DDrare: Database of Drug Development for Rare Diseases

49. 全身性エリテマトーデス
［臨床試験数：827，薬物数：638（DrugBank：168），標的遺伝子数：108，標的パスウェイ数：191］

Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.15mg KPG-818 dose; 0.6mg KPG-818 dose; 1 mg/kg CNTO 136; 10 mg/kg CNTO 136; 2-deoxy-2 [F-18] fluoro-2-d-glucose; 2mg KPG-818 dose; 4 mg/kg CNTO 136; 81mg aspirin; A-623; ABATACEPT; ABBV-105; ABETIMUS SODIUM; ABR-215757; ABT-199; ABT-494; AC0058TA; ACM; ACT-334441; AGS-009; AIDSVAX® B/E; AKBM-3031; ALDESLEUCHINA; ALDESLEUKIN; ALITRETINOIN; ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD; ALX-0061; ALX-0061 150 mg/mL; AMG 557; AMG 570; AMG 592; AMG 623; AMG 811; AMG592; AMG811; ANAKINRA; ANIFROLUMAB; ASF-1096 Cream 0.25%; ASF-1096 Cream 0.5%; ASF-1096 Cream 1.0%; ATACICEPT; Abatacept; Abetimus; Abetimus Sodium; Abetimus sodium; Abetimus sodium (LJP 394); Acetaminophen; Acetate; Acetylcysteine; Acido Micofenolico; Acido micofenolico; Acthar; Acthar Gel; Acthar high dose (80 U); Acthar low dose (40 U); Aldesleukin; Alfacalcidol; Alitretinoin; Allogeneic MSC (AlloMSC); Allogeneic Stem Cell Transplantation; Allogeneic bone marrow transplant; Alpha-tocopherol; Anakinra; Anifrolumab; Anifrolumab 1000 mg; Anifrolumab 300 mg; Anti BAFF (B cell activating factor); Anti LP40 antibody, subclass IgG4; Anti LP40 anticuerpo, subclase IgG4; Anti-CD19-CAR-T cells; Anti-CD20 B cell depletion with Truxima; Anti-CD28dAb; Anti-CD28dab; Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody; Anti-blood dendritic cell antigen 2; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Aspirin; Aspirin and meloxicam; Atacicept; Atacicept 150 mg; Atacicept 75 mg; Atacicept 75 milligram (mg); Atorvastatin; Autologous EBV specific CTL infusion; Aviptadil; Azathioprine; BARICITINIB; BELIMUMAB; BENLYSTA; BENLYSTA? (belimumab); BENLYSTA™ (belimumab); BI 705564; BIIB059; BMS-188667; BMS-931699; BMS-986165; BMS-986165 Capsule; BMS-986165 Tablet; BMS-986195; BMS986195; BORTEZOMIB; BOS161721; BR-DIM; BT063; Baricitinib; Behavioral: heart health educational program; Behavioral: questionnaires; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 10 mg/kg plus standard therapy; Belimumab 100 mg SC; Belimumab 10mg/kg; Belimumab 200 mg SC; Belimumab 200 mg/mL; Belimumab 4 mg/kg; Belimumab Injection; Belimumab Injection [Benlysta]; Belimumab for IV; Belimumab for SC; Belimumab or benlysta; Belimumab plus Early Vaccination; Belimumab plus Late Vaccination; Benazepril; Benazepril Pill; Benlysta; Benlysta (Belimumab); Benlysta (belimumab); Benlysta 400 mg powder for concentrate for solution for infusion; Benlysta 400 mg powder for concentrate for solution for infusions; Benlysta®; Blisibimod; Blood sample; Bortezomib; Branebrutinib; Brentuximab; Brentuximab vedotin; Busulfan; CC; CC-220; CDP3194; CDP7657; CEP-33457; CFZ533; CICLOSPORIN; CICLOSPORINA; CNTO1275; CSM allogéniques issues de cordons ombilicaux ( MTI-PP); CTLA4-IgG4m (RG2077); CTLA4Ig; Calcitriol; Calcium; Campath; CellCept; Cellcept; Cenerimod; Cenerimod 0.5 mg; Cenerimod 1 mg; Cenerimod 2 mg; Cenerimod 4 mg; Cervarix; Cervarix suspensie voor injectie; Chloroquine; Cholecalciferol; Cholecalciferol and C. Xanthorrhiza; Ciclosporin; Ciclosporina; Clofarabine; Clopidogrel; Combination Product: Belimumab; Conjugated equine estrogens; Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d; Continuation of azathioprine; Corn starch; Corticosteroids; Corticosteroids (prednisone or prednisolone); Creatine; Crestor; Csa; Cumulative corticosteroid exposure; Curcumin; Curcumin supplement; Cyclophosphamide; Cyclophosphamide-prednisone-azathioprine; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cymbalta; Cytarabine; D-glucose; DELTACORTENE*20CPR 5MG; DHA; DHEA; DZP; Dapagliflozin; Dapirolizumab pegol; Dapirolizumab pegol (DZP); Dehydroepiandrosterone; Dehydroepiandrosterone (DHEA); Device: Belimumab autoinjector; Device: Doppler ultrasound; Device: Flash glucose monitoring system; Device: bone densitometry; Device: fan beam CT scan; Device: flow-mediated dilation of the brachial artery; Dihydroartemisinin; Dihydroartemisinin tablet; Dimethylfumarat; Diphenhydramine; Dipyridamole; Docosahexaenoic acid; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; ELSUBRUTINIB; EPA; EPA and DHA supplementation; EPRATUZUMAB; ERL080A; Edratide; Edratide Acetate; Eicosapentaenoic acid; Elsubrutinib; Enteric-Coated Mycophenolate Sodium; Epatuzumab; Epratuzumab; Epratuzumab 100 mg; Epratuzumab 1200 mg; Epratuzumab 400 mg; Epratuzumab 600 mg; Epratuzumab iv; Epratuzumab sc; Estradiol; Ethinyl estradiol; Ethylhydrogenfumarat, Calciumsalz; Ethylhydrogenfumarat, Magnesiumsalz; Ethylhydrogenfumarat, Zinksalz; Evobrutinib; Extended release dipyridamole 200mg/aspirin 25mg; Ezetimibe; Ezetimibe+Simvastatin Drug Combination; Faslodex; Filgrastim; Fish Oil; Fish oil; Fludarabine; Fludarabine phosphate; Fluzone; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic acid; Forigerimod; Fostamatinib; Fostamatinib Disodium (R935788); Fumaderm®; Fumaderm® initial; G-CSF; GC+HCQ; GDC-0853; GDC-0853 RO7010939; GL701; GSK1550188; GSK1550188 1mg/kg or 10mg/kg; GSK1550188 IV; GSK1550188 SC; GSK2586184; GSK2586184 100 mg; GSK2586184 200 mg; GSK2586184 400 mg; GSK2586184 50 mg; GSK2586184 800mg single and repeat dose; GSK2586184 new formulation; GSK2586184 standard formulation; Gardasil; Genetic: Polymorphism Analysis; Glucose; Gold; Group A SLE prospective study; Growth colony stimulating factor (G-CSF); H.P. Acthar Gel; HCQ; HGS1006; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HLL2; HLL2 (Epratuzumab); HLL2 (trivial name or chemical description); HLL2,IMMU-103; HPV prophylactic vaccine Gardasil; HYDROXYCHLOROQUINE; Hematopoietic stem cell transplantation; High Dietary Sodium; High Dose Mesenchymal Stem Cells (MSCs); Hiomega-3 supplement of Naturalis® company -; HrIL-2 active; Human papillomavirus vaccination (Gardasil); Human umbilical cord derived MSC transplantation for SLE; Hydroxychloroquine; Hydroxychloroquine (Z0188); Hydroxychloroquine high; Hydroxychloroquine or Chloroquine; Hydroxychloroquine reduced; ICI 182,780 (Faslodex); ICP-022; IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFN-a 