Trial Outcomes & Findings for Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE) (NCT NCT00732940)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Baseline, 24 Weeks

Results posted on

2013-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Belimumab SC 3X/WK 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.
Overall Study STARTED	28	28
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Belimumab SC 3X/WK 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.
Overall Study Withdrawal by Subject	1	2
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants	Total n=56 Participants Total of all reporting groups
Age Continuous	39.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	40.9 years STANDARD_DEVIATION 13.1 • n=7 Participants	40.1 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Mexico	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Please see Adverse Events Section

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. Percent of patients with at least 1 AE	89.3 Percentage of participants	85.7 Percentage of participants
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. Percent of patients with at least 1 Serious AE	7.1 Percentage of participants	14.3 Percentage of participants
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. Percent of patients with an AE resulting in death	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24	-53.5 cells/mm^3 Standard Error 20.4	-75.3 cells/mm^3 Standard Error 23.6

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.	-33.5 Percentage Full Range 8.88 • Interval -86.3 to 55.2	-38.2 Percentage Full Range 13.26 • Interval -86.3 to 130.8

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24	-81.9 cells/mm^3 Standard Error 18.5	-95.0 cells/mm^3 Standard Error 20.8

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24	-60.9 Percentage Full Range 6.47 • Interval -89.6 to 4.8	-66.7 Percentage Full Range 8.0 • Interval -90.2 to 85.7

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=24 Participants	Belimumab SC 3X/WK n=23 Participants
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24	1100.3 cells/mL Standard Error 389.8	-77.2 cells/mL Standard Error 456.9

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=24 Participants	Belimumab SC 3X/WK n=23 Participants
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24	45.2 Percentage Interval -69.6 to 1496.3	10.2 Percentage Interval -87.0 to 779.6

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24	27.7 cells/mm^3 Standard Error 6.0	19.6 cells/mm^3 Standard Error 6.2

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=23 Participants	Belimumab SC 3X/WK n=23 Participants
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24	84.2 Percentage Interval -37.5 to 288.9	100.0 Percentage Interval -45.5 to 600.0

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=26 Participants
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.	20.5 µg/mL Standard Deviation 11.6	120.8 µg/mL Standard Deviation 53.7

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=26 Participants	Belimumab SC 3X/WK n=25 Participants
Absolute Change From Baseline in IgA at Week 24	-0.3 g/L Standard Error 0.08	-0.3 g/L Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=26 Participants	Belimumab SC 3X/WK n=25 Participants
Median Percent Change From Baseline in IgA at Week 24	-8.1 Percentage Interval -45.1 to 15.4	-10.7 Percentage Interval -36.4 to 34.1

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Absolute Change From Baseline in IgG at Week 24	-2.2 g/L Standard Error 0.7	-1.4 g/L Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Median Percent Change From Baseline in IgG at Week 24	-11.1 Percentage Interval -47.0 to 12.1	-9.5 Percentage Interval -42.9 to 94.0

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Absolute Change From Baseline in IgM at Week 24	-0.3 g/L Standard Error 0.04	-0.4 g/L Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Median Percent Change From Baseline in IgM at Week 24	-25.6 Percentage Interval -80.0 to 11.0	-26.9 Percentage Interval -71.6 to 170.6

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Last Observation Carried Forward (LOCF)

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.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24	-0.4 Scores on a 3-point scale Standard Error 0.09	-0.4 Scores on a 3-point scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: LOCF

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.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants
Mean Percent Change From Baseline in PGA Score at Week 24.	-26.1 Percentage Standard Error 6.6	-24.8 Percentage Standard Error 13.1

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: LOCF

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24	-2.9 Points on a scale Standard Error 0.8	-3.1 Points on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: LOCF

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=28 Participants	Belimumab SC 3X/WK n=28 Participants
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24	-35.8 Percentage Standard Error 9.1	-40.5 Percentage Standard Error 8.6

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes only patients with low C3 (\<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=5 Participants	Belimumab SC 3X/WK n=10 Participants
Absolute Change From Baseline in Complement C3 at Week 24	188.0 mg/L Standard Error 51.5	4.0 mg/L Standard Error 44.3

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes only patients with low C3 (\<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=5 Participants	Belimumab SC 3X/WK n=10 Participants
Median Percent Change From Baseline in Compliment C3 at Week 24	25.8 Percentage Interval 13.6 to 55.4	3.6 Percentage Interval -25.7 to 33.3

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes only patients with low C4 (\<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=6 Participants	Belimumab SC 3X/WK n=11 Participants
Absolute Change From Baseline in Complement C4 at Week 24	7.2 mg/dL Standard Error 1.7	2.3 mg/dL Standard Error 1.4

