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	EUCTR2018-004645-16-NL (EUCTR)	29/01/2020	29/10/2019	A study of belimumab in children with lupus	A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE	Lupus - SLE MedDRA version: 21.1;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: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan
2	EUCTR2018-004645-16-DE (EUCTR)	27/12/2019	18/09/2019	A study of belimumab in children with lupus	A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE	Lupus - SLE MedDRA version: 21.1;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: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
3	EUCTR2018-004645-16-ES (EUCTR)	16/12/2019	11/11/2019	A study of belimumab in children with lupus	A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE	Lupus - SLE MedDRA version: 21.1;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]		GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
4	NCT04179032 (ClinicalTrials.gov)	November 28, 2019	25/11/2019	Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)	A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Combination Product: Belimumab	GlaxoSmithKline	NULL	Recruiting	5 Years	17 Years	All	30	Phase 2	United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain
5	NCT04082416 (ClinicalTrials.gov)	October 10, 2019	1/9/2019	Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)	A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy	RemeGen	NULL	Recruiting	18 Years	65 Years	All	318	Phase 3	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
6	NCT03312907 (ClinicalTrials.gov)	March 1, 2018	13/10/2017	A Study to Evaluate the Efficacy and Safety of Belimumab Administered 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	Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper	GlaxoSmithKline	NULL	Active, not recruiting	18 Years	N/A	All	292	Phase 3	United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
7	NCT02885610 (ClinicalTrials.gov)	December 2015	26/8/2016	Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)	A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy	RemeGen	NULL	Completed	18 Years	65 Years	All	249	Phase 2	China
8	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
9	EUCTR2011-000368-88-IT (EUCTR)	04/02/2013	11/12/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE	Systemic lupus erythematosus MedDRA version: 14.1;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: Benlysta (belimumab) INN or Proposed INN: BELIMUMAB	GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy
10	EUCTR2011-000368-88-NL (EUCTR)	03/12/2012	02/07/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 17.1;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: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;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
11	NCT01705977 (ClinicalTrials.gov)	November 27, 2012	10/10/2012	Belimumab Assessment of Safety in SLE	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Active, not recruiting	18 Years	N/A	All	4019	Phase 4	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway
12	NCT01649765 (ClinicalTrials.gov)	September 7, 2012	23/7/2012	Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: belimumab 10mg/kg;Other: placebo	GlaxoSmithKline	Human Genome Sciences Inc., a GSK Company	Active, not recruiting	5 Years	17 Years	All	93	Phase 2	United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands
13	EUCTR2011-000368-88-ES (EUCTR)	27/07/2012	21/05/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 14.1;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: BENLYSTA? (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland
14	EUCTR2011-000368-88-GB (EUCTR)	13/06/2012	18/04/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 21.1;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: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom
15	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
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	NCT00479622 (ClinicalTrials.gov)	August 2007	25/5/2007	Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus	A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: TRU-015	Wyeth is now a wholly owned subsidiary of Pfizer	Emergent Product Development Seattle LLC	Terminated	18 Years	70 Years	Both	20	Phase 1	United States
17	EUCTR2011-000368-88-PL (EUCTR)		04/06/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus 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: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom
18	EUCTR2011-000368-88-Outside-EU/EEA (EUCTR)		17/02/2014	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 16.1;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: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	NA			Female: yes Male: yes	100		Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States

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

EUCTR2018-004645-16-NL
(EUCTR)

29/01/2020

29/10/2019

A study of belimumab in children with lupus

A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE

Lupus - SLE
MedDRA version: 21.1;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: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan

EUCTR2018-004645-16-DE
(EUCTR)

27/12/2019

18/09/2019

A study of belimumab in children with lupus

Trade Name: Benlysta
Product Name: Belimumab
Product Code: GSK1550188
INN or Proposed INN: BELIMUMAB
Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan

EUCTR2018-004645-16-ES
(EUCTR)

16/12/2019

11/11/2019

A study of belimumab in children with lupus

Lupus - SLE
MedDRA version: 21.1;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]

GlaxoSmithKline, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan

NCT04179032
(ClinicalTrials.gov)

November 28, 2019

25/11/2019

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Combination Product: Belimumab

GlaxoSmithKline

NULL

Recruiting

5 Years

17 Years

All

Phase 2

United States;Argentina;Germany;Japan;Mexico;Netherlands;Spain

NCT04082416
(ClinicalTrials.gov)

October 10, 2019

1/9/2019

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy

RemeGen

NULL

Recruiting

18 Years

65 Years

All

318

Phase 3

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

NCT03312907
(ClinicalTrials.gov)

March 1, 2018

13/10/2017

A Study to Evaluate the Efficacy and Safety of Belimumab Administered 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

Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper

GlaxoSmithKline

NULL

Active, not recruiting

18 Years

N/A

All

292

Phase 3

United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain

NCT02885610
(ClinicalTrials.gov)

December 2015

26/8/2016

Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy

RemeGen

NULL

Completed

18 Years

65 Years

All

249

Phase 2

China

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

EUCTR2011-000368-88-IT
(EUCTR)

04/02/2013

11/12/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE

Systemic lupus erythematosus
MedDRA version: 14.1;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: Benlysta (belimumab)
INN or Proposed INN: BELIMUMAB

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy

EUCTR2011-000368-88-NL
(EUCTR)

03/12/2012

02/07/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Systemic Lupus Erythematosus
MedDRA version: 17.1;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: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;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

NCT01705977
(ClinicalTrials.gov)

November 27, 2012

10/10/2012

Belimumab Assessment of Safety in SLE

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Systemic Lupus Erythematosus

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

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Active, not recruiting

18 Years

N/A

All

4019

Phase 4

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway

NCT01649765
(ClinicalTrials.gov)

September 7, 2012

23/7/2012

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: belimumab 10mg/kg;Other: placebo

GlaxoSmithKline

Human Genome Sciences Inc., a GSK Company

Active, not recruiting

5 Years

17 Years

All

Phase 2

United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;Italy;Netherlands

EUCTR2011-000368-88-ES
(EUCTR)

27/07/2012

21/05/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.

Systemic Lupus Erythematosus
MedDRA version: 14.1;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: BENLYSTA? (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland

EUCTR2011-000368-88-GB
(EUCTR)

13/06/2012

18/04/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Systemic Lupus Erythematosus
MedDRA version: 21.1;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: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom

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

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

NCT00479622
(ClinicalTrials.gov)

August 2007

25/5/2007

Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: TRU-015

Wyeth is now a wholly owned subsidiary of Pfizer

Emergent Product Development Seattle LLC

Terminated

18 Years

70 Years

Both

Phase 1

United States

EUCTR2011-000368-88-PL
(EUCTR)

04/06/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Systemic Lupus Erythematosus
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: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom

EUCTR2011-000368-88-Outside-EU/EEA
(EUCTR)

17/02/2014

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Systemic Lupus Erythematosus
MedDRA version: 16.1;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: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Female: yes
Male: yes

100

Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States