2b Kinoid Drug Substance; IFN-a2b Kinoid; IFNa-Kinoid; IL-2; IL-6R nanobody; ILT-101; IMMU-103; IMMUNOGLOBULIN G; INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED); INTERLEUKIN 2; INTERLEUKIN-2; IPP - 201101; IPP-201101; IPP-201101, P140; Ianalumab; Ibandronate; Ibandronate+alfacalcidol+calcium; Immune ablation and hematopoietic stem cell support.; Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer; Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate); Individualized dose of rituximab; Infliximab; Influenz virus surface antigens; Influvac; Interleukin 2; Interleukin-2; Intravenous immunoglobulin; Iscalimab; Itolizumab; Itolizumab [Bmab 600]; JBT-101; JNJ-55920839; JNJ-56022473; KINERET; KPG-818; KZR-616; Kineret; L04AA26; LA294; LJP 394; LJP394; LY2127399; LY3009104; LY3361237; LY3471851; Laquinimod; Leflunomide; Lenalidomide; Levothyroxine; Lisinopril; Lisinopril Pills; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Low Dietary Sodium; Low Dose Mesenchymal Stem Cells (MSCs); Low-dose Aldesleukin (Proleukin®); Lulizumab Pegol; Lulizumab pegol; Lupuzor; LymphoStat-B; LymphoStat-B TM; LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®; M2951; M2951 (Other Name: Evobrutinib); M5049; MEDI 545; MEDI-545; MEDI-545 600; MEDI-546; MEDI-570 0.03 MG; MEDI-570 0.1 MG; MEDI-570 0.3 MG; MEDI-570 1 MG; MICOFENOLICO ACIDO; MMF; MONITOR; MPA; MRA 003 US; MSC treatment; MSC2364447C; MT-1303 High dose; MT-1303 Low dose; MTX; MYCOPHENOLIC ACID; MYFORTIC*50CPR RIV 360MG; MabThera; MabThera (Rituximab); Medi-546; Medroxyprogesterone; Melatonin; Meloxicam; Memantine; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesna; Metformin; Methotrexate; Methotrexate and folic acid; Methyl prednisolone; Methylprednisolone; Methylprednisolone sodium succinate; Micofenolico acido; Milatuzumab; Milnacipran; Mizoribine; Modafinil; Moxifloxacin; Multivitamin; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (MMF); Mycophenolate motetil; Mycophenolic acid; Myfortic; N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide; N-acetylcysteine; NNC 0151-0000-0000; NNC0114-0006; NOX-E36; Nelfinavir; Nicotinamide; Nivolumab; Norethindrone; Normal Saline; Null; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; Ocrelizumab; Olive; Olive Oil; Olive oil; Olumiant; Omacor; Omega-3; Oral Prednisone 5mg; Oral prednisolone; Orencia; Ortho-Novum 777; Ortho-novum; Other: Blood drawing only Group C; Other: Coaching Sessions; Other: Concomitant Medication; Other: Drug free; Other: Fitbit Activity Monitor; Other: GSK2586184 single dose taken with food; Other: GSK2586184 single dose taken without food; Other: Group B SLE one blood donation; Other: ISA 51 VG; Other: Pharmacokinetic analysis; Other: SLE treatment; Other: Smartphone Application; Other: Standard of Care; Other: Standard therapy; Other: Standard treatment according to the Clinical protocols; Other: Ultrasonography assessment; Other: corn starch; Other: immunologic technique; Other: laboratory biomarker analysis; Oxygen; Ozone; P 140; PAH; PF-04236921; PF-06700841; PF-06700841 15 mg; PF-06700841 25mg; PF-06700841 30 mg; PF-06700841 45 mg; PF-06700841 5mg; PF-06700841-15; PF-06835375; PREDNISONA; PREDNISONE; Paquinimod; Paquinimod (ABR-215757); Phosphate; Phosphate-buffered saline; Pioglitazone; Pitavastatin; Placebo; Plaquenil; Pneumovax; Pooled mesenchymal stem cell; Prasterone; Prasterone (GL701); Pravastatin; Prednisolone; Prednisolone/prednisone; Prednisona; Prednisone; Prednisone acetate; Prednisone discontinuation; Premarin and Provera; Prevenar® and Pneumo23®; Procedure: Autologous CD34+HPC transplantation (HSCT); Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion; Procedure: Computed Tomography; Procedure: Leukapheresis; Procedure: MRI, Venipuncture; Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT); Procedure: Plasmapheresis; Procedure: Positron Emission Tomography; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: autologous hematopoietic stem cell transplantation; Proleukin; Quinipril; R-salbutamol; R-salbutamol sulphate; R932333; RANKL/OPG ratio; RAYOS; RC18 160 mg plus standard therapy; RC18 240 mg plus standard therapy; RC18 80 mg plus standard therapy; RECOMBINANT FACTOR FC FUSION PROTEIN; RIQUENT; RITUXIMAB; RO 496-4913; RO7010939/F13; ROSUVASTATIN CALCIUM; RSLV-132; Rabbit; Rabbit anti-thymocyte globulin; Rabbit antithymocyte globulin; Radiation: Fluorine F 18 Clofarabine; Radiation: Total body irradiation; Ramipril; Rapamycin; Raptiva; Recombinant zoster vaccine; Remicade; RhuMAb 2H7; RhuMAb IFNalpha; Rigerimod; Riquent; Rituxan (rituximab); Rituximab; Rivaroxaban; Ro 106-1443; Rontalizumab; Rosuvastatin; Royal jelly; SAR113244; SBI-087; SC belimumab 200 mg; SM101; SM934; SOLU-MEDROL; SQ Fludarabine; STELARA®; Salbutamol; Sifalimumab; Sifalimumab 1,200 mg; Sifalimumab 200 mg; Sifalimumab 600 mg; Simvastatin; Sirolimus; Solu-Medrol; Solu-medrol; Soluble Fc receptor; Soluble Fc-gamma receptor IIb; Standard dose of rituximab; Standard of Care; Standard therapy; Standard therapy (Excluding Immunosuppressants); Standard therapy (Including Immunosuppressants); Stelara; Steroid Drug; Steroid Taper; Subcuvia; Sugar pill; Sulfamethoxazole; Sulfate; Switch to Myfortic; TAB08; TACI-Fc5; TAK-079; TRU-015; TV-4710; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Thalidomide; The generic name is warfarin and many producers will be involved; Tocopherol; Tocopherol acetate; Toctino; Toctino®; Tofacitinib; Tofacitinib citrate; Trade Name Xarelto; Trade name Xarelto; Trimethoprim; Trimethoprim-Sulfamethoxazole; Triptorelin; Triptorelin pamoate; Truxima; UPADACITINIB; USTEKINUMAB; Upadacitinib; Urine sample; Ustekinumab; Ustekinumab (approximately 6 mg/kg); Ustekinumab 90 mg; Ustekinumab 90 milligram (mg); Ustekinumab IV; Ustekinumab SC; VAY736; VIB7734; VIP; Vaccination; Vaccine; Velcade; Velcade®; Versus hydroxychloroquine; Vitamin D; Vitamin D 25(OH)D; Vitamin D3; Vitamin D3 400 IU; Vitamin D3 6000 IU; Vitamins: B6, B12, and folate; Vobarilizumab; Warfarin; Warfarin Sodium; Warfarin sodium; Xarelto; XmAb5871; Zishenqing; Zostavax; Zostavax vaccine

