SABLE: Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01729455

Collaborator

(none)

3,138

Enrollment

174

Locations

143.9

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Biological: BENLYSTA Other: SLE treatment

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

3138 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

Actual Study Start Date :

Feb 21, 2013

Anticipated Primary Completion Date :

Feb 17, 2025

Anticipated Study Completion Date :

Feb 17, 2025

Arms and Interventions

Arm	Intervention/Treatment
BENLYSTA cohort Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.	Biological: BENLYSTA As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus. Other Names: belimumab Other: SLE treatment As prescribed. At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.
Comparison cohort Participants with active, autoantibody-positive SLE treated without BENLYSTA at Baseline.	Other: SLE treatment As prescribed. At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Arm

Intervention/Treatment

BENLYSTA cohort

Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.

Biological: BENLYSTA

As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

Other Names:

belimumab

Other: SLE treatment

As prescribed. At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Comparison cohort

Participants with active, autoantibody-positive SLE treated without BENLYSTA at Baseline.

Other: SLE treatment

Outcome Measures

Primary Outcome Measures

Number of participants with AESI [Up to 5 years]
AESI including malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers (NMSC), mortality, serious infections, opportunistic infections and other infections of interest, and selected serious psychiatric events will be summarized.

Other Outcome Measures

Number of participants with organ damage [Up to 5 years]
Organ damage will be assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI). It is designed to capture items of irreversible organ damage present for at least 6 months occurring in participants with SLE regardless of exact cause. It consists of 12 organ system scales each having subscales which comprises of up to 6 components.
Number of participants with use of concomitant SLE medications [Up to 5 years]
Concomitant SLE medications including steroids are the medications used to treat SLE (immunosuppressants, anti-malarials, corticosteroids, biologics, and investigational agents for SLE).
Number of participants with hospitalizations [Up to 5 years]
An inpatient hospitalization is defined as an admission for greater than 24 hours. An admission for administration of medication or for routine or planned clinical procedures will not be considered a hospitalization. Dates of hospital admission and discharge, and whether the hospitalization was SLE-related will be collected, as available.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females age 18 years or older.
Have a clinical diagnosis of active SLE.
Current or history of autoantibody-positive SLE.
Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.

Exclusion Criteria:

Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used.
Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.
Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
Participants only receiving an anti-malarial for SLE.
Participants only receiving steroids for SLE.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35294
2	GSK Investigational Site	Glendale	Arizona	United States	85304
3	GSK Investigational Site	Goodyear	Arizona	United States	85395
4	GSK Investigational Site	Phoenix	Arizona	United States	85032
5	GSK Investigational Site	Phoenix	Arizona	United States	85037
6	GSK Investigational Site	Tucson	Arizona	United States	85704
7	GSK Investigational Site	Tucson	Arizona	United States	85712
8	GSK Investigational Site	Bakersfield	California	United States	93301
9	GSK Investigational Site	Glendale	California	United States	91204
10	GSK Investigational Site	La Mesa	California	United States	92020
11	GSK Investigational Site	Lakewood	California	United States	90712
12	GSK Investigational Site	Loma Linda	California	United States	92354
13	GSK Investigational Site	Los Angeles	California	United States	90033
14	GSK Investigational Site	Los Angeles	California	United States	90048
15	GSK Investigational Site	Los Angeles	California	United States	90095
16	GSK Investigational Site	Murrieta	California	United States	92563
17	GSK Investigational Site	Pomona	California	United States	91767
18	GSK Investigational Site	Upland	California	United States	91786
19	GSK Investigational Site	West Hills	California	United States	91307
20	GSK Investigational Site	Danbury	Connecticut	United States	06810
21	GSK Investigational Site	Hamden	Connecticut	United States	06518
22	GSK Investigational Site	New Haven	Connecticut	United States	06520
23	GSK Investigational Site	Clearwater	Florida	United States	33759
24	GSK Investigational Site	Fort Lauderdale	Florida	United States	33309
25	GSK Investigational Site	Juniper	Florida	United States	33458
26	GSK Investigational Site	Largo	Florida	United States	33770
27	GSK Investigational Site	Miami	Florida	United States	33126
28	GSK Investigational Site	Miami	Florida	United States	33136
29	GSK Investigational Site	Palm Harbor	Florida	United States	34684
30	GSK Investigational Site	Pembroke Pines	Florida	United States	33026
31	GSK Investigational Site	Pensacola	Florida	United States	32514
32	GSK Investigational Site	Plantation	Florida	United States	33324
33	GSK Investigational Site	Atlanta	Georgia	United States	30303
34	GSK Investigational Site	Gainesville	Georgia	United States	30501
35	GSK Investigational Site	Meridian	Idaho	United States	83642
36	GSK Investigational Site	Chicago	Illinois	United States	60611
37	GSK Investigational Site	Chicago	Illinois	United States	60612
38	GSK Investigational Site	Morton Grove	Illinois	United States	60053
39	GSK Investigational Site	South Bend	Indiana	United States	46601
40	GSK Investigational Site	Baton Rouge	Louisiana	United States	70719
41	GSK Investigational Site	Shreveport	Louisiana	United States	71103
42	GSK Investigational Site	Baltimore	Maryland	United States	21286
43	GSK Investigational Site	Springfield	Massachusetts	United States	01107
44	GSK Investigational Site	Ann Arbor	Michigan	United States	48109-5542
45	GSK Investigational Site	Detroit	Michigan	United States	48202
46	GSK Investigational Site	Lansing	Michigan	United States	48917
47	GSK Investigational Site	Eagan	Minnesota	United States	55121
48	GSK Investigational Site	Edina	Minnesota	United States	55435
49	GSK Investigational Site	Jackson	Mississippi	United States	39216
50	GSK Investigational Site	Tupelo	Mississippi	United States	38801
51	GSK Investigational Site	Saint Louis	Missouri	United States	63110
52	GSK Investigational Site	Saint Louis	Missouri	United States	63117
53	GSK Investigational Site	Saint Louis	Missouri	United States	63132
54	GSK Investigational Site	Omaha	Nebraska	United States	68198-3025
55	GSK Investigational Site	Henderson	Nevada	United States	89052
56	GSK Investigational Site	Camden	New Jersey	United States	08103
57	GSK Investigational Site	New Brunswick	New Jersey	United States	08901
58	GSK Investigational Site	Summit	New Jersey	United States	07901
59	GSK Investigational Site	Teaneck	New Jersey	United States	07666
60	GSK Investigational Site	Bronx	New York	United States	10461
61	GSK Investigational Site	Manhasset	New York	United States	11030
62	GSK Investigational Site	Mineola	New York	United States	11501
63	GSK Investigational Site	New York	New York	United States	10016
64	GSK Investigational Site	New York	New York	United States	10021
65	GSK Investigational Site	Roslyn	New York	United States	11576
66	GSK Investigational Site	Smithtown	New York	United States	11787
67	GSK Investigational Site	Charlotte	North Carolina	United States	28204
68	GSK Investigational Site	Charlotte	North Carolina	United States	28207
69	GSK Investigational Site	Durham	North Carolina	United States	27713
70	GSK Investigational Site	Greensboro	North Carolina	United States	27405
71	GSK Investigational Site	New Bern	North Carolina	United States	28562
72	GSK Investigational Site	Raleigh	North Carolina	United States	27617
73	GSK Investigational Site	Rocky Mount	North Carolina	United States	27804
74	GSK Investigational Site	Winston-Salem	North Carolina	United States	27157
75	GSK Investigational Site	Columbus	Ohio	United States	43203
76	GSK Investigational Site	Toledo	Ohio	United States	43614
77	GSK Investigational Site	Edmond	Oklahoma	United States	73013
78	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73103
79	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73104
80	GSK Investigational Site	Tulsa	Oklahoma	United States	74104
81	GSK Investigational Site	Duncansville	Pennsylvania	United States	16635
82	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15224
83	GSK Investigational Site	Charleston	South Carolina	United States	29406
84	GSK Investigational Site	Charleston	South Carolina	United States	29425
85	GSK Investigational Site	Hixson	Tennessee	United States	37343-7908
86	GSK Investigational Site	Nashville	Tennessee	United States	37203
87	GSK Investigational Site	Allen	Texas	United States	75013
88	GSK Investigational Site	Houston	Texas	United States	77004
89	GSK Investigational Site	Houston	Texas	United States	77034
90	GSK Investigational Site	Nassau Bay	Texas	United States	77058
91	GSK Investigational Site	Round Rock	Texas	United States	78665
92	GSK Investigational Site	San Marcos	Texas	United States	78666
93	GSK Investigational Site	Arlington	Virginia	United States	22205-3606
94	GSK Investigational Site	Danville	Virginia	United States	24541
95	GSK Investigational Site	Norfolk	Virginia	United States	23502
96	GSK Investigational Site	Roanoke	Virginia	United States	24016
97	GSK Investigational Site	Seattle	Washington	United States	98133
98	GSK Investigational Site	Manitowoc	Wisconsin	United States	54221-1450
99	GSK Investigational Site	Parana	Entre Ríos	Argentina	3103
100	GSK Investigational Site	Buenos Aires		Argentina	C1280AEB
101	GSK Investigational Site	Ciudad Autonoma Buenos Aires		Argentina	C1426AAL
102	GSK Investigational Site	Graz		Austria	8036
103	GSK Investigational Site	Linz		Austria	4021
104	GSK Investigational Site	Salzburg		Austria	A-5020
105	GSK Investigational Site	Vienna		Austria	A-1100
106	GSK Investigational Site	Leuven		Belgium	3000
107	GSK Investigational Site	Mississauga	Ontario	Canada	L5M 2V8
108	GSK Investigational Site	Toronto	Ontario	Canada	M5T 2S8
109	GSK Investigational Site	Montreal	Quebec	Canada	H3G 1A4
110	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1G 2E8
111	GSK Investigational Site	Quebec		Canada	G1V 2L9
112	GSK Investigational Site	Bondy		France	93140
113	GSK Investigational Site	Lille cedex		France	59037
114	GSK Investigational Site	Parris Cedex 12		France	75571
115	GSK Investigational Site	Strasbourg Cedex		France	67098
116	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg	Germany	69121
117	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg	Germany	70376
118	GSK Investigational Site	Bad Nauheim	Hessen	Germany	61231
119	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen	Germany	40225
120	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
121	GSK Investigational Site	Halle	Sachsen-Anhalt	Germany	06120
122	GSK Investigational Site	Dresden	Sachsen	Germany	01067
123	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein	Germany	24576
124	GSK Investigational Site	Kiel	Schleswig-Holstein	Germany	24105
125	GSK Investigational Site	Luebeck	Schleswig-Holstein	Germany	23538
126	GSK Investigational Site	Jena	Thueringen	Germany	07740
127	GSK Investigational Site	Elmshorn		Germany	25335
128	GSK Investigational Site	Hamburg		Germany	22767
129	GSK Investigational Site	Koeln		Germany	51149
130	GSK Investigational Site	Leipzig		Germany	04129
131	GSK Investigational Site	Puettlingen		Germany	66346
132	GSK Investigational Site	Ashkelon		Israel	78278
133	GSK Investigational Site	Haifa		Israel	31048
134	GSK Investigational Site	Haifa		Israel	31096
135	GSK Investigational Site	Jerusalem		Israel	91120
136	GSK Investigational Site	Petach Tikva		Israel	49100
137	GSK Investigational Site	Ramat-Gan		Israel	52621
138	GSK Investigational Site	Rehovot		Israel	76100
139	GSK Investigational Site	Tel-Aviv		Israel	64239
140	GSK Investigational Site	Roma	Lazio	Italy	00161
141	GSK Investigational Site	Roma	Lazio	Italy	00168
142	GSK Investigational Site	Milano	Lombardia	Italy	20122
143	GSK Investigational Site	Milano	Lombardia	Italy	20132
144	GSK Investigational Site	Milano	Lombardia	Italy	20157
145	GSK Investigational Site	Pisa	Toscana	Italy	56126
146	GSK Investigational Site	Padova	Veneto	Italy	35128
147	GSK Investigational Site	Brescia		Italy	25125
148	GSK Investigational Site	Siena		Italy	53100
149	GSK Investigational Site	Udine		Italy	33100
150	GSK Investigational Site	Lisboa		Portugal	1069-166
151	GSK Investigational Site	Banksa Bystrica		Slovakia	97401
152	GSK Investigational Site	Bratislava		Slovakia	826 06
153	GSK Investigational Site	Kosice		Slovakia	040 11
154	GSK Investigational Site	Piestany		Slovakia	921 01
155	GSK Investigational Site	A Coruna		Spain	15006
156	GSK Investigational Site	Alicante		Spain	03010
157	GSK Investigational Site	Barakaldo		Spain	48903
158	GSK Investigational Site	Barcelona		Spain	08035
159	GSK Investigational Site	Barcelona		Spain	08907
160	GSK Investigational Site	Getafe		Spain	28905
161	GSK Investigational Site	Las Palmas GC		Spain	35020
162	GSK Investigational Site	Madrid		Spain	28007
163	GSK Investigational Site	Madrid		Spain	28041
164	GSK Investigational Site	Majadahonda		Spain	28222
165	GSK Investigational Site	Murica		Spain	30120
166	GSK Investigational Site	Santander		Spain	39008
167	GSK Investigational Site	Sevilla		Spain	41010
168	GSK Investigational Site	Toledo		Spain	45111
169	GSK Investigational Site	Valencia		Spain	46017
170	GSK Investigational Site	Valencia		Spain	46026
171	GSK Investigational Site	Valladolid		Spain	47012
172	GSK Investigational Site	Vigo/ Pontevedra		Spain	36200
173	GSK Investigational Site	Vilajoyosa		Spain	3570
174	GSK Investigational Site	Stockholm		Sweden	SE-171 76