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| ID | Type | Description | Link |
|---|---|---|---|
| 112232 | Other Identifier | GlaxoSmithKline |
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Sponsor terminated study for business reasons.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab Q2WKS | Experimental | Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period. |
|
| Belimumab 3X/WK | Experimental | Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab 100 mg SC | Drug | Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | SEE ALSO ADVERSE EVENTS RESULTS SECTION | Up to 24 weeks |
| Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 | Baseline, 24 weeks | |
| Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. | Baseline, 24 Weeks | |
| Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 | Baseline, 24 weeks | |
| Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 | Baseline, 24 weeks | |
| Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Baseline, 24 Weeks | |
| Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Baseline, 24 Weeks | |
| Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Baseline, 24 Weeks | |
| Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Baseline, 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. | Baseline, 24 weeks | |
| Absolute Change From Baseline in IgA at Week 24 | Baseline, 24 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249-7201 | United States | ||
| Valerious Medical Group Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31302695 | Derived | van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab SC Q2WKS | 100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period. |
| FG001 | Belimumab SC 3X/WK |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Belimumab 100 mg SC | Drug | Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week. |
|
| Median Percent Change From Baseline in IgA at Week 24 |
| Baseline, 24 weeks |
| Absolute Change From Baseline in IgG at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in IgG at Week 24 | Baseline, 24 Weeks |
| Absolute Change From Baseline in IgM at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in IgM at Week 24 | Baseline, 24 weeks |
| Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | 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. | Baseline, 24 Weeks |
| Mean Percent Change From Baseline in PGA Score at Week 24. | 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. | Baseline, 24 weeks |
| Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 | SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. | Baseline, 24 Weeks |
| Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 | Baseline, 24 weeks |
| Absolute Change From Baseline in Complement C3 at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in Compliment C3 at Week 24 | Baseline, 24 Weeks |
| Absolute Change From Baseline in Complement C4 at Week 24 | Baseline, 24 weeks |
| Median Percent Change From Baseline in Complement C4 at Week 24 | Baseline, 24 Weeks |
| Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in Anti-dsDNA at Week 24 | Baseline, 24 weeks |
| Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in HDL at Week 24 | Baseline, 24 week |
| Absolute Change From Baseline in Total Cholesterol at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in Total Cholesterol at Week 24 | Baseline, 24 Weeks |
| Median Percent Change From Baseline in Triglycerides at Week 24 | Baseline, 24 weeks |
| Absolute Change From Baseline in Triglycerides at Week 24 | Baseline, 24 Weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Tampa Medical Group, PA | Tampa | Florida | 33614 | United States |
| Fiechtner Research, Inc. | Lansing | Michigan | 48910 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| North Shore-LIJ Health System/Rheumatology, Allergy, Immunology | Lake Success | New York | 11042 | United States |
| Rheumatology Associates | Smithtown | New York | 11787 | United States |
| STAT Research, Inc. | Dayton | Ohio | 45408 | United States |
| Oklahoma Center for Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | United States |
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
| Hospital Central "Igancio Morones Prieto" | San Lusi Potosi | 78240 | Mexico |
200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period. |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab SC Q2WKS | |
| BG001 | Belimumab SC 3X/WK | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. | SEE ALSO ADVERSE EVENTS RESULTS SECTION | Please see Adverse Events Section | Posted | Number | Percentage of participants | Up to 24 weeks |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Deviation | µg/mL | Baseline, 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in IgA at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | g/L | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in IgA at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in IgG at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | g/L | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in IgG at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in IgM at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | g/L | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in IgM at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | cells/mm^3 | Baseline, 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | cells/mm^3 | Baseline, 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 weeks |
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| |||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | cells/mL | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | cells/mm^3 | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | 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. | Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Error | Scores on a 3-point scale | Baseline, 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in PGA Score at Week 24. | 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. | LOCF | Posted | Mean | Standard Error | Percentage | Baseline, 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 | SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. | LOCF | Posted | Mean | Standard Error | Points on a scale | Baseline, 24 Weeks |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 | LOCF | Posted | Mean | Standard Error | Percentage | Baseline, 24 weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Complement C3 at Week 24 | Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | mg/L | Baseline, 24 Weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in Compliment C3 at Week 24 | Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Complement C4 at Week 24 | Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | mg/dL | Baseline, 24 weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in Complement C4 at Week 24 | Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 | Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | IU/mL | Baseline, 24 Weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in Anti-dsDNA at Week 24 | Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | mmol/L | Baseline, 24 Weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Percent Change From Baseline in HDL at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 week |
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| Secondary | Absolute Change From Baseline in Total Cholesterol at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | mmol/L | Baseline, 24 Weeks |
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| Secondary | Median Percent Change From Baseline in Total Cholesterol at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 Weeks |
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| Secondary | Median Percent Change From Baseline in Triglycerides at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Median | Full Range | Percentage | Baseline, 24 weeks |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Triglycerides at Week 24 | Analysis population includes all patients with both a baseline and Week 24 laboratory sample. | Posted | Mean | Standard Error | mmol/L | Baseline, 24 Weeks |
|
|
Up to 24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belimumab SC Q2WKS | The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter. | 2 | 28 | 19 | 28 | ||
| EG001 | Belimumab SC 3X/WK | The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter. | 4 | 28 | 18 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| SLE arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
For multi-center trials,no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months if indicated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
Not provided
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| Male |
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