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes only patients with low C4 (\<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=6 Participants	Belimumab SC 3X/WK n=11 Participants
Median Percent Change From Baseline in Complement C4 at Week 24	76.9 Percentage Interval 0.0 to 133.3	40.0 Percentage Interval -46.7 to 200.0

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=11 Participants	Belimumab SC 3X/WK n=14 Participants
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24	-33.1 IU/mL Standard Error 11.1	-6.0 IU/mL Standard Error 12.2

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=11 Participants	Belimumab SC 3X/WK n=14 Participants
Median Percent Change From Baseline in Anti-dsDNA at Week 24	-24.0 Percentage Interval -51.4 to 18.4	0.0 Percentage Interval -57.2 to 125.8

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24	0.1 mmol/L Standard Error 0.04	0.0 mmol/L Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline, 24 week

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Median Percent Change From Baseline in HDL at Week 24	4.8 Percentage Interval -16.1 to 34.6	2.2 Percentage Interval -38.2 to 72.7

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Absolute Change From Baseline in Total Cholesterol at Week 24	0.1 mmol/L Standard Error 0.09	0.0 mmol/L Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Median Percent Change From Baseline in Total Cholesterol at Week 24	1.0 Percentage Interval -17.2 to 20.9	1.6 Percentage Interval -36.3 to 45.7

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Median Percent Change From Baseline in Triglycerides at Week 24	-4.9 Percentage Interval -46.9 to 183.0	4.5 Percentage Interval -59.4 to 120.6

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: Analysis population includes all patients with both a baseline and Week 24 laboratory sample.

Outcome measures

Outcome measures
Measure	Belimumab SC Q2WKS n=25 Participants	Belimumab SC 3X/WK n=24 Participants
Absolute Change From Baseline in Triglycerides at Week 24	-0.1 mmol/L Standard Error 0.14	-0.0 mmol/L Standard Error 0.15

Adverse Events

Belimumab SC Q2WKS

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Belimumab SC 3X/WK

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Belimumab SC Q2WKS n=28 participants at risk 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.	Belimumab SC 3X/WK n=28 participants at risk 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.
Cardiac disorders Acute myocardial infarction	3.6% 1/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Cardiac disorders Bradycardia	0.00% 0/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Gastrointestinal disorders Retroperitoneal haemorrhage	3.6% 1/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Infections and infestations Cellulitis	0.00% 0/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Infections and infestations Gastroenteritis	0.00% 0/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Infections and infestations Pneumococcal sepsis	0.00% 0/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Infections and infestations Pyelonephritis	3.6% 1/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Infections and infestations Subcutaneous abscess	0.00% 0/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks

Other adverse events

Other adverse events
Measure	Belimumab SC Q2WKS n=28 participants at risk 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.	Belimumab SC 3X/WK n=28 participants at risk 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.
Gastrointestinal disorders Diarrhoea	14.3% 4/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Gastrointestinal disorders Mouth ulceration	3.6% 1/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Gastrointestinal disorders Nausea	7.1% 2/28 • Up to 24 Weeks	10.7% 3/28 • Up to 24 Weeks
General disorders Fatigue	10.7% 3/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
General disorders Injection site irritation	7.1% 2/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
General disorders Non-cardiac chest pain	0.00% 0/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
General disorders Pyrexia	3.6% 1/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Infections and infestations Gastroenteritis	7.1% 2/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Infections and infestations Herpes zoster	3.6% 1/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Infections and infestations Nasopharyngitis	17.9% 5/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Infections and infestations Sinusitis	0.00% 0/28 • Up to 24 Weeks	10.7% 3/28 • Up to 24 Weeks
Infections and infestations Upper respiratory tract infection	17.9% 5/28 • Up to 24 Weeks	10.7% 3/28 • Up to 24 Weeks
Infections and infestations Urinary tract infection	3.6% 1/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 3/28 • Up to 24 Weeks	14.3% 4/28 • Up to 24 Weeks
Musculoskeletal and connective tissue disorders Arthritis	3.6% 1/28 • Up to 24 Weeks	10.7% 3/28 • Up to 24 Weeks
Musculoskeletal and connective tissue disorders Myalgia	10.7% 3/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Musculoskeletal and connective tissue disorders SLE arthritis	7.1% 2/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Nervous system disorders Dizziness	10.7% 3/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks
Nervous system disorders Headache	21.4% 6/28 • Up to 24 Weeks	17.9% 5/28 • Up to 24 Weeks
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Respiratory, thoracic and mediastinal disorders Pleuritic pain	7.1% 2/28 • Up to 24 Weeks	0.00% 0/28 • Up to 24 Weeks
Skin and subcutaneous tissue disorders Rash	0.00% 0/28 • Up to 24 Weeks	7.1% 2/28 • Up to 24 Weeks
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	7.1% 2/28 • Up to 24 Weeks	3.6% 1/28 • Up to 24 Weeks

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER