; -3.058; -3.232; -3.453 | — |
| PRIMARY Number of Participants With Immunogenic Response by Year |
707; 656; 577; 498; 432; 336 | — |
| PRIMARY Number of Participants With IgG Values Below the Lower Limit of Normal by Year |
6; 64; 22; 24; 22; 19 | — |
| PRIMARY Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit |
40; 5; 1; 0; 1; 194 | — |
| PRIMARY Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit |
39; 50; 56; 57; 51; 41 | — |
Eligibility 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
- Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Data sourced from ClinicalTrials.gov (NCT00712933) 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.