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-003050-32-ES (EUCTR)	05/12/2017	01/12/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
2	EUCTR2011-005672-42-GB (EUCTR)	11/06/2013	27/03/2013	Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)	A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE	Systemic Lupus Erythematosus (SLE) MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3;Phase 4	United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom
3	NCT01632241 (ClinicalTrials.gov)	February 19, 2013	28/6/2012	Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)	A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	503	Phase 4	United States;Brazil;Colombia;France;South Africa;United Kingdom
4	NCT01597622 (ClinicalTrials.gov)	June 11, 2012	10/5/2012	BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115	BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan	Systemic Lupus Erythematosus	Drug: Belimumab	GlaxoSmithKline	Human Genome Sciences Inc.	Completed	18 Years	N/A	All	142	Phase 3	Japan;Korea, Republic of
5	EUCTR2011-003814-18-PL (EUCTR)	06/06/2012	19/06/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2011-003814-18-PT (EUCTR)	01/06/2012	21/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
7	NCT01597492 (ClinicalTrials.gov)	May 31, 2012	8/5/2012	A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Biological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late Vaccination	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	79	Phase 4	United States
8	EUCTR2011-003814-18-BE (EUCTR)	29/05/2012	01/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
9	EUCTR2011-003814-18-BG (EUCTR)	22/05/2012	21/05/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
10	EUCTR2011-003814-18-IT (EUCTR)	15/05/2012	08/06/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab Product Code: NA INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	HUMAN GENOME SCIENCES INC	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2011-003814-18-DE (EUCTR)	03/05/2012	16/12/2011	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
12	EUCTR2011-003814-18-ES (EUCTR)	03/05/2012	29/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
13	EUCTR2011-003814-18-GB (EUCTR)	12/04/2012	19/04/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
14	EUCTR2011-003814-18-SE (EUCTR)	28/03/2012	31/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
15	EUCTR2011-003814-18-CZ (EUCTR)	27/03/2012	25/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2011-003814-18-HU (EUCTR)	08/03/2012	18/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
17	EUCTR2011-003814-18-DK (EUCTR)	08/03/2012	08/03/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
18	EUCTR2011-003814-18-AT (EUCTR)	01/02/2012	23/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
19	NCT01484496 (ClinicalTrials.gov)	November 16, 2011	28/11/2011	A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	839	Phase 3	United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
20	NCT01858792 (ClinicalTrials.gov)	May 2011	19/12/2012	A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies	Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies	Lupus Erythematosus, Discoid	Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	Both	1	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2007-007648-85-AT (EUCTR)	21/01/2010	09/12/2008	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
22	EUCTR2007-007648-85-FR (EUCTR)	08/09/2009	17/07/2009	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057	Systemic lupus erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus		Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
23	EUCTR2007-007648-85-SE (EUCTR)	26/08/2009	03/06/2009	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 1;Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
24	EUCTR2007-007648-85-SK (EUCTR)	28/07/2009	24/06/2009	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057	Systemic lupus erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term:	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
25	EUCTR2007-007648-85-BE (EUCTR)	01/07/2009	05/01/2009	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2007-007648-85-IT (EUCTR)	03/06/2009	20/04/2009	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND	Systemic lupus erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Belimumab Product Code: HGS1006 Product Name: Belimumab Product Code: HGS1006	HUMAN GENOME SCIENCES INC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden
27	EUCTR2007-007648-85-ES (EUCTR)	27/04/2009	25/02/2009	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057	Systemic lupus erythematosus (SLE)Lupus Eritematoso Sistémico (LES) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
28	EUCTR2007-007648-85-NL (EUCTR)	07/04/2009	19/12/2008	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusions Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B; Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Germany;Netherlands;Sweden;Korea, Republic of
29	EUCTR2007-007648-85-CZ (EUCTR)	01/04/2009	26/01/2009	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Benlysta ® Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
30	EUCTR2007-007648-85-GB (EUCTR)	13/03/2009	19/01/2009	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2007-007648-85-DE (EUCTR)	06/02/2009	03/12/2008	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of
32	NCT00732940 (ClinicalTrials.gov)	October 2008	8/8/2008	Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Belimumab 100 mg SC	Human Genome Sciences Inc.	GlaxoSmithKline	Terminated	18 Years	N/A	All	56	Phase 2	United States;Mexico
33	NCT00724867 (ClinicalTrials.gov)	August 2008	28/7/2008	A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States	Systemic Lupus Erythematosus	Biological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kg	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	268	Phase 3	United States;Canada
34	NCT00712933 (ClinicalTrials.gov)	May 30, 2008	8/7/2008	A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057	A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057	Systemic Lupus Erythematosus	Drug: belimumab	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	738	Phase 3	Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czechia;France;Germany;Hong Kong;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;United Kingdom;Australia;China;Costa Rica;Czech Republic
35	EUCTR2006-005177-21-AT (EUCTR)	06/12/2007	26/02/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2006-005177-21-IT (EUCTR)	20/09/2007	13/07/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056	Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Belimumab Product Code: HGS1006	HUMAN GENOME SCIENCES INC	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
37	EUCTR2006-005177-21-FR (EUCTR)	11/09/2007	23/07/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
38	EUCTR2006-005177-21-NL (EUCTR)	03/08/2007	04/06/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
39	EUCTR2006-005177-21-SE (EUCTR)	08/06/2007	07/05/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
40	EUCTR2006-005177-21-GB (EUCTR)	29/05/2007	02/01/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus		Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2006-005177-21-SK (EUCTR)	17/05/2007	20/03/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
42	EUCTR2006-005177-21-ES (EUCTR)	09/05/2007	09/03/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76	Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
43	EUCTR2006-005177-21-BE (EUCTR)	07/05/2007	29/01/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
44	EUCTR2006-005177-21-DE (EUCTR)	03/05/2007	20/02/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
45	NCT00424476 (ClinicalTrials.gov)	May 2007	17/1/2007	A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg	Human Genome Sciences Inc.	GlaxoSmithKline	Completed	18 Years	N/A	All	865	Phase 3	Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2006-005177-21-CZ (EUCTR)	23/04/2007	28/02/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
47	NCT00410384 (ClinicalTrials.gov)	December 2006	8/12/2006	A Study of Belimumab in Subjects With Systemic Lupus Erythematosus	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg	Human Genome Sciences Inc.	GlaxoSmithKline	Completed	18 Years	N/A	All	819	Phase 3	United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-003050-32-ES
(EUCTR)

