A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00424476

First received: January 17, 2007

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Results First Received: April 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Systemic Lupus Erythematosus
Interventions:	Drug: Placebo Drug: Belimumab 1 mg/kg Drug: Belimumab 10 mg/kg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.

Participant Flow: Overall Study

	Placebo	Belimumab 1 mg/kg	Belimumab 10 mg/kg
STARTED	287	288	290
COMPLETED	226	240	241
NOT COMPLETED	61	48	49
Withdrawal by Subject	7	6	3
Adverse Event	19	16	15
Lack of Efficacy	16	12	12
Lack of Compliance	1	1	1
Lost to Follow-up	4	6	3
Protocol Violation	7	2	3
Physician Decision	3	2	3
Other	4	3	9

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Belimumab 1 mg/kg	Belimumab 10 mg/kg	Total
Number of Participants [units: participants]	287	288	290	865
Age [units: years] Mean ± Standard Deviation	36.2 ± 11.8	35.0 ± 10.6	35.4 ± 10.8	35.5 ± 11.1
Age, Customized [units: participants]
≤ 45 years	225	236	236	697
Between 45 and 65 years	57	48	52	157
≥ 65 years	5	4	2	11
Gender [units: participants]
Female	270	271	280	821
Male	17	17	10	44
Region of Enrollment [units: participants]
Europe	33	34	31	98
South America	145	143	140	428
Southeast Asia	103	106	115	324
Australia	6	5	4	15

Outcome Measures

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1. Primary:

SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Baseline, 52 weeks ]

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2. Secondary:

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. [ Time Frame: Baseline, 52 weeks ]

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3. Secondary:

Mean Change in Physician's Global Assessment (PGA) at Wk 24. [ Time Frame: Baseline, 24 weeks ]

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4. Secondary:

Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. [ Time Frame: Baseline, 24 weeks ]

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5. Secondary:

Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 [ Time Frame: Baseline, Weeks 40 through 52 ]

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6. Other Pre-specified:

Adverse Events (AE) Overview [ Time Frame: Up to 56 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 at 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.

van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. Epub 2012 Feb 15.

Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.

Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. Epub 2011 Feb 4.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00424476 History of Changes
Other Study ID Numbers:	110752, BLISS-52, HGS1006-C1057
Study First Received:	January 17, 2007
Results First Received:	April 7, 2011
Last Updated:	December 10, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Therapeutic Goods Administration Brazil: National Health Surveillance Agency Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Hong Kong: Department of Health India: Drugs Controller General of India Korea: Food and Drug Administration Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Romania: Ministry of Public Health Russia: Ministry of Health of the Russian Federation Taiwan: Department of Health United States: Food and Drug Administration

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