05/12/2017

01/12/2017

A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA

GlaxoSmithKline, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of

EUCTR2011-005672-42-GB
(EUCTR)

11/06/2013

27/03/2013

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)

A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE

Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 3;Phase 4

United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom

NCT01632241
(ClinicalTrials.gov)

February 19, 2013

28/6/2012

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

503

Phase 4

United States;Brazil;Colombia;France;South Africa;United Kingdom

NCT01597622
(ClinicalTrials.gov)

June 11, 2012

10/5/2012

BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan

Systemic Lupus Erythematosus

Drug: Belimumab

GlaxoSmithKline

Human Genome Sciences Inc.

Completed

18 Years

N/A

All

142

Phase 3

Japan;Korea, Republic of

EUCTR2011-003814-18-PL
(EUCTR)

06/06/2012

19/06/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC

Systemic lupus erythematosis (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-003814-18-PT
(EUCTR)

01/06/2012

21/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

NCT01597492
(ClinicalTrials.gov)

May 31, 2012

8/5/2012

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Biological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late Vaccination

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

Phase 4

United States

EUCTR2011-003814-18-BE
(EUCTR)

29/05/2012

01/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

EUCTR2011-003814-18-BG
(EUCTR)

22/05/2012

21/05/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

EUCTR2011-003814-18-IT
(EUCTR)

15/05/2012

08/06/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
Product Code: NA
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

HUMAN GENOME SCIENCES INC

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-003814-18-DE
(EUCTR)

03/05/2012

16/12/2011

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

EUCTR2011-003814-18-ES
(EUCTR)

03/05/2012

29/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

EUCTR2011-003814-18-GB
(EUCTR)

12/04/2012

19/04/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

EUCTR2011-003814-18-SE
(EUCTR)

28/03/2012

31/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden

EUCTR2011-003814-18-CZ
(EUCTR)

27/03/2012

25/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-003814-18-HU
(EUCTR)

08/03/2012

18/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

EUCTR2011-003814-18-DK
(EUCTR)

08/03/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

EUCTR2011-003814-18-AT
(EUCTR)

01/02/2012

23/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

NCT01484496
(ClinicalTrials.gov)

November 16, 2011

28/11/2011

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

839

Phase 3

United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic

NCT01858792
(ClinicalTrials.gov)

May 2011

19/12/2012

A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Lupus Erythematosus, Discoid

Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-007648-85-AT
(EUCTR)

21/01/2010

09/12/2008

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA

Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of

EUCTR2007-007648-85-FR
(EUCTR)

08/09/2009

17/07/2009

Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2007-007648-85-SE
(EUCTR)

26/08/2009

03/06/2009

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 1;Phase 3

EUCTR2007-007648-85-SK
(EUCTR)

28/07/2009

24/06/2009

Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term:

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2007-007648-85-BE
(EUCTR)

01/07/2009

05/01/2009

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-007648-85-IT
(EUCTR)

03/06/2009

20/04/2009

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - ND

Systemic lupus erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Belimumab
Product Code: HGS1006
Product Name: Belimumab
Product Code: HGS1006

HUMAN GENOME SCIENCES INC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1620

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden

EUCTR2007-007648-85-ES
(EUCTR)

27/04/2009

25/02/2009

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057Estudio de continuación multicéntrico de belimumab (HGS1006, LymphoStat-B?), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) que completaron el protocolo de fase III HGS1006-C1056 o HGS1006-C1057

Systemic lupus erythematosus (SLE)Lupus Eritematoso Sistémico (LES)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

France;Czech Republic;Slovakia;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2007-007648-85-NL
(EUCTR)

07/04/2009

19/12/2008

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusions
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B; Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

EUCTR2007-007648-85-CZ
(EUCTR)

01/04/2009

26/01/2009

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Systemic lupus erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Benlysta ®
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

EUCTR2007-007648-85-GB
(EUCTR)

13/03/2009

19/01/2009

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Systemic lupus erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-007648-85-DE
(EUCTR)

06/02/2009

03/12/2008

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1620

Phase 3

Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of

NCT00732940
(ClinicalTrials.gov)

October 2008

8/8/2008

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

A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Belimumab 100 mg SC

Human Genome Sciences Inc.

GlaxoSmithKline

Terminated

18 Years

N/A

All

Phase 2

United States;Mexico

NCT00724867
(ClinicalTrials.gov)

August 2008

28/7/2008

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

Systemic Lupus Erythematosus

Biological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kg

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

268

Phase 3

United States;Canada

NCT00712933
(ClinicalTrials.gov)

May 30, 2008

8/7/2008

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

Systemic Lupus Erythematosus

Drug: belimumab

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

738

Phase 3

Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czechia;France;Germany;Hong Kong;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;United Kingdom;Australia;China;Costa Rica;Czech Republic

EUCTR2006-005177-21-AT
(EUCTR)

06/12/2007

26/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-005177-21-IT
(EUCTR)

20/09/2007

13/07/2007

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Belimumab
Product Code: HGS1006

HUMAN GENOME SCIENCES INC

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

EUCTR2006-005177-21-FR
(EUCTR)

11/09/2007

23/07/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2006-005177-21-NL
(EUCTR)

03/08/2007

04/06/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

EUCTR2006-005177-21-SE
(EUCTR)

08/06/2007

07/05/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

EUCTR2006-005177-21-GB
(EUCTR)

29/05/2007

02/01/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-005177-21-SK
(EUCTR)

17/05/2007

20/03/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2006-005177-21-ES
(EUCTR)

09/05/2007

09/03/2007

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76

Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

EUCTR2006-005177-21-BE
(EUCTR)

07/05/2007

29/01/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

EUCTR2006-005177-21-DE
(EUCTR)

03/05/2007

20/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

NCT00424476
(ClinicalTrials.gov)

May 2007

17/1/2007

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

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

GlaxoSmithKline

Completed

18 Years

N/A

All

865

Phase 3

Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-005177-21-CZ
(EUCTR)

23/04/2007

28/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

NCT00410384
(ClinicalTrials.gov)

December 2006

8/12/2006

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

GlaxoSmithKline

Completed

18 Years

N/A

All

819

Phase 3

United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom