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 49. 全身性エリテマトーデス [臨床試験数:429,薬物数:477(DrugBank:150),標的遺伝子数:84,標的パスウェイ数:68] 

Searched query = "Systemic lupus erythematosus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT04060888January 3, 202022 October 2019A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: PlaceboJanssen Research & Development, LLCNot recruiting18 Years75 YearsAll190Phase 3China
2NCT04127747December 1, 20194 November 2019Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus ErythematosusA Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus ErythematosusAutoimmune DiseasesDrug: Standard dose of rituximab;Drug: Individualized dose of rituximabSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNot recruiting18 Years65 YearsAll86Phase 4
3NCT04058028October 31, 201928 October 2019Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) TherapySystemic Lupus Erythematosus (SLE)Drug: AMG 570;Drug: Placebo for AMG 570AmgenNot recruiting18 Years75 YearsAll300Phase 2
4NCT04136145October 28, 201911 November 2019Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy SubjectsAn Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy ParticipantsSystemic Lupus ErythematosusDrug: Belimumab for IV;Drug: Belimumab for SCGlaxoSmithKlineRecruiting18 Years45 YearsAll36Phase 1China
5NCT04128579October 1, 201928 October 2019Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative NephritisA Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus NephritisLupus Erythematosus;Lupus NephritisDrug: Itolizumab [Bmab 600];Drug: EQ001 PlaceboEquilliumBiocon LimitedRecruiting18 Years75 YearsAll56Phase 1United States
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PhaseCountries
6NCT04077684September 10, 201916 September 2019Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled TrialEfficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled TrialSystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalNot recruiting18 Years75 YearsAll500Phase 2
7NCT03843125September 9, 201911 November 2019A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: BaricitinibEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll1100Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom
8ChiCTR19000253762019-09-0127 August 2019Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical TrialLenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trialsystemic lupus erythematosusintervention group:lenalidomide 10mg qd;control group:placebo 10mg qd;Chinese Academy of Medical Sciences Peking Union Medical College HospitalRecruiting1870Bothintervention group:15;control group:15;Phase 4China
9NCT03953261September 1, 201926 August 2019Effect of Curcumin on Systemic Lupus ErythematosusEffect of Curcumin on Systemic Lupus ErythematosusSystemic Lupus ErythematosusDietary Supplement: Curcumin supplementLoma Linda UniversityNot recruiting18 YearsN/AAll68Phase 2
10NCT04082416September 201930 September 2019Study 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 ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapyRemeGenRecruiting18 Years65 YearsAll318Phase 3China
No.TrialIDDate_
enrollement
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PhaseCountries
11NCT03978520July 25, 20194 November 2019A Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus ErythematosusA Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: ABBV-105;Drug: Placebo for ABBV-105;Drug: Upadacitinib;Drug: Placebo for upadacitinibAbbVieRecruiting18 Years65 YearsAll310Phase 2United States;Argentina;Australia;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom
12NCT03951259July 24, 201916 September 2019Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: SM934;Drug: PlacebosRenJi HospitalJiangsu ZuoYou Medicine Co., Ltd.Recruiting18 Years70 YearsAll48Phase 2China
13NCT03656627June 27, 201922 October 2019Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbRecruiting18 YearsN/AAll72Phase 1United States
14ChiCTR19000229342019-06-205 May 2019Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusinStudy for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusinSystemic Lupus ErythematosusExperimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing;Nanjing University of Chinese Medicine Affiliated HospitalNot RecruitingBothExperimental group:20;control group:20;healthy control group:20;Phase 1China
15NCT03804723June 201928 January 2019Glucocorticoids Withdrawal in Early Systemic Lupus ErythematosusGlucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence TrialSystemic Lupus Erythematosus;Glucocorticoids;Therapy WithdrawalDrug: oral Prednisone 5mgUniversity of PisaNot recruiting18 Years85 YearsAll321N/A
No.TrialIDDate_
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PhaseCountries
16NCT03933943May 21, 201922 October 2019A Study of LY3361237 in Participants With Systemic Lupus ErythematosusA Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: LY3361237;Drug: PlaceboEli Lilly and CompanyRecruiting18 Years70 YearsAll24Phase 1United States
17NCT03949426May 1, 201911 November 2019Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy SubjectsA First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818Systemic Lupus ErythematosusDrug: KPG-818Kangpu Biopharmaceuticals, Ltd.Not recruiting18 Years55 YearsAll40Phase 1United States
18NCT03845517April 18, 201911 November 2019A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mgPfizerRecruiting18 Years75 YearsAll448Phase 2United States;Bulgaria;Canada;Hungary;Japan;Korea, Republic of;Poland;Romania;Taiwan
19NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
20NCT03917797April 2, 201929 April 2019Mesenchymal Stromal Cells (MSC´s) in Renal LupusDose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus ErythematosusLupus Erythematosus, Systemic;Lupus GlomerulonephritisBiological: MSC treatment;Drug: Standard of Care;Drug: PlaceboUniversidad de los Andes, ChileRecruiting18 Years75 YearsAll39Phase 2Chile
No.TrialIDDate_
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PhaseCountries
21NCT03920267March 26, 201927 May 2019Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165Bristol-Myers SquibbRecruiting18 Years75 YearsAll360Phase 2United States;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Taiwan
22NCT03771885March 16, 201918 March 2019BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.Lupus Erythematosus, SystemicDrug: BI 705564;Drug: PlaceboBoehringer IngelheimNot recruiting18 YearsN/AAll0Phase 1
23ChiCTR19000208032019-03-0128 January 2019Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trialEfficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trialsystemic lupus erythematosusintervention group:melatonin 6mg qn;control group:placebo qn;Chinese Academy of Medical Sciences Peking Union Medical College HospitalNot Recruiting1865Bothintervention group:88;control group:88;Post-marketChina
24EUCTR2018-000305-23-HU07/02/201928 February 2019NoA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareSystemic 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] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not known
CAS Number: 2229685-51-0
Current Sponsor code: BOS161721
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50 -
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Boston Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
25ChiCTR18000202862019-02-0114 January 2019Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosusEfficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluationSystemic Lupus ErythematosusGroup 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Nanjing University of Chinese Medicine Affiliated HospitalNot RecruitingBothGroup 2:40;Group 1:20;Phase 1 studyChina
No.TrialIDDate_
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PhaseCountries
26NCT03742037December 21, 20184 November 2019Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: PlaceboIdorsia Pharmaceuticals Ltd.Recruiting18 Years75 YearsAll500Phase 2United States;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Mexico;Poland;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Lithuania;Romania
27NCT03618056December 19, 20184 November 2019Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus ErythematosusA Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus ErythematosusHIV Infections;Systemic Lupus ErythematosusBiological: AIDSVAX® B/ENational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 Years50 YearsAll16Phase 1United States
28NCT03656562December 19, 20184 November 2019Study the Efficacy and Safety of VAY736 and CFZ533 in SLE PatientsA Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 PlaceboNovartis PharmaceuticalsRecruiting18 Years75 YearsAll120Phase 2Argentina;Australia;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand
29NCT03817424December 13, 201830 September 2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioRecruiting18 Years75 YearsAll32Phase 1United States;Poland;Spain
30EUCTR2018-001508-12-ES12/12/201828 February 2019Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)Systemic lupus erythematosus (SLE)
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]
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: ianalumab
Current Sponsor code: VAY736
Other descriptive name: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion
Route of administration of the placebo: Subcutaneous use
Product Code: CFZ533
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: iscalimab
Current Sponsor code: CFZ533
Other descriptive name: CFZ533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion
Route of administration of the placebo: Intravenous use
Novartis Farmacéutica, S.A.Authorised Female: yes
Male: yes
120Phase 2Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
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PhaseCountries
31NCT02525835December 1, 20181 October 2018Tissue Sodium in Autoimmune DiseaseTissue Sodium in Autoimmune DiseaseSystemic Lupus ErythematosusDietary Supplement: Low Dietary Sodium;Dietary Supplement: High Dietary SodiumVanderbilt UniversityNot recruiting18 YearsN/AAll0N/AUnited States
32NCT03878303November 28, 201825 March 2019Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: AC0058TA;Drug: Placebo AC0058TAACEA Therapeutics, Inc.Hangzhou ACEA Pharmaceutical Research Co., Ltd.Recruiting18 Years75 YearsAll32Phase 1United States
33NCT03724916November 26, 201811 November 2019A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Lupus Erythematosus, SystemicDrug: TAK-079;Drug: TAK-079 PlaceboMillennium Pharmaceuticals, Inc.Recruiting18 Years75 YearsAll24Phase 1United States
34ChiCTR18000193082018-11-1219 November 2018Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosusEfficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosussystemic lupus erythematosusNHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);The Third Affiliated Hospital, Southern Medical UniversityRecruiting1865BothNHMX:75;control:75;OtherChina
35EUCTR2018-001508-12-DE12/11/201819 November 2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)Systemic lupus erythematosus (SLE)
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]
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: ianalumab
Current Sponsor code: VAY736
Other descriptive name: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion
Route of administration of the placebo: Subcutaneous use
Product Code: CFZ533
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: iscalimab
Current Sponsor code: CFZ533
Other descriptive name: CFZ533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion
Route of administration of the placebo: Intravenous use
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
120Phase 2Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
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36NCT02633163October 26, 20188 April 2019Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory LupusSystemic Lupus ErythematosusDrug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo InfusionMedical University of South CarolinaRecruiting18 Years65 YearsAll81Phase 2United States
37NCT03626311October 23, 201822 July 2019Omega-3 Replacement With Krill Oil in Disease Management of SLEA Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Dietary Supplement: AKBM-3031;Other: PlaceboAker Biomarine Antarctic ASAmpel BioSolutions, LLCRecruiting18 YearsN/AAll76N/AUnited States;Canada
38NCT03747159October 1, 201810 December 2018Synergetic B-cell Immunomodulation in SLE - 2nd Study.A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Belimumab InjectionLeiden University Medical CenterDutch Kidney Foundation;GlaxoSmithKlineRecruiting18 YearsN/AAll30Phase 2Netherlands
39EUCTR2018-001392-21-NL25/09/201815 October 2018Synergetic B-cell immunomodulation in SLE – 2nd studyA randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosussystemic lupus erythematosus
MedDRA version: 20.0 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859
MedDRA version: 20.0 Level: LLT Classification code 10029142 Term: Nephritis systemic lupus erythematosus System Organ Class: 100000004857
MedDRA version: 20.0 Level: LLT Classification code 10042948 Term: Systemic lupus erythematosus syndrome aggravated System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: belimumab or benlysta
Pharmaceutical Form: Solution for solution for injection
Trade Name: anti-CD20 B cell depletion with Truxima
Product Name: truxima
Pharmaceutical Form: Concentrate for emulsion for infusion
Leiden University Medical CenterAuthorisedFemale: yes
Male: yes
30Phase 2Netherlands
40NCT03575156September 20, 20189 October 2018Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisMicroparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisSystemic Lupus Erythematosus;Systemic SclerodermaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxRecruiting18 YearsN/AAll200N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03527472August 23, 201822 October 2019Memantine for the Treatment of Cognitive Impairment in Systemic Lupus ErythematosusA Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Memantine;Drug: PlaceboVanderbilt University Medical CenterKleberg FoundationRecruiting18 Years60 YearsAll144Phase 2United States
42JPRN-JapicCTI-18397316/8/201816 July 2019A Study of Ustekinumab in Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicIntervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Janssen Pharmaceutical K.K.Recruiting1675BOTH500Phase 3Japan, Asia except Japan, North America, South America, Europe, Africa
43NCT03616912August 2, 201811 November 2019A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll750Phase 3United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine
44NCT03616964August 2, 201811 November 2019A Study of Baricitinib in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll750Phase 3United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain
45ChiCTR18000175402018-08-0120 August 2018A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvementA randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvementsystemic lupus erythematosus1:prednisone;2:Mycophenolate Mofetil;Ruijin HospitalRecruiting1865Both1:50;2:50;OtherChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03562065July 1, 20182 July 2018Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical CordTreatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical CordLupus Erythematosus;Stem Cell TransplantBiological: mesenchymal stem cellsAssistance Publique - Hôpitaux de ParisNot recruiting18 Years70 YearsAll10Phase 1/Phase 2France
47EUCTR2017-001489-53-HU14/06/201825 June 2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUSSystemic 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: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Stelara
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International NVAuthorisedFemale: yes
Male: yes
500Phase 3Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of
48EUCTR2017-001489-53-ES12/06/201818 June 2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUSSystemic 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: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Stelara
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International NVAuthorisedFemale: yes
Male: yes
500Phase 3Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of
49NCT03541564May 30, 20189 October 2018An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram EffectsA Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy SubjectsSystemic Lupus Erythematosus;Healthy ParticipantsDrug: BMS-986165;Drug: Moxifloxacin;Other: PlaceboBristol-Myers SquibbNot recruiting18 Years50 YearsAll84Phase 1United States
50EUCTR2017-001764-37-PT14/05/201821 May 2018An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSystemic 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]
Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Genentech, Inc.AuthorisedFemale: yes
Male: yes
240Phase 2Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-001489-53-DE08/05/201823 July 2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUSSystemic 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: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Stelara
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International NVAuthorisedFemale: yes
Male: yes
500Phase 3Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of
52EUCTR2017-001489-53-LT07/05/20185 June 2018Study of Ustekinumab in Subjects with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUSSystemic 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: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Trade Name: Stelara
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Current Sponsor code: CNTO1275
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Janssen-Cilag International NVAuthorisedFemale: yes
Male: yes
500Phase 3Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of
53NCT03312335May 1, 201811 June 2018Low-dose Interleukin-2 for Treatment of Systemic Lupus ErythematosusOpen-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Low-dose Aldesleukin (Proleukin®)Onur Boyman, MDRecruiting18 YearsN/AAll16Phase 2Switzerland
54NCT03556007May 1, 201822 October 2019A Study of NKTR-358 in Participants With Systemic Lupus Erythematosis (SLE)A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: NKTR-358;Drug: PlaceboNektar TherapeuticsEli Lilly and CompanyNot recruiting18 Years70 YearsAll48Phase 1United States
55NCT03492255April 12, 20186 May 2019CYCLONES - CYClophosphamide LOw Dose and No Extra SteroidCYCLONES - CYClophosphamide LOw Dose and No Extra SteroidSystemic Lupus Erythematosus (SLE)Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate MofetilUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloRecruiting18 YearsN/AAll232N/ABrazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03451422April 10, 20184 November 2019Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus ErythematosusA Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care TherapySystemic Lupus ErythematosusDrug: AMG 592;Drug: PlaceboAmgenRecruiting18 Years70 YearsAll132Phase 1/Phase 2United States;France;Germany;Poland
57EUCTR2017-001400-29-FR16/03/201820 August 2018Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES)Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE - MSC-LESTreatment of Systemic Lupus Erythematosus refractory to standard treatments.
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]
Product Name: ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD
Product Code: 0
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: 0
CAS Number: 0
Current Sponsor code: P150302
Other descriptive name: CSM allogéniques issues de cordons ombilicaux ( MTI-PP)
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: range
Concentration number: 1.106-4.106
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
10Phase 1;Phase 2France
58EUCTR2017-004060-35-HU12/03/201830 April 2019An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLEAn open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusSystemic 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: Body processes [G] - Immune system processes [G12]
Product Name: IPP-201101
Product Code: IPP-201101
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: IPP-201101
Current Sponsor code: IPP-201101
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
ImmuPharmaNot Recruiting Female: yes
Male: yes
75Phase 3United States;Hungary;Mauritius
59NCT03393013March 7, 201826 August 2019A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without NephritisA Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without NephritisSystemic Lupus Erythematosus;Lupus NephritisDrug: KZR-616;Drug: PlaceboKezar Life Sciences, Inc.Recruiting18 Years75 YearsAll72Phase 1/Phase 2United States;Australia;Colombia;Mexico
60ChiCTR18000150302018-03-015 March 2018A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus ErythematosusThe Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLESystemic Lupus ErythematosusCase series:add-on or replace dapagliflozin;Dept. Rheumatology, Renji Hospital South CampusNot Recruiting1870BothCase series:35;Phase 4 studyChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03312907March 1, 201811 November 2019A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVEA 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 ErythematosusDrug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steriod TaperGlaxoSmithKlineNot recruiting18 YearsN/AAll280Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
62NCT03480529March 1, 201816 September 2019Monitoring the IMmUological TOXicity of DrugsMonitoring the IMmUological TOXicity of DrugsArthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;HepatitisDrug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndromGroupe Hospitalier Pitie-SalpetriereInstitut National de la Santé Et de la Recherche Médicale, FranceNot recruiting18 YearsN/AAll662Early Phase 1France
63NCT03396393March 201829 January 2018Exploratory Study of DHA in Systemic Lupus Erythematosus PatientsA Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Dihydroartemisinin tablet;Drug: Placebo tabletKunming Pharmaceuticals, Inc.Not recruiting18 Years65 YearsAll120Phase 2
64NCT03427151February 27, 201823 April 2019Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusAn Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101ImmuPharmaNot recruiting18 YearsN/AAll62Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland
65NCT03371251February 7, 201811 February 2019Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareSystemic Lupus ErythematosusDrug: BOS161721;Drug: PlaceboBoston PharmaceuticalsRecruiting18 Years70 YearsAll186Phase 1/Phase 2United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03370263January 15, 201829 July 2019BENLYSTA® Special Drug Use InvestigationBENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use InvestigationSystemic Lupus ErythematosusDrug: BenlystaGlaxoSmithKlineRecruitingN/AN/AAll600Phase 2/Phase 3Japan
67EUCTR2016-003050-32-DE09/01/20187 January 2019A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVEA 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)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Current Sponsor code: GSK1550188
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
68NCT03407482January 9, 201811 November 2019An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus ErythematosusA Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: GDC-0853Genentech, Inc.Not recruiting18 Years76 YearsAll160Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;Germany;Portugal
69NCT03030118December 28, 201715 July 2019Study of Anti-Malarials in Incomplete Lupus ErythematosusStudy of Anti-Malarials in Incomplete Lupus ErythematosusSystemic Lupus ErythematosusDrug: Hydroxychloroquine;Drug: Placebo Oral CapsuleMilton S. Hershey Medical CenterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting15 Years45 YearsAll240Phase 2United States
70NCT03093402December 21, 201714 October 2019JBT-101 in Systemic Lupus Erythematosus (SLE)A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (ALE09)Systemic Lupus Erythematosus;SLE;LupusDrug: JBT-101;Drug: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Corbus Pharmaceuticals Inc.;Autoimmunity Centers of ExcellenceRecruiting18 Years70 YearsAll100Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2017-001764-37-BG15/12/201719 March 2018An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSystemic 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]
Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Genentech, Inc.AuthorisedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
72EUCTR2016-003050-32-ES05/12/201726 March 2018A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVEA 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)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Current Sponsor code: GSK1550188
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
GlaxoSmithKline, S.A.AuthorisedFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
73NCT03334851November 17, 201730 September 2019Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid ArthritisA PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITISSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: PF-06835375;Drug: PlaceboPfizerRecruiting18 Years70 YearsAll112Phase 1United States
74EUCTR2017-001764-37-ES07/11/201711 December 2017An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSystemic 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]
Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Roche Farma, S.A por delegación de Genentech, Inc.AuthorisedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
75ChiCTR-IOR-170128022017-09-262 October 2017Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE)Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE)systemic lupus erythematosus (SLE)the Controled Group:basic oral therapy;the Treated Group:basic oral therapy + Autologous blood transfusion with oxygen-ozone + acupoint injection with oxygen-ozone on ST 36;Guangdong Provincial Hospital of Chinese MedicineRecruiting1865Boththe Controled Group:30;the Treated Group:30;OtherChina
No.TrialIDDate_
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Last_Refreshed_
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76NCT03054259September 21, 201713 May 2019Rituximab Objective Outcome Measures Trial in SLEA Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus ErythematosusSystemic Lupus Erythematosus ArthritisDrug: Rituximab;Drug: Methylprednisolone;Drug: Normal SalineUniversity of LeedsRecruiting18 Years99 YearsAll30Phase 2United Kingdom
77NCT03254784September 13, 201711 February 2019A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet FormulationA Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: BMS-986165 Capsule;Drug: BMS-986165 TabletBristol-Myers SquibbNot recruiting18 Years50 YearsAll49Phase 1United States;Netherlands
78NCT03098823September 12, 201718 December 2018A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLEA Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Systemic;Lupus Erythematosus;FatigueDrug: RAYOS;Drug: PrednisoneAmpel BioSolutions, LLCNot recruiting18 Years99 YearsAll62Phase 4United States
79NCT03252587September 1, 20174 November 2019An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus ErythematosusA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbRecruiting18 Years75 YearsAll360Phase 2United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine
80NCT03262727September 1, 201711 June 2018The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsThe Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol);Drug: BMS-986165Bristol-Myers SquibbNot recruiting18 Years40 YearsFemale49Phase 1United States
No.TrialIDDate_
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81NCT03260166August 31, 201716 December 2017Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus ErythematosusAn Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus ErythematosusCutaneous Lupus Erythematosus;Systemic Lupus Erythematosus RashDrug: nicotinamideSecond Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China;Hunan Provincial Natural Science Foundation of China;National Key Clinical Specialty Construction Project of ChinaRecruiting18 Years65 YearsAll40Phase 2China
82NCT03288324August 23, 201726 August 2019Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With LupusA 3-part Open-label Study Assessing Safety, Tolerability, Pharmacokinetic and -Dynamic Profiles, and Efficacy of Tofacitinib in Young Adults From Age 18 to 45 With Moderate to Severe Skin Involvement Due to LupusCutaneous Lupus;Systemic Lupus ErythematosusDrug: TofacitinibChildren's Hospital Medical Center, CincinnatiPfizerRecruiting18 Years45 YearsAll20Phase 1/Phase 2United States
83NCT03219801August 1, 201716 December 2017Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus ErythematosusEvaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsSystemic Lupus ErythematosusBiological: mesenchymal stem cellsHebei Medical UniversityNot recruiting14 Years60 YearsAll10Early Phase 1China
84NCT03189017July 3, 201726 August 2019A Phase I Study of ICP-022 in Healthy SubjectsA Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating DoseSystemic Lupus Erythematosus;Rheumatoid ArthritisDrug: ICP-022;Drug: PlacebosInnocare Pharma Australia Pty LtdNot recruiting18 Years55 YearsMale64Phase 1Australia
85NCT02920424June 30, 201716 December 2017A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus ErythematosusA Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: JNJ-56022473;Drug: PlaceboJanssen Research & Development, LLCNot recruiting18 Years65 YearsAll0Phase 1Germany
No.TrialIDDate_
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86EUCTR2016-002950-19-DE19/06/201728 February 2019A Phase II Study of M2951 in SLEA Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/ASystemic Lupus Erythematosus (SLE)
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]
Product Name: Evobrutinib
Product Code: M2951
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Evobrutinib
CAS Number: 1415823-73-2
Current Sponsor code: M2951
Other descriptive name: M2951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Merck KGaANot Recruiting Female: yes
Male: yes
468Phase 2United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
87EUCTR2016-004574-17-ES08/06/20173 July 2017A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1 Level: LLT Classification code 10025134 Term: Lupus erythematosus System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CC-220
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.15-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: CC-220
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: CC-220
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CC-220
Other descriptive name: CC-220
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.45-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Celgene CorporationAuthorisedFemale: yes
Male: yes
280Phase 2Germany;Poland;Brazil;Belgium;Argentina;Canada;Mexico;Hungary;Italy;Colombia;Russian Federation;Spain;United States;Serbia
88NCT03122431June 5, 201711 June 2018Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune DiseasesRelevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse EffectsSystemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous LupusDrug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: Hydroxychloroquine highUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloRecruiting5 Years64 YearsAll296Phase 4Brazil
89ChiCTR-INC-170114972017-05-255 June 2017The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosusThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosusmoderate to severe active systemic lupus erythematosusImmunomodulation combined with traditional DMARDS treatment group:Immunomodulation combined with traditional DMARDS group: On the basis of glucocorticoid and traditional DMARDS treatment, metformin hydrochloride tablets 250mg, 3 times / day, oral; atorvastatin tablets 10mg, 1 times / day; in the first 4 weeks , 12 weeks and 24 weeks to assess the SELSNA-SLEDAI score table,traditional DMARDS treatment group:Traditional DMARDS treatment group: the use of glucocorticoid and traditional DMARDS treatment. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyNot RecruitingBothImmunomodulation combined with traditional DMARDS treatment group:60;traditional DMARDS treatment group:60;New Treatment Measure Clinical StudyChina
90ChiCTR-INR-170114952017-05-255 June 2017The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosusThe efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosusPrimary mild to moderate systemic systemic lupus erythematosusImmunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.;The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyRecruitingBothImmunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30;New Treatment Measure Clinical StudyChina
No.TrialIDDate_
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91EUCTR2016-000625-39-BG17/05/201728 February 2019A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTESystemic 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]
Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Current Sponsor code: MEDI 546
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
AstraZeneca ABAuthorisedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
92NCT03125486May 17, 201712 March 2018Compassionate Use for Subcutaneous (SC) BelimumabCompassionate Use for Subcutaneous (SC) BelimumabSystemic Lupus ErythematosusDrug: SC belimumab 200 mgGlaxoSmithKlineNot recruiting18 YearsN/AAllN/AUnited States
93NCT03171194April 27, 201713 May 2019Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus ErythematosusA Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus ErythematosusSystem; Lupus ErythematosusDrug: Low Dose Mesenchymal Stem Cells (MSCs)Medical University of South CarolinaNot recruiting18 Years65 YearsAll6Phase 1United States
94JPRN-JapicCTI-17354426/4/201716 July 2019TULIP SLE LTEA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusIntervention name : Anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
AstraZenecaNot Recruiting18BOTH50Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania
95NCT03355482April 10, 201716 December 2017MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLEMRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLESystemic Lupus Erythematosus ArthritisDrug: Methylprednisolone;Drug: PlacebosOklahoma Medical Research FoundationBristol-Myers SquibbRecruiting18 Years70 YearsAll40Phase 2United States
No.TrialIDDate_
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96NCT03159936April 3, 201717 June 2019Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)Discoid Lupus Erythematosus;Systemic Lupus ErythematosusBiological: Tofacitinib citrateTufts Medical CenterPfizerRecruiting18 Years65 YearsAll12Early Phase 1United States
97NCT03042260March 1, 201711 March 2019Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus ErythematousProphylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled TrialLupus Erythematosus, SystemicDrug: Trimethoprim-Sulfamethoxazole;Drug: Placebo Oral TabletInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNational Council of Science and Technology, MexicoRecruiting18 YearsN/AAll310Phase 4Mexico
98NCT03030976March 201716 December 2017A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: cyclophosphamide;Drug: anti-CD19-CAR-T cellsShanghai GeneChem Co., Ltd.RenJi HospitalRecruiting18 Years69 YearsAll5Phase 1China
99NCT02962960February 14, 201728 January 2019A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin ManifestationsA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.Systemic Lupus ErythematosusDrug: Anifrolumab;Drug: PlaceboAstraZenecaNot recruiting18 Years70 YearsAll36Phase 2United States;Hungary;Korea, Republic of;Poland
100EUCTR2016-003246-93-PL26/01/201711 June 2018The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestationsSystemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ANIFROLUMAB
CAS Number: 1326232-46-5
Current Sponsor code: MEDI-546
Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Astrazeneca ABAuthorisedFemale: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
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101NCT02880852January 23, 201719 November 2018Belimumab Phase I Study in Chinese Subjects With Systemic Lupus ErythematosusA Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1550188 in Chinese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineNot recruiting18 YearsN/AAll20Phase 1China
102NCT02908100January 19, 201714 October 2019Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus ErythematosusA Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GDC-0853 (high dose);Drug: GDC-0853 (low dose);Drug: PlaceboGenentech, Inc.Not recruiting18 Years75 YearsAll254Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Portugal;Spain;Taiwan;United Kingdom;France;Thailand
103NCT02955615January 18, 201718 March 2019ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: ILT-101;Drug: PlaceboIltoo PharmaNot recruiting18 YearsN/AAll100Phase 2Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;Spain
104NCT02975336January 4, 201711 November 2019A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: M2951EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyNot recruiting18 Years75 YearsAll480Phase 2United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan
105EUCTR2016-003246-93-HU06/12/201630 April 2019The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestationsSystemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Astrazeneca ABNot Recruiting Female: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
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106EUCTR2016-001039-11-GB16/11/201630 April 2018A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus ErythematosusA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSystemic 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]
Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Genentech, Inc.AuthorisedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
107ChiCTR-IPR-160094512016-11-0118 April 2017The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus ErythematosusThe Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus ErythematosusSystemic Lupus ErythematosusIL-2 group:IL-2;IL-2 + Rapamycin group :IL-2 and Rapamycin;non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs;the Second Hospital of Shanxi Medical UniversityNot Recruiting1880BothIL-2 group:20;IL-2 + Rapamycin group :20;non IL-2 or IL-6 antagonist group :20;Post-marketChina
108NCT02847598October 20, 20164 November 2019Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic ManifestationsSystemic Lupus Erythematosus;Active Cutaneous Lupus ErythematosusDrug: BIIB059;Drug: PlaceboBiogenNot recruiting18 Years75 YearsAll264Phase 2United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand
109NCT02953821October 13, 201622 October 2019Acthar Gel for Active Systemic Lupus Erythematosus (SLE)A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose CorticosteroidsLupus Erythematosus, SystemicDrug: Acthar Gel;Drug: Placebo GelMallinckrodtNot recruiting18 YearsN/AAll172Phase 4United States;Argentina;Chile;Mexico;Peru;Colombia
110JPRN-JapicCTI-18395710/10/201616 July 2019A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusIntervention name : M2951 (Other Name: Evobrutinib)
Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks.
Intervention name : M2951 (Other Name: Evobrutinib)
Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks.
Intervention name : M2951 (Other Name: Evobrutinib)
Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks.
Merck Serono Co., Ltd.Merck KGaARecruiting1875BOTH451Phase 2
No.TrialIDDate_
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111NCT02779153October 201630 September 2019Acthar SLE (Systemic Lupus Erythematosus)Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE);Repository Corticotropin InjectionDrug: Acthar low dose (40 U);Drug: Acthar high dose (80 U)NYU Langone HealthMallinckrodtNot recruiting18 YearsN/AAll0Phase 4United States
112NCT02842814October 201629 July 2019Prediction of Relapse Risk in Stable Systemic Lupus ErythematosusEvaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From ChinaSystemic Lupus ErythematosusOther: Drug free;Drug: HCQ;Drug: GC+HCQPeking Union Medical College HospitalXiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial HospitalRecruiting18 Years60 YearsAll350N/AChina
113EUCTR2015-004457-40-DE19/09/201628 February 2019A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUSSUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0 Level: LLT Classification code 10040967 Term: SLE System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Dapirolizumab pegol
Current Sponsor code: DZP
Other descriptive name: CDP7657
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solvent for solution for infusion
Route of administration of the placebo: Intravenous use
UCB Biopharma SPRLNot Recruiting Female: yes
Male: yes
160Phase 2United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
114EUCTR2016-000625-39-HU18/08/20167 January 2019A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTESystemic 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]
Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Current Sponsor code: MEDI 546
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
AstraZeneca ABAuthorisedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
115EUCTR2016-000488-17-AT08/08/201630 April 2019A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)Systematic 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: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Aldesleukin
CAS Number: 110942-02-4
Other descriptive name: INTERLEUKIN-2
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 1.2-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
ILTOO PHARMANot Recruiting Female: yes
Male: yes
100Phase 2Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
No.TrialIDDate_
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Last_Refreshed_
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116EUCTR2015-003341-25-DE29/07/201628 February 2019A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.Systemic Lupus Erythematosus
MedDRA version: 19.0 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]
Product Code: IPP-201101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPP-201101
Current Sponsor code: IPP-201101
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Subcutaneous use
ImmuPharma SANot Recruiting Female: yes
Male: yes
200Phase 3France;United States;Hungary;Germany;United Kingdom
117NCT03155477June 10, 201616 December 2017Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin DEffect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) SerumSLEDietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placeboSaiful Anwar HospitalNot recruiting18 Years45 YearsFemale39N/A
118NCT02804763June 2, 201622 July 2019A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus ErythematosusA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: Placebo;Drug: Dapirolizumab pegol (DZP)UCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll182Phase 2United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine
119NCT02514967June 201616 December 2017CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNot recruiting18 YearsN/AAll3Phase 3Georgia
120NCT02741960May 24, 201630 September 2019The Effect of Metformin on Reducing Lupus FlaresA Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: metformin;Drug: placeboRenJi HospitalNot recruiting18 Years70 YearsAll180Phase 4China
No.TrialIDDate_
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Last_Refreshed_
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121NCT02932137May 5, 201611 June 2018Anti-infection of Low-does IL-2 in SLEPotential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLESystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalNot recruiting18 Years60 YearsAll30N/AChina
122EUCTR2015-003341-25-HU02/05/201618 June 2018A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.Systemic Lupus Erythematosus
MedDRA version: 18.1 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 Code: IPP-201101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPP-201101
Current Sponsor code: IPP-201101
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Subcutaneous use
ImmuPharma SANot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Hungary;Germany
123NCT02331810April 201613 June 2016Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female PatientsA Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus PatientSystemic Lupus ErythematosusDrug: SAR113244;Drug: placeboSanofiNot recruiting18 Years75 YearsBoth0Phase 1
124NCT02618967March 28, 201617 September 2018Single Ascending Dose Study of AMG 570 in Healthy SubjectsA Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy SubjectsSystemic Lupus ErythematosusBiological: AMG 570;Biological: AMG 570 Matching PlaceboAmgenNot recruiting18 Years65 YearsAll56Phase 1United States
125NCT02708095March 24, 20163 December 2018A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll314Phase 2United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan
No.TrialIDDate_
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Last_Refreshed_
on
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126JPRN-JapicCTI-16335901/3/20162 April 2019A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHHA Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHHSystemic Lupus Erythematosus (SLE)Intervention name : Baricitinib
INN of the intervention : Baricitinib
Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks
Eli Lilly Japan K.K.18BOTHPhase 2
127NCT02711813March 201611 June 2018TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current TreatmentStudy to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant TherapyLupus Erythematosus, SystemicDrug: TAB08;Other: PlaceboTheramab LLCNot recruiting18 Years60 YearsAll60Phase 2Russian Federation
128NCT02725515February 16, 201626 August 2019A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease ActivitySystemic Lupus ErythematosusBiological: XmAb5871;Biological: Placebo to match XmAb5871Xencor, Inc.PPD;ICON plcNot recruiting18 Years65 YearsAll105Phase 2United States
129NCT02925351January 25, 201611 November 2019Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory DiseasesThe Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory DiseasesAutoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu ArteritisProcedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission TomographyJonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll8N/AUnited States
130NCT02483624January 20168 February 20163,3'-Diindolylmethane in Patients With Systemic Lupus ErythematosusA Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)SLEDrug: BR-DIM;Drug: PlaceboNorth Shore Long Island Jewish Health SystemNot recruiting18 Years50 YearsFemale6Phase 1
No.TrialIDDate_
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131NCT02660944January 201626 August 2019A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: RSLV-132;Drug: PlaceboResolve TherapeuticsNot recruiting18 Years70 YearsAll64Phase 2United States
132NCT02677688January 201625 March 2019Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE TreatmentSerologically Active Adult Systemic Lupus ErythematosusBiological: Autologous EBV specific CTL infusionNantes University HospitalRecruiting18 YearsN/AAll10Phase 1/Phase 2France
133ChiCTR-ONC-150075472015-12-0518 April 2017Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort studyStudy of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosussystemic lupus erythematosusThe combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);Zhejiang Chinese Medical UniversityRecruiting1860BothThe combination of Chinese and western group:264;Treating by Western Medicine group:264;New Treatment Measure Clinical StudyChina
134JPRN-UMIN0000253282015/12/052 April 2019A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritissystemic lupus erythematosusTacrolimus
Mycophenolate Mofetil
The University of Hong KongRecruiting18years-old75years-oldMale and Female200Not selectedJapan,Asia(except Japan)
135NCT02074020December 201524 August 2015CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNot recruiting18 YearsN/ABoth0Phase 3
No.TrialIDDate_
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Last_Refreshed_
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136NCT02609789December 201525 March 2019A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus ErythematosusA Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus Erythematosus;HealthyDrug: JNJ-55920839;Drug: PlaceboJanssen Research & Development, LLCNot recruiting18 Years55 YearsAll72Phase 1United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan
137NCT02885610December 201529 July 2019Study 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 ErythematosusBiological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapyRemeGenNot recruiting18 Years65 YearsAll249Phase 2China
138NCT02537028November 30, 201516 December 2017MSC2364447C Phase 1b in Systemic Lupus ErythematosusA Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: MSC2364447C;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaANot recruiting18 Years65 YearsAll24Phase 1United States;Bulgaria
139EUCTR2015-001341-86-DE19/11/20157 January 2019Phase IIb study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus ErythematosusSystemic 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]
Product Name: IFN-Kinoid
Product Code: IFN-K
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not yet assigned
Current Sponsor code: IFN-K DS
Other descriptive name: IFN-Kinoid Drug Substance
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 380-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use
Neovacs S.A.AuthorisedFemale: yes
Male: yes
178Phase 2United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
140NCT02477150November 201516 September 2019Safety and Immunogenicity of a Zoster Vaccine in SLEImmunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled TrialSystemic Lupus ErythematosusBiological: Zostavax;Biological: placeboTuen Mun HospitalNot recruiting18 YearsN/AAll90Phase 4China
No.TrialIDDate_
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PhaseCountries
141NCT02349061October 15, 20154 March 2019A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant MedicationJanssen Research & Development, LLCNot recruiting18 Years75 YearsAll102Phase 2United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom
142NCT02429934October 201529 April 2019Abatacept for SLE Arthritis (IM101-330)Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus ArthritisDrug: abatacept;Drug: PlaceboUniversity of California, Los AngelesBristol-Myers SquibbRecruiting18 YearsN/AAll64Phase 1/Phase 2United States
143NCT02554019September 28, 201520 August 2018Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus ErythematosusA Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: BT063;Biological: PlaceboBiotestNot recruiting18 Years75 YearsAll36Phase 2Belarus;Georgia;Poland;Serbia
144EUCTR2014-005526-35-PL12/09/201530 April 2018Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)Systemic Lupus Erythematosus
MedDRA version: 19.1 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BT063
Product Code: BT063
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BT063
Current Sponsor code: BT063
Other descriptive name: BT063
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Biotest AGNot RecruitingFemale: yes
Male: yes
36Phase 2Serbia;Belarus;Poland;Georgia
145JPRN-UMIN0000208592015/09/012 April 2019Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus ErythematosusSystemic Lupus Erythematosus.two-month Royal Jelly (2 gm) treatmentFaculty of medicine, University of Assiut, Assiut 71516, Egypt.Not Recruiting8years-old17years-oldMale and Female30Not selectedAfrica
No.TrialIDDate_
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146NCT02665364September 20156 May 2019Study of IFN-K in Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: IFN-Kinoid;Other: Placebo;Other: ISA 51NeovacsNot recruiting18 Years65 YearsAll178Phase 2United States;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Taiwan;Thailand
147NCT02535689August 28, 201520 August 2018Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus ErythematosusSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic StudiesSystemic Lupus ErythematosusDrug: Tofacitinib;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years100 YearsAll34Phase 1United States
148EUCTR2014-004632-19-LT20/08/201528 February 2019A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus ErythematosusSystemic 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]
Product Name: Anifrolumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
AstraZeneca ABNot Recruiting Female: yes
Male: yes
360Phase 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
149JPRN-JapicCTI-15307701/8/20152 April 2019A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusIntervention name : Lulizumab pegol
Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results.
Control intervention name : null
Bristol-Myers Squibb K.K.1870BOTH350Phase 2
150EUCTR2014-004633-96-GB16/07/201528 February 2019A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus ErythematosusSystemic 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]
Product Name: Anifrolumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Anifrolumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
AstraZeneca ABNot Recruiting Female: yes
Male: yes
450Phase 3United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
151NCT02446899July 9, 201529 July 2019Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesNot recruiting18 Years70 YearsAll373Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
152NCT02437890July 201519 November 2018A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: ALX-0061;Biological: PlaceboAblynxNot recruiting18 Years64 YearsAll312Phase 2United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic
153NCT02444728July 201516 December 2017Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLECyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus ErythematosusThrombocytopeniaDrug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: MethylprednisoloneChinese SLE Treatment And Research GroupPeking Union Medical College HospitalRecruiting18 Years70 YearsAll220Phase 3China
154NCT02477254July 201531 October 2016Long-term Immunogenicity of a HPV Vaccine in SLELong-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control StudySystemic Lupus ErythematosusBiological: VaccinationTuen Mun HospitalNot recruiting18 Years35 YearsFemale84N/AChina
155NCT02533570July 201516 December 2017Dose Ranging Study of Brentuximab Vedotin in Adults With LupusA Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Brentuximab vedotin;Drug: PlaceboSeattle Genetics, Inc.Not recruiting18 YearsN/AAll20Phase 2United States
No.TrialIDDate_
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PhaseCountries
156EUCTR2014-002984-14-BG05/06/20158 May 2017International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupusA multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. -Systemic lupus erythematosus
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACT-334441
Pharmaceutical Form: Capsule, hard
Other descriptive name: ACT-334441
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5,1,2,-4
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
ACTELION Pharmaceuticals LtdNot RecruitingFemale: yes
Male: yes
64Phase 2Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria
157NCT02472795June 1, 201516 July 2018Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Placebo;Drug: ACT-334441Idorsia Pharmaceuticals Ltd.Not recruiting18 Years65 YearsAll64Phase 2United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine
158NCT02465580June 201529 June 2015A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusA Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hrIL-2 active;Drug: hrIL-2 placeboPeking University People's HospitalMonash University;Beijing SL Pharmaceutical Company LtdRecruiting18 Years65 YearsBoth60Phase 2China
159EUCTR2014-005418-45-SE04/05/201522 May 2017Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLERheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Plaquenil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Christine BengtssonSolveig Wållberg-JonssonNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
160NCT01773616April 201512 February 2018Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus NephritisPhase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus NephritisSystemic Lupus Erythematosus, Lupus NephritisDrug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisoloneImperial College LondonKarolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study GroupNot recruiting12 Years75 YearsAll24Phase 3United Kingdom
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
161NCT02548936April 201521 September 2015Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLEEfficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind TrialAtherosclerosisDrug: Ezetimibe+Simvastatin Drug CombinationPeking Union Medical College HospitalRecruiting18 Years65 YearsBoth30Phase 0China
162NCT02504645March 201523 April 2019A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusA 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: IPP-201101;Drug: Placebo;Other: Standard of CareImmuPharmaNot recruiting18 Years70 YearsAll202Phase 3United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy
163NCT02307643February 201516 December 2017Exploratory Study of MT-1303 in Systemic Lupus Erythematosus PatientsAn Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)Systemic Lupus ErythematosusDrug: MT-1303 Low dose;Drug: MT-1303 High doseMitsubishi Tanabe Pharma CorporationNot recruiting20 Years64 YearsAll17Phase 1Japan
164NCT01845740January 201512 October 2015Phase Ib Study of SC Milatuzumab in SLEA Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus NephritisDrug: milatuzumab;Drug: PlaceboImmunomedics, Inc.Department of DefenseRecruiting18 YearsN/ABoth30Phase 1/Phase 2United States
165JPRN-jRCTs07118005226/12/201410 September 2019Control of steroid-associated osteonecrosis of the femoral head in SLE patientsClinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - Nonesystemic lupus erythematosus;D008180Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidogrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Yasuharu NakashimaRecruiting20 years-oldNot applicableBoth150Phase 2none
No.TrialIDDate_
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166NCT02265744November 13, 201422 October 2019Safety and Efficacy Study of a Biologic to Treat Systemic Lupus ErythematosusA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus ErythematosusLupusDrug: BMS-931699;Drug: Placebo matching BMS-931699Bristol-Myers SquibbNot recruiting18 Years70 YearsAll730Phase 2Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Argentina;Brazil;Canada;United States;Qatar
167NCT02306629November 201425 May 2015Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the BloodAn Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese SubjectsSystemic Lupus ErythematosusBiological: Epratuzumab sc;Biological: Epratuzumab ivUCB Biopharma S.P.R.L.Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors LaboratoryNot recruiting18 Years50 YearsBoth42Phase 1United Kingdom
168NCT02321709November 20149 May 2016Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female PatientsA Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus PatientsSystemic Lupus ErythematosusDrug: SAR113244;Drug: placeboSanofiNot recruiting18 Years75 YearsBoth21Phase 1Germany
169NCT02080195October 201416 December 2017Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLELupus Erythematosus;Graft-versus-host DiseaseDrug: Cyclophosphamide;Drug: Sodium-2-mercapto ethane sulphonate;Drug: Fludarabine monophosphate;Drug: Tacrolimus;Drug: Mofetil;Drug: Rabbit antithymocyte globulinSidney Kimmel Comprehensive Cancer CenterNot recruiting18 Years75 YearsAll1Phase 1/Phase 2United States
170NCT02102594October 201410 December 2018Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinRecruiting18 Years75 YearsAll18Phase 2Germany
No.TrialIDDate_
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Last_Refreshed_
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171NCT02270970October 201416 December 2017Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacyEvaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding PolypharmacySystemic Lupus ErythematosusBiological: belimumabOklahoma Medical Research FoundationGlaxoSmithKlineRecruiting16 Years70 YearsAll20Phase 4United States
172NCT02281513October 201427 May 2019Activity and Nutrition Trial in Lupus to Energize and RenewActivity and Nutrition Trial in Lupus to Energize and RenewSystemic Lupus Erythematosus;Physical Activity;SleepOther: Smartphone Application;Other: Fitbit Activity Monitor;Other: Coaching SessionsNorthwestern UniversityNot recruiting18 YearsN/AAll12N/AUnited States
173NCT02185040September 16, 20142 September 2019A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: CC-220;Drug: PlaceboCelgeneNot recruiting18 YearsN/AAll42Phase 2United States
174NCT02066311September 201420 August 2018Nelfinavir in Systemic Lupus ErythematosusNelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical TrialSystemic Lupus ErythematosusDrug: NelfinavirNorthwell HealthNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years65 YearsAll15Phase 2United States
175JPRN-UMIN0000082302014/08/012 April 2019Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosusSystemic lupus erythematosusObjectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment.
1. Clopidgrel Bisulfate (Plavix)
Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days.
2. Pitavastatin Calcium (LIVALO)
Taking a dose of 2mg once daily.
3. Tocopherol Acetate (Juvela)
Taking a dose of 100mg three times daily (total of 300mg daily).
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu UniversityRecruiting20years-oldNot applicableMale and Female150Phase 2Japan
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176NCT02070978July 29, 20141 April 2019Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoNot recruiting18 YearsN/AAll253Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom
177EUCTR2013-005362-19-DE17/07/201417 July 2017Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVABMyasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Velcade®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3,5-
Charité - Universitätsmedizin BerlinAuthorisedFemale: yes
Male: yes
Phase 2Germany
178NCT02194400July 201421 December 2015Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus ErythematosusA Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: RSLV-132Resolve TherapeuticsNot recruiting18 Years70 YearsBoth32Phase 1United States
179NCT02124798May 20, 201411 June 2018A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an AutoinjectorAn Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDevice: Belimumab autoinjectorGlaxoSmithKlineNot recruiting18 YearsN/AAll95Phase 2United States
180NCT02119156May 13, 201421 January 2019Belimumab Treatment Holiday and Treatment Re-start Study in Lupus PatientsAn Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus SubjectsSystemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineNot recruiting18 YearsN/AAll80Phase 3Korea, Republic of;China;Japan;United States
No.TrialIDDate_
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181EUCTR2014-000488-42-NL12/05/201430 April 2019Synergetic B-cell immunomodulation in SLEThe SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBioseSystemic lupus erythematosus
MedDRA version: 17.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: rituximab
Product Name: Rituximab
Pharmaceutical Form: Infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: Teng-001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Trade Name: Benlysta
Product Name: Belimumab
Pharmaceutical Form: Infusion
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Current Sponsor code: Teng-001
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 10-
Leiden University Medical CenterNot Recruiting Female: yes
Male: yes
15Phase 2Netherlands
182NCT01956188May 201416 December 2017Omega 3 in LES and APSEfficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid SyndromeSystemic Lupus Erythematosus;Primary Antiphospholipid SyndromeDietary Supplement: EPA and DHA supplementation;Dietary Supplement: PlaceboUniversity of Sao PauloNot recruiting20 Years45 YearsFemale22N/ABrazil
183NCT02106897April 30, 201416 December 2017Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus ErythematosusA Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Healthy VolunteersDrug: BIIB059;Drug: PlaceboBiogenNot recruiting18 YearsN/AAll109Phase 1United States
184JPRN-UMIN0000124782014/04/0116 July 2019Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosusOpen label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosussystemic lupus erythematosus cutaneous lupus erythematosusTreatment with HydroxychloroquineDepartment of Internal Medicine, Teikyo University School of MedicineRecruitingNot applicableNot applicableMale and Female10Not selectedJapan
185JPRN-UMIN0000135082014/03/282 April 2019A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trialSystemic lupus erythmatosussaline
bortezomib(1.3mg/m2)
2times/week total 8times.
Tohoku university hospitalNot Recruiting20years-old65years-oldMale and Female14Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
186NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
187EUCTR2013-001599-40-DE03/01/201410 July 2015Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus.Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN). A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUNPatients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.
MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0 Level: PT Classification code 10067657 Term: Systemic lupus erythematosus disease activity index increased System Organ Class: 10022891 - Investigations ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Proleukin
Product Name: Proleukin
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Aldesleukin
CAS Number: 110942-02-4
Other descriptive name: ALDESLEUKIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.3-
Charité - Universitätsmedizin BerlinNot RecruitingFemale: yes
Male: yes
Phase 1/2AGermany
188NCT02041091January 201418 January 2016A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With LupusPharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled SyringeEli Lilly and CompanyNot recruiting18 YearsN/ABoth226Phase 3United States;Korea, Republic of;Puerto Rico;Mexico
189NCT02270957January 201416 December 2017Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical ApproachesClarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)Systemic Lupus ErythematosusBiological: Abatacept;Other: PlaceboOklahoma Medical Research FoundationBristol-Myers SquibbRecruiting18 Years70 YearsAll60Phase 2United States
190NCT02558517January 201422 August 2016Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic LupusEvaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic LupusSystemic Lupus ErythematosusDrug: prednisone discontinuationGroupe Hospitalier Pitie-SalpetriereRecruiting18 Years75 YearsBoth136Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
191NCT01972568December 201316 December 2017Efficacy and Safety of Atacicept in Systemic Lupus ErythematosusA Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: PlaceboEMD SeronoNot recruiting18 YearsN/AAll306Phase 2United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine
192NCT01946880November 20, 201326 August 2019Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;SLEDrug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years70 YearsAll102Phase 2United States
193JPRN-UMIN0000122272013/11/062 April 2019A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosusSystemic lupus erythmatosusbortezomib(1.3mg/m2)
2times/week total 8times.
saline
Tohoku university hospitalNot Recruiting20years-old65years-oldMale and Female14Phase 2Japan
194NCT01894360October 14, 201316 December 2017A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy SubjectsA Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or AutoinjectorSystemic Lupus ErythematosusDrug: Belimumab 200 mg/mLGlaxoSmithKlineNot recruiting18 Years55 YearsAll81Phase 1United States
195NCT01953835October 4, 201316 December 2017A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184Systemic Lupus ErythematosusDrug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulationGlaxoSmithKlineNot recruiting18 Years65 YearsAll37Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
196NCT02084238August 201319 October 2017Low-dose IL-2( Interleukin-2) Treatment in SLESafety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Interleukin-2Peking University People's HospitalMonash UniversityNot recruiting18 Years65 YearsAll40N/AChina
197NCT01709474June 201319 October 2017Vitamin D3 Treatment in Pediatric Systemic Lupus ErythematosusVitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Vitamin D3 6000 IU;Drug: Vitamin D3 400 IUNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting5 Years20 YearsAll7Phase 2United States
198NCT01753193March 28, 201327 August 2018An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in AdultsA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: MEDI-546MedImmune LLCNot recruiting18 Years68 YearsAll218Phase 2United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic
199NCT01777256March 1, 201316 December 2017An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: PlaceboGlaxoSmithKlineNot recruiting18 Years75 YearsAll51Phase 2Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic
200NCT01729455February 21, 201311 November 2019Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus RegistryA 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)Systemic Lupus ErythematosusBiological: BENLYSTA;Other: SLE treatmentHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineRecruiting18 YearsN/AAll3000Phase 2United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Slovakia;Spain;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
201EUCTR2012-001645-41-DE19/02/20131 December 2014A study to assess the efficacy and safety of GSK2586184 in SLEAn adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus.Systemic Lupus Erythematosus
MedDRA version: 16.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: GSK2586184
Product Code: GSK2586184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: GSK2586184
CAS Number: 1206163-45-2
Current Sponsor code: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: GSK2586184
Product Code: GSK2586184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: GSK2586184
CAS Number: 1206163-45-2
Current Sponsor code: GSK2586184
Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline Research and Development LimitedNot RecruitingFemale: yes
Male: yes
250Phase 2India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of;Thailand;Russian Federation;Chile;Estonia;Hong Kong;Greece;Spain
202NCT01632241February 19, 201326 August 2019Efficacy 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 ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll503Phase 4United States;Brazil;Colombia;France;South Africa;United Kingdom
203NCT01395745February 201316 December 2017CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: blisibimod;Drug: PlaceboAnthera PharmaceuticalsNot recruiting18 YearsN/AAll442Phase 3Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand
204NCT01781611February 201316 December 2017Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)Dipyridamole Assessment for Flare Reduction in SLESystemic Lupus ErythematosusDrug: extended release dipyridamole 200mg/aspirin 25mg;Drug: 81mg aspirinOklahoma Medical Research FoundationRecruiting18 Years70 YearsAll50N/AUnited States
205EUCTR2011-005667-25-HU22/01/201327 October 2014Belimumab Assessment of Safety in SLE (BASE)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 BelimumabLupus 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 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Other descriptive name: Benlysta
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)AuthorisedFemale: yes
Male: yes
5000Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemax
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size
PhaseCountries
206EUCTR2011-005667-25-EE08/01/201328 February 2019Belimumab Assessment of Safety in SLE (BASE)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 BelimumabLupus 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 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
CAS Number: 356547-88-1
Other descriptive name: Benlysta
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)Authorised Female: yes
Male: yes
4000Phase 4Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
207NCT01741012January 201329 June 2015Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus PatientsPhase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: GardasilWayne State UniversityMerck Sharp & Dohme Corp.Recruiting18 Years50 YearsFemale40Phase 1United States
208NCT01764594January 20133 August 2015Safety Study of CDP7657 in Patients With Systemic Lupus ErythematosusA Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus ErythematosusImmune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue DiseaseBiological: CDP7657;Other: PlaceboUCB PharmaBiogenNot recruiting18 Years75 YearsBoth24Phase 1Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;Spain
209NCT01753401December 20125 December 2016Acthar for the Treatment of Systemic Lupus Erythematosus in Patients With a History of Persistently Active DiseaseA Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active DiseaseSystemic Lupus Erythematosus (SLE)Drug: Acthar;Drug: Placebo for ActharMallinckrodtNot recruiting18 YearsN/ABoth36Phase 4United States
210NCT01705977November 27, 201215 July 2019Belimumab Assessment of Safety in SLEA 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 BelimumabSystemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll4019Phase 4United 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
211NCT01686555November 201216 December 2017A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)Lupus ErythematosusDrug: ABT-199;Other: PlaceboAbbVie (prior sponsor, Abbott)Not recruiting18 Years65 YearsFemale97Phase 1United States;Germany;Mexico;Puerto Rico
212EUCTR2012-002345-38-GB30/10/201230 April 2019Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus)A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS)Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE).
MedDRA version: 14.1 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xarelto
Product Name: Rivaroxaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rivaroxaban
CAS Number: 366789-02-8
Other descriptive name: Trade name Xarelto
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-20
Trade Name: The generic name is warfarin and many producers will be involved
Product Name: Warfarin
Pharmaceutical Form: Tablet
INN or Proposed INN: Warfarin
CAS Number: 81-81-2
Concentration unit: Other
University College LondonNot Recruiting Female: yes
Male: yes
156Phase 2United Kingdom
213NCT01687192October 201210 August 2015Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.Transplantation;Systemic Lupus Erythematosus;Systemic Immune DiseaseBiological: HPV prophylactic vaccine GardasilUniversity Hospital, BordeauxNot recruiting9 Years18 YearsFemale37Phase 2France
214NCT01769937October 201219 February 2015Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus ErythematosusA Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)Lupus Erythematosus Systemic ExacerbationDrug: H.P. Acthar GelFiechtner, Justus J., M.D., P.C.Not recruiting18 Years75 YearsBoth10Phase 4United States
215NCT01649765September 7, 201210 September 2018Pediatric Lupus Trial of Belimumab Plus Background Standard TherapyA 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 ErythematosusSystemic Lupus ErythematosusDrug: belimumab 10mg/kg;Other: placeboGlaxoSmithKlineHuman Genome Sciences Inc., a GSK CompanyNot recruiting5 Years17 YearsAll93Phase 2United States;Argentina;Canada;Italy;Japan;Mexico;Netherlands;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
216ChiCTR-TRC-120024192012-09-0118 April 2017The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus PatientsThe clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patientssystemic lupus erythematosus1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin;Renji Hospital, Shanghai JiaoTong University School of MedicineNot Recruiting1870Both1:60;2:60;3:60;OtherChina
217NCT01689025September 201219 February 2015An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus ErythematosusInflammation;Systemic Lupus ErythematosusDrug: NNC0114-0006;Drug: placeboNovo Nordisk A/SNot recruiting18 Years64 YearsBoth10Phase 1United States;Hungary;Poland;Serbia
218NCT01597050August 201219 October 2017Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) LesionsA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid LesionsLupus Erythematosus, Discoid;Lupus Erythematosus, SystemicDrug: R932333;Drug: PlaceboRigel PharmaceuticalsNot recruiting18 Years75 YearsAll54Phase 2United States;Canada
219NCT01532310July 16, 201215 July 2019Belimumab (BENLYSTA®) Pregnancy RegistryWEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry ProtocolSystemic Lupus ErythematosusDrug: belimumabGlaxoSmithKlinePPDRecruitingN/AN/AFemale500Phase 2United States
220NCT01892748July 201223 May 2016Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.Systemic Lupus ErythematosusDrug: Cholecalciferol;Drug: PlaceboROSA MARIA RODRIGUES PEREIRANot recruiting10 Years25 YearsFemale60N/ABrazil
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
221EUCTR2011-000368-88-GB13/06/20125 August 2014A 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 ageA 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 SLESystemic Lupus Erythematosus
MedDRA version: 17.0 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
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: belimumab
CAS Number: 356547-88-1
Current Sponsor code: GSK1550188
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes
100United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom
222NCT01597622June 11, 201222 October 2018BEL114333, 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-C1115BEL114333, 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 JapanSystemic Lupus ErythematosusDrug: BelimumabGlaxoSmithKlineHuman Genome Sciences Inc.Not recruiting18 YearsN/AAll143Phase 3Japan;Korea, Republic of
223JPRN-JapicCTI-12186401/6/20122 April 2019A Phase I study of rontalizumabA Phase I study of rontalizumabSystemic lupus erythematosus (SLE)Intervention name : Rontalizumab
Dosage And administration of the intervention : Single and multiple subcutaneous administration of 3 different doses of rontalizumab
Control intervention name : null
Chugai Pharmaceutical Co., Ltd.2064BOTH21Phase 1
224NCT01683695June 201216 December 2017Safety Study of AMG 557 in Subjects With Lupus ArthritisA Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus ArthritisLupus Arthritis, Systemic Lupus ErythematosusDrug: AMG 557;Drug: Matching PlaceboAmgenNot recruiting18 Years65 YearsAll20Phase 1United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore
225NCT01597492May 31, 201220 August 2018A 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 ErythematosusBiological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late VaccinationHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll79Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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agemin
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agemax
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PhaseCountries
226EUCTR2011-005392-16-ES23/05/201226 June 2012Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosusStudy to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients - ANAKINRA AND LUPUS ARTHRITISSystemic 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: KINERET
Product Name: KINERET
Product Code: KINERET
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Dr Josep Ordi RosAuthorisedFemale: yes
Male: yes
Spain
227NCT01687309April 30, 201211 June 2018A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and GenderA Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy SubjectsSystemic Lupus ErythematosusDrug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without foodGlaxoSmithKlineNot recruiting18 Years65 YearsAll19Phase 1Belgium
228NCT01559090April 20, 201225 March 2019Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).Systemic Lupus ErythematosusDrug: MEDI-546AstraZenecaMedImmune LLCNot recruiting18 Years65 YearsAll17Phase 2Japan
229NCT01616472April 20122 May 2016WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus CohortSystemic Lupus ErythematosusDrug: Cumulative corticosteroid exposureGlaxoSmithKlineNot recruitingN/AN/ABoth1N/A
230NCT01551069March 201219 February 2015Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin LesionA Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin LesionCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusDrug: hydroxychloroquine (Z0188);Drug: PlaceboSanofiNot recruiting18 YearsN/ABoth103Phase 3Japan
No.TrialIDDate_
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Last_Refreshed_
on
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PhaseCountries
231NCT01440231February 201219 February 2015Atacicept Demonstrating Dose RESponSeA Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Placebo;Drug: AtaciceptEMD SeronoNot recruiting18 YearsN/ABoth0Phase 2United States
232NCT01438489January 201219 October 2017A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: PlaceboMedImmune LLCNot recruiting18 Years65 YearsAll626Phase 2United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong
233NCT01488708January 201211 June 2018On Open-Label Study in Participants With Systemic Lupus ErythematosusA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNot recruiting18 YearsN/AAll1518Phase 3United States
234NCT01534403January 201216 March 2015Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) SubjectsA Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNot recruiting18 Years65 YearsBoth17Phase 2Japan
235NCT01741857January 201219 February 2015Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus ErythematosusPhase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: human umbilical cord derived MSC transplantation for SLEThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting15 Years60 YearsBoth40Phase 1/Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
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gender
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size
PhaseCountries
236NCT02021513January 201219 February 2015Pilot Study - Effect of Omega-3 on Systemic Lupus ErythematosusPilot Study - Effect of Omega-3 on Systemic Lupus ErythematosusSystemic Lupus ErythematosusDietary Supplement: Fish Oil;Dietary Supplement: Olive OilUniversity of Texas Southwestern Medical CenterNot recruiting18 Years64 YearsBoth50Phase 2United States
237NCT01516450December 26, 201116 December 2017Japanese phase1 Study of Belimumab (IV vs SC)An Open Label, Randomized, Parallel, Single Dose Study to Investigate Safety and Pharmacokinetics Following Intravenous Administration and Subcutaneous Administration of GSK1550188 in Healthy Japanese MalesSystemic Lupus ErythematosusDrug: GSK1550188 IV;Drug: GSK1550188 SCGlaxoSmithKlineNot recruiting20 Years55 YearsMale16Phase 1Japan
238NCT01405196December 20118 January 2018Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus ErythematosusA Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)Lupus Erythematosus, SystemicBiological: PF-04236921PfizerNot recruiting18 Years75 YearsAll183Phase 2United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico
239NCT01484496November 16, 201111 June 2018A 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 ErythematosusBiological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll839Phase 3United 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
240NCT01474720November 201119 February 2015Zostavax in Systemic Lupus ErythematosusImmunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Zostavax vaccineOklahoma Medical Research FoundationNot recruiting50 Years75 YearsBoth20Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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gender
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PhaseCountries
241NCT01541670November 201116 December 2017Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus NephritisA Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus NephritisSystemic Lupus ErythematosusDrug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyBaxalta now part of ShireNot recruiting18 YearsN/AAll4Phase 1United States;Australia;Canada;Mexico;New Zealand
242NCT01359826October 201128 September 2015The Effect of Milnacipran on Fatigue and Quality of Life in Lupus PatientsThe Effect of Milnacipran on Fatigue and Quality of Life in a Lupus CohortSystemic Lupus Erythematosus;Widespread Pain;FibromyalgiaDrug: MilnacipranLoma Linda UniversityForest LaboratoriesNot recruiting18 YearsN/ABoth0Phase 4United States
243NCT01449071October 201119 February 2015Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe DiseaseSystemic Lupus ErythematosusBiological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mgUCB PharmaNot recruiting18 Years64 YearsBoth20Phase 1/Phase 2Japan
244EUCTR2010-023396-25-GB22/09/201125 February 2013A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILESystemic 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: soluble Fc-gamma receptor IIb
Product Code: SM101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: .
CAS Number: .
Current Sponsor code: SM101
Other descriptive name: soluble Fc receptor
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
SuppreMol GmbHAuthorisedFemale: yes
Male: yes
50Phase 2aFrance;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
245NCT01911169June 201116 December 2017Vitamin D to Improve Endothelial Function in SLEVitamin D Repletion to Improve Endothelial Function in Lupus PatientsAtherosclerosis;Systemic Lupus ErythematosusDrug: CholecalciferolMedical University of South CarolinaNot recruiting18 Years80 YearsAll9Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2010-018563-41-BE25/05/201117 August 2015Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1Systemic Lupus Erythmatosus
MedDRA version: 17.0 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]
Product Name: Epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: CDP3194
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
UCB Inc.Not RecruitingFemale: yes
Male: yes
780Phase 3Australia;Bulgaria;Germany;Korea, Republic of;Brazil;Belgium;Mexico;Czech Republic;India;United Kingdom;Italy;Russian Federation;Israel;Lithuania;Spain;Taiwan;Estonia
247EUCTR2010-020859-30-BE25/05/20118 August 2016Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4Systemic Lupus Erythematosus
MedDRA version: 18.0 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]
Product Name: Epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: CDP3194
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
UCB Inc.Not RecruitingFemale: yes
Male: yes
1250Phase 3United States;Estonia;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
248NCT01345253May 23, 20117 October 2019GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast AsiaGSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast AsiaSystemic Lupus ErythematosusDrug: Belimumab;Drug: PlaceboGlaxoSmithKlineHuman Genome Sciences Inc.Not recruiting18 YearsN/AAll709Phase 3China;Japan;Korea, Republic of
249EUCTR2010-024131-16-DE06/05/20112 June 2014Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot StudyEfficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study - AliCLE?dult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 16.0 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Toctino®
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ALITRETINOIN
CAS Number: 5300-03-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Universitätsklinikum MünsterNot RecruitingFemale: yes
Male: yes
33Germany
250NCT01858792May 201119 February 2015A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) StudiesEfficacy 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) StudiesLupus Erythematosus, DiscoidDrug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: PlaceboHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/ABoth1N/A
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
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Target_
size
PhaseCountries
251NCT02799173April 15, 201120 August 2018Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular CalcificationDetermination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular CalcificationOsteoporosis;Lupus Erythematosus, SystemicBiological: RANKL/OPG ratio;Device: bone densitometry;Device: fan beam CT scan;Device: Doppler ultrasoundCentre Hospitalier Universitaire, AmiensNot recruiting18 Years99 YearsFemale74N/AFrance
252NCT01305746April 201119 February 2015A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)Systemic Lupus ErythematosusDrug: A-623Anthera PharmaceuticalsNot recruiting18 YearsN/ABoth382Phase 2United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan
253NCT01283139March 31, 201111 June 2018A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusA Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: PlaceboMedImmune LLCNot recruiting18 Years75 YearsAll834Phase 2United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom
254EUCTR2010-023645-29-DE15/03/201128 August 2014Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLEEfficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLEAdult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 12.1 Level: LLT Classification code 10056509 Term: Cutaneous lupus erythematosus
MedDRA version: 12.1 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus
Trade Name: Fumaderm® initial
Product Name: -
Product Code: -
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 67-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Trade Name: Fumaderm®
Product Name: -
Product Code: -
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 87-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Universitätsklinikum MünsterNot RecruitingFemale: yes
Male: yes
11Germany
255NCT03979976March 201124 June 2019Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus ErythematosusRamipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.Systemic Lupus ErythematosusDrug: RamiprilFederal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruiting18 YearsN/AFemale37Phase 2/Phase 3Brazil
No.TrialIDDate_
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PhaseCountries
256EUCTR2010-019293-32-DE10/02/201110 June 2013A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus)An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75Patients With 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: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Forigerimod
CAS Number: 1160237-55-7
Current Sponsor code: CEP-33457
Other descriptive name: IPP-201101, P140
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Cephalon, Inc.Not RecruitingFemale: yes
Male: yes
130Germany;Ukraine;Belgium;Poland;Spain;Czech Republic;Hungary;Portugal;United States
257EUCTR2010-018565-26-HU16/01/20114 August 2015Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2Systemic Lupus Erythmatosus
MedDRA version: 17.0 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]
Product Name: Epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: CDP3194
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
UCB Inc.Not RecruitingFemale: yes
Male: yes
780Phase 3Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
258NCT01205438January 201125 June 2018A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeksEli Lilly and CompanyNot recruiting18 YearsN/AAll1124Phase 3Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom;United States;Canada;Brazil;Australia
259NCT01217320January 201119 February 2015Creatine Supplementation in Pediatric RheumatologyEfficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile DermatomyositisJuvenile Systemic Lupus Erythematosus;Juvenile DermatomyositisDietary Supplement: creatine;Dietary Supplement: placebo (dextrose)University of Sao PauloRecruiting6 Years18 YearsBoth40N/ABrazil
260NCT01276782January 201121 September 2015Levothyroxine in Pregnant SLE PatientsPilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid DiseaseSystemic Lupus ErythematosusDrug: LevothyroxineJohns Hopkins UniversityNew York University School of Medicine;Duke University;University of Chicago;Stanford UniversityNot recruiting18 Years45 YearsFemale0Phase 4United States
No.TrialIDDate_
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PhaseCountries
261NCT01196091December 201025 June 2018A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: Standard of Care;Drug: Placebo every 4 weeks;Drug: Placebo every 2 weeks;Drug: LY2127399Eli Lilly and CompanyNot recruiting18 YearsN/AAll1164Phase 3United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey
262NCT01240694December 201017 September 2018A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus ErythematosusAn Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: LupuzorCephalonNot recruiting18 Years70 YearsAll136Phase 3United States;Belgium;Czechia;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom;Czech Republic
263NCT01269866December 201019 February 2015Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus ErythematosusDuloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot StudySystemic Lupus ErythematosusDrug: CymbaltaDr. Jesus Gutierrez StoneNot recruiting18 Years65 YearsBoth26N/AUnited States
264EUCTR2009-017273-38-ES26/10/201014 August 2012Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-VEstudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-VNefritis lúpico tipo III,IV y V.
MedDRA version: 9 Level: LLT Classification code 10029142 Term: Nephritis systemic lupus erythematosus
Product Name: Ciclosporina
Product Code: Csa
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORINA
CAS Number: 59865-13-3
Other descriptive name: CICLOSPORIN
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 500-
Pharmaceutical Form:
INN or Proposed INN: PREDNISONA
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Product Name: Acido Micofenolico
Product Code: ACM
Pharmaceutical Form: Tablet
INN or Proposed INN: MICOFENOLICO ACIDO
Other descriptive name: MYCOPHENOLIC ACID
Manuel Praga TerenteNot RecruitingFemale: yes
Male: yes
38Spain
265JPRN-UMIN0000041822010/10/012 April 2019efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosussystemic lupus erythematosusAdministration of TacrolimusDepartment of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesRecruiting20years-old80years-oldMale and Female30Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
266EUCTR2010-018383-16-DE17/09/201011 February 2013A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47Patients With 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: Diseases [C] - Immune System Diseases [C20]
Product Name: Lupuzor
Product Code: CEP-33457
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Forigerimod
CAS Number: 1160237-55-7
Current Sponsor code: CEP-33457
Other descriptive name: IPP-201101, P140
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Powder for injection
Route of administration of the placebo: Subcutaneous use
Cephalon, Inc.Not RecruitingFemale: yes
Male: yes
220Germany;Ukraine;Belgium;Poland;Spain;Czech Republic;Hungary;France;Portugal;United States
267NCT00979654August 201019 October 2017A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or MyositisA Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or MyositisSystemic Lupus ErythematosusDrug: SifalimumabMedImmune LLCPPDNot recruiting18 Years99 YearsAll118Phase 2United States;Brazil;Canada;Chile
268NCT01164917August 201019 February 2015Safety Study of AMG 811 in Subjects With Discoid Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus ErythematosusCutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus ErythematosusDrug: AMG811;Drug: AMG811 PlaceboAmgenNot recruiting18 Years70 YearsBoth16Phase 1United States
269NCT01381536July 20, 201016 December 2017Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: GSK1550188 1mg/kg or 10mg/kgGlaxoSmithKlineNot recruiting20 YearsN/AAll12Phase 1Japan
270NCT01085084July 20108 August 2016Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus ArthritisA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus ArthritisLupus ArthritisDrug: Laquinimod;Other: PlaceboTeva Pharmaceutical IndustriesNot recruiting18 Years75 YearsBoth82Phase 2United States;Canada
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
271NCT01162681July 201019 February 2015PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus ErythematosusA Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: A-623;Other: Placebo ComparatorAnthera PharmaceuticalsNot recruiting18 YearsN/ABoth547Phase 2United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan
272NCT01135459June 20108 August 2016A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus ErythematosusA Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Lupuzor;Drug: PlaceboCephalonNot recruiting18 Years70 YearsBoth183Phase 2Poland;Portugal;Spain;Ukraine;United Kingdom;Belgium;Czech Republic;France;Germany;Hungary;United States
273NCT01060410May 201019 February 2015Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentExploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentLupus Erythematosus, Systemic;Adverse EffectsGenetic: Polymorphism Analysis;Drug: Cyclophosphamide;Other: Pharmacokinetic analysisSun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen UniversityNot recruiting12 Years80 YearsBoth222N/AChina
274NCT01127321May 201019 October 2017A Safety and Tolerability Study of MEDI-570 in Systemic Lupus ErythematosusA Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLELupus Erythematosus, SystemicOther: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MGMedImmune LLCAstraZenecaNot recruiting18 YearsN/AAll44Phase 1United States;Canada;Mexico;Peru;South Africa
275NCT01151644April 201019 February 2015Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruitingN/AN/ABoth5000Phase 4Brazil
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
276NCT01425775April 201019 February 2015The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: vitamin D 25(OH)D;Other: PlaceboFaculty of Medicine, University of AlexandriaNot recruiting18 Years60 YearsBoth248N/AEgypt
277NCT01058343March 20101 April 2019Safety of IFNa Kinoid in Systemic Lupus ErythematosusA Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.Systemic Lupus ErythematosusBiological: IFN-KNeovacsNot recruiting18 Years50 YearsAll28Phase 1/Phase 2Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain
278NCT01093911March 201019 February 2015Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue DiseaseBiological: CDP7657;Other: PlaceboUCB PharmaNot recruiting18 Years60 YearsBoth44Phase 1Belgium;Bulgaria;Germany
279EUCTR2006-006214-16-GB23/02/201019 March 2012A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLEA randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLESystemic lupus erythematosus.
MedDRA version: 13.1 Level: LLT Classification code 10042944 Term: Systemic lupus erythematosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Crestor
Product Name: Crestor
Pharmaceutical Form: Tablet
INN or Proposed INN: ROSUVASTATIN CALCIUM
CAS Number: 147098-20-2
Other descriptive name: rosuvastatin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.07-0.14
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Crestor
Product Name: Crestor
Pharmaceutical Form: Tablet
INN or Proposed INN: ROSUVASTATIN CALCIUM
CAS Number: 147098-20-2
Other descriptive name: rosuvastatin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 13.8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Imperial CollegeAuthorisedFemale: yes
Male: yes
United Kingdom
280EUCTR2009-012059-47-BE28/01/201023 January 2017A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusA phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus ErythematosusSystemic 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
Product Name: IFN-a2b Kinoid
Product Code: IFN-K
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not assigned yet
Current Sponsor code: IFN-K DS
Other descriptive name: IFN-a 2b Kinoid Drug Substance
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 350-450
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use
Neovacs SANot RecruitingFemale: yes
Male: yes
28Phase 1;Phase 2France;Belgium;Bulgaria;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
281NCT01413230January 201019 February 2015Vitamin D Supplementation in Systemic Lupus ErythematosusEvaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus ErythematosusVitamin D DeficiencyDrug: cholecalciferolAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/ABoth20N/AFrance
282NCT01006681November 200919 February 2015Vaccination Against Influenza H1N1 in Rheumatic DiseasesEfficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory DrugsInfluenza;Rheumatic DiseasesBiological: Focetria (Monovalent MF59-Adjuvanted vaccine)Tel-Aviv Sourasky Medical CenterNot recruiting18 Years65 YearsBoth400Phase 2
283NCT01018238November 200919 February 2015An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)Inflammation;Systemic Lupus ErythematosusDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNot recruiting18 Years65 YearsBoth0Phase 1United States
284NCT01031836November 20098 August 2016A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: MEDI-545;Drug: MEDI-545 600AstraZenecaMedImmune LLCNot recruiting20 Years130 YearsBoth42Phase 2Japan
285NCT00911521October 200919 February 2015Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled StudyImmunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled StudySystemic Lupus ErythematosusDrug: human papillomavirus vaccination (Gardasil)Tuen Mun HospitalNot recruitingN/A35 YearsFemale100Phase 4China
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
286NCT00962832September 200922 August 2016A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus ErythematosusA Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Placebo;Drug: RontalizumabGenentech, Inc.Not recruiting18 Years65 YearsBoth238Phase 2United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom
287NCT01072734September 200919 February 2015Auto-immunity in Lupus Patients After Influenza VaccineRole of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine ChallengeSystemic Lupus Erythematosus (SLE)Drug: VaccineAssistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNot recruiting18 YearsN/ABoth28Phase 2France
288NCT00960362July 200919 February 2015An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus ErythematosusInflammation;Systemic Lupus Erythematosus (SLE)Drug: AGS-009;Drug: placeboArgos TherapeuticsNot recruiting18 Years65 YearsBoth13Phase 1United States;Sweden
289NCT01914770July 200919 February 2015Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76Systemic Lupus ErythematosusDrug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: PlaceboGlaxoSmithKlineHuman Genome Sciences Inc.Not recruiting18 YearsN/ABoth1016N/A
290EUCTR2009-011245-55-SE06/05/20099 September 2013An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02Systemic Lupus Erythematosus (SLE)Product Name: ABR-215757
Product Code: ABR-215757
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: paquinimod
CAS Number: 248282-01-1
Current Sponsor code: ABR-215757
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-mg milligram(s)
Active Biotech Research ABNot RecruitingFemale: yes
Male: yes
20Denmark;Sweden
No.TrialIDDate_
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291NCT00976729May 200919 February 2015NOX-E36 First-in-Human (FIH) StudyNOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy SubjectsChronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus ErythematosusDrug: NOX-E36;Drug: PlaceboNOXXON Pharma AGNot recruiting18 Years60 YearsBoth72Phase 1United Kingdom
292NCT00987831May 200919 October 2017Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)Biomarkers of Lupus Disease: Study of Biomarker Changes Before and After Treatment With Depomedrol and Background Medication Withdrawal in Patients With Mild to Moderate SLE Disease ActivitySystemic Lupus ErythematosusOther: Group B SLE one blood donation;Other: Blood drawing only Group C;Drug: Group A SLE prospective studyOklahoma Medical Research FoundationPfizerNot recruiting14 Years70 YearsAll158Phase 1/Phase 2United States
293NCT00714116March 200918 December 2018Study Evaluating The SBI-087 In Subjects With Systemic Lupus ErythematosusAn Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.Lupus Erythematosus, SystemicDrug: SBI-087PfizerEmergent Product Development Seattle LLCNot recruiting18 Years70 YearsAll30Phase 1United States;Canada
294NCT00775476March 200930 September 2019Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteineTreatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteineSystemic Lupus ErythematosusDrug: N-acetylcysteine;Drug: PlaceboState University of New York - Upstate Medical UniversityNot recruiting18 YearsN/AAll478Phase 1/Phase 2United States
295NCT00818948March 200919 February 2015Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without GlomerulonephritisA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without GlomerulonephritisNephritis;Systemic Lupus ErythematosusDrug: AMG 811AmgenNot recruiting18 Years70 YearsBoth56Phase 1United States;France;Hong Kong;Malaysia;Mexico;Singapore
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
296NCT02524795March 200924 August 2015Omega 3 Fatty Acids and Systemic Lupus ErythematosusOmega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot StudySystemic Lupus ErythematosusDietary Supplement: Hiomega-3 supplement of Naturalis® company -Federal University of Minas GeraisNot recruiting18 Years60 YearsFemale49N/A
297EUCTR2008-004852-62-IT09/02/200919 March 2012Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITISSafety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITISMedDRA version: 9.1 Level: SOC Classification code 10028395
MedDRA version: 9.1 Level: LLT Classification code 10040970
Product Name: ABETIMUS SODIUM
Product Code: LJP394
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RIQUENT
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINot RecruitingFemale: yes
Male: yes
Italy
298EUCTR2008-003833-25-DE05/02/200919 March 2012Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUSEfficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUSCutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment.
MedDRA version: 9.1 Level: LLT Classification code 10013071 Term: Discoid lupus erythematosis
MedDRA version: 9.1 Level: LLT Classification code 10057903 Term: Subacute cutaneous lupus erythematosus
MedDRA version: 9.1 Level: LLT Classification code 10056509 Term: Cutaneous lupus erythematosus
Trade Name: Raptiva
Pharmaceutical Form: Powder and solvent for solution for injection
Universitätskrankenhaus Schleswig-HolsteinNot RecruitingFemale: yes
Male: yes
17Germany
299NCT00828178February 200919 October 2017Efficacy of Fish Oil in Lupus PatientsA Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.Systemic Lupus ErythematosusDrug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starchMichelle Petri M.D.,MPHNot recruiting18 YearsN/AAll106Phase 4United States
300NCT00774943December 200819 February 2015A Study of AMG 557 in Adults With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 557AmgenNot recruiting18 Years70 YearsBoth58Phase 1United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
301NCT00710021November 200816 December 2017Vitamin D3 in Systemic Lupus ErythematosusEffect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)Systemic Lupus Erythematosus;SLE;LupusDrug: Vitamin D3;Drug: Vitamin D3 placeboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 YearsN/AAll57Phase 2United States
302NCT00752999November 200819 February 2015Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus ErythematosusA Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active DiseaseSystemic Lupus ErythematosusDrug: Fostamatinib Disodium (R935788);Drug: PlaceboRigel PharmaceuticalsNot recruiting18 YearsN/ABoth0Phase 2
303NCT00786409November 200826 February 2018Immunogenicity and Safety of HPV Vaccine Gardasil in Young WomenImmunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26Systemic Lupus ErythematosusBiological: GardasilUniversity of ChicagoMerck Sharp & Dohme Corp.Not recruiting9 Years26 YearsFemale27N/AUnited States
304NCT00732940October 200819 October 2017Phase 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 ErythematosusDrug: Belimumab 100 mg SCHuman Genome Sciences Inc.GlaxoSmithKlineNot recruiting18 YearsN/AAll56Phase 2United States;Mexico
305NCT00779194October 200824 October 2016Prospective Study of Rapamycin for the Treatment of SLEProspective Study of Rapamycin for the Treatment of SLESystemic Lupus Erythematosus (SLE)Drug: RapamycinState University of New York - Upstate Medical UniversityPfizer;PfizerNot recruiting18 YearsN/ABoth40Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
306NCT00724867August 200819 October 2017A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United StatesA 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 StatesSystemic Lupus ErythematosusBiological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kgHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll268Phase 3United States;Canada
307EUCTR2007-002589-37-GB17/07/200819 March 2012A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008systemic lupus erythematosus
MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: hLL2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
UCB IncAuthorisedFemale: yes
Male: yes
175Phase 2bHungary;United Kingdom;Belgium;Spain;Lithuania
308NCT00657189July 200815 August 2016A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With LupusA Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Systemic;LupusDrug: MEDI-545;Drug: PlaceboMedImmune LLCNot recruiting18 YearsN/ABoth87Phase 2United States
309NCT02151409June 200816 December 2017Dose-escalation Trial of Anti-C5aR Antibody in Healthy SubjectsA Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;HealthyDrug: NNC 0151-0000-0000;Drug: placeboNovo Nordisk A/SNot recruiting18 Years55 YearsMale60Phase 1Netherlands
310EUCTR2007-003621-24-FR29/05/200819 March 2012Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
MedDRA version: 9.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Aviptadil
CAS Number: 40077-57-4
Other descriptive name: VIP
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use
MondoGEN AGAuthorisedFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
311EUCTR2006-005355-16-GB07/05/200819 March 2012A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Product Name: ocrelizumab
Product Code: RO 496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche LtdNot RecruitingFemale: yes
Male: yes
423Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
312EUCTR2006-005357-29-GB07/05/20083 April 2012A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusA Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus ErythematosusLupus NephritisProduct Name: ocrelizumab
Product Code: RO 496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
F. Hoffmann-La Roche LtdAuthorisedFemale: yes
Male: yes
369Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
313NCT00508898May 200810 August 2015The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent ProteinuriaThe Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent ProteinuriaSystemic Lupus Erythematosus;Nephritis;ProteinuriaDrug: Calcitriol;Drug: MultivitaminChinese University of Hong KongNot recruiting18 Years65 YearsBoth0Phase 4Hong Kong
314NCT00611663May 200821 July 2016Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus ErythematosusVACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23®Assistance Publique - Hôpitaux de ParisNot recruiting18 Years65 YearsBoth47Phase 2/Phase 3France
315NCT00712933May 200816 December 2017A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A 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-C1057Systemic Lupus ErythematosusDrug: belimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll738Phase 3Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;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
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
316NCT00866229April 200819 February 2015Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol LevelEfficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol LevelSystemic Lupus Erythematosus;High LDL Cholesterol LevelDrug: Rosuvastatin;Drug: SimvastatinRamathibodi HospitalAstraZenecaRecruiting18 Years60 YearsBoth140Phase 4Thailand
317EUCTR2007-002566-35-GB19/03/200819 March 2012A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007systemic lupus erythematosus
MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus
Product Name: epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: CDP3194
Other descriptive name: hLL2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
UCB IncNot RecruitingFemale: yes
Male: yes
210Phase 2bHungary;United Kingdom;Belgium;Spain;Lithuania
318EUCTR2007-003698-13-GB06/03/200818 April 2012Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/IIISystemic 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]
Product Name: Atacicept
Product Code: TACI-Fc5
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Atacicept
CAS Number: 845264-92-8
Other descriptive name: TACI-Fc5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 75-150
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, GermanyAuthorisedFemale: yes
Male: yes
510Phase 2/3Germany;Malaysia;Bulgaria;France;Austria;Brazil;Australia;Czech Republic;Serbia;Peru;Korea, Republic of;Greece;Croatia;United States;Philippines;Switzerland;Netherlands;Chile;Latvia;Lithuania;Israel;India;United Kingdom;Mexico;Argentina;Taiwan;Spain;Lebanon
319NCT00626197February 200816 December 2017A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus ErythematosusLupus Nephritis;Systemic Lupus ErythematosusDrug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGNot recruiting16 YearsN/AAll381Phase 3United States
320ChiCTR-TRC-120019352008-01-1218 April 2017Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLEEffect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLEmild-to-moderate systemic lupus erythematosusTreatment Group:treated with prednisone and Jieduquyuzishen recipe;control group:treated with prednisone;Zhejinag University of Chinese MedicineNot Recruiting1860BothTreatment Group:161;control group:161;Phase 3 studyChina
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
321NCT00624338January 200819 October 2017Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo ComparatorEMD SeronoMerck KGaANot recruiting16 YearsN/AAll461Phase 2/Phase 3United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom
322NCT00539838December 200716 December 2017A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Prednisone;Drug: immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: methylprednisolone;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGNot recruiting16 YearsN/AAll33Phase 3United States
323NCT02291588December 200719 February 2015A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus ErythematosusA Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 811;Drug: PlaceboAmgenNot recruiting18 Years65 YearsBoth26Phase 1
324EUCTR2007-004635-29-SE07/11/200719 March 2012Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study.Product Name: ASF-1096 Cream 0.25%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use
Product Name: ASF-1096 Cream 0.5%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use
Product Name: ASF-1096 Cream 1.0%
Pharmaceutical Form: Cream
INN or Proposed INN: R-salbutamol sulphate
Current Sponsor code: ASF-1096
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use
Astion Pharma A/SNot RecruitingFemale: yes
Male: yes
140Denmark;Spain;Sweden
325NCT00611611October 200719 February 2015BLYS and IFN in SLEBLyS and IFN Responses to Antigen Challenge in Human SLESystemic Lupus ErythematosusBiological: fluzone;Biological: pneumovaxUniversity of Alabama at BirminghamHospital for Special Surgery, New YorkNot recruiting19 Years65 YearsBoth39N/AUnited States
No.TrialIDDate_
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326NCT00739050September 19, 200716 December 2017Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: simvastatin;Drug: Comparator: PlaceboMerck Sharp & Dohme Corp.Not recruiting18 YearsN/AFemale4Phase 4
327NCT00519363September 200719 February 2015Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like ReceptorsStatins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.Systemic Lupus ErythematosusDrug: atorvastatinThe Center for Rheumatic Disease, Allergy, & ImmunologySaint Luke's Health SystemNot recruiting18 Years60 YearsFemale15Phase 1/Phase 2United States
328EUCTR2007-004579-21-NL27/08/200719 March 2012Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?systemic lupus erythematosus (SLE) SLE is a systemic autoimmune disease.
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
Trade Name: Influvac
Pharmaceutical Form: Injection*
INN or Proposed INN: Influenz virus surface antigens
Other descriptive name: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 45-
University Medical Center GroningenAuthorisedFemale: yes
Male: yes
Netherlands
329NCT00479622August 200719 February 2015Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus ErythematosusA 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 ErythematosusSystemic Lupus ErythematosusDrug: TRU-015Wyeth is now a wholly owned subsidiary of PfizerEmergent Product Development Seattle LLCNot recruiting18 Years70 YearsBoth20Phase 1United States
330NCT00684255August 200719 October 2017Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)Systemic Lupus Erythematosus;Systemic SclerosisProcedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: CampathNew York Medical CollegeNot recruiting7 Years50 YearsAll1Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
331NCT00504244July 200719 February 2015Myfortic Versus Azathioprine in Systemic Lupus ErythematosusA Randomized, Multicenter Study to Assess the Efficacy on Diseases Activity of Enteric-coated Mycophenolate Sodium Versus Continuation of Azathioprine in Patients With Systemic Lupus Erythematosus on Azathioprine Maintenance Therapy.Systemic Lupus ErythematosusDrug: switch to Myfortic;Drug: continuation of azathioprineErasmus Medical CenterNovartis PharmaceuticalsNot recruiting18 YearsN/ABoth12Phase 3Netherlands
332NCT00413361June 200719 February 2015The Reduction of Systemic Lupus Erythematosus Flares :Study PLUSStudy of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective StudySystemic Lupus ErythematosusDrug: versus hydroxychloroquineAssistance Publique - Hôpitaux de ParisSanofi-SynthelaboNot recruiting18 YearsN/ABoth543Phase 4France
333NCT00430677June 200719 October 2017Efficacy and Safety Study of Abatacept to Treat Lupus NephritisA Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)Bristol-Myers SquibbNot recruiting18 YearsN/AAll423Phase 2/Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico
334NCT00482989June 200719 February 2015A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus ErythematosusA Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus ErythematosusLupusBiological: MEDI 545;Other: PlaceboMedImmune LLCNot recruiting18 YearsN/ABoth183Phase 1United States;Argentina;Brazil;Chile;Canada
335EUCTR2006-005177-21-GB29/05/200719 March 2012A 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-76A 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-76Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus
Product Name: belimumab
Product Code: HGS1006
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: belimumab
CAS Number: 356547-88-1
Current Sponsor code: HGS1006
Other descriptive name: LymphoStat-B TM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120 and 400-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravenous use
Human Genome Sciences, Inc.AuthorisedFemale: yes
Male: yes
810Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
336JPRN-UMIN0000007632007/05/012 April 2019Phase II study of rituximab in patients with severe systemic lupus erythematosusSystemic lupus erythematosus1000 mg of rituximab on days 1, 15, 169 and 183Zenyaku Kogyo Co., Ltd.Not Recruiting16years-old75years-oldMale and Female30Not selectedJapan
337NCT00424476May 200719 October 2017A 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 ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineNot recruiting18 YearsN/AAll865Phase 3Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China
338EUCTR2005-004575-37-FR27/04/200719 March 2012A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: CellCept
Product Name: mycophenolate mofetil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: mycophenolate mofetil
CAS Number: 24280-93-1
Current Sponsor code: MMF
Other descriptive name: CellCept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Bristol-Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes
460Phase 2/3United Kingdom;Belgium;France
339NCT00668330April 200719 February 2015Steroid Induced Osteoporosis in Patients With Systemic Lupus ErythematosusSteroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and TreatmentSystemic Lupus ErythematosusDrug: Ibandronate+alfacalcidol+calcium;Drug: placebo ibandronate+alfacalcidol+calciumChinese University of Hong KongNot recruiting18 Years80 YearsFemale40Phase 4China
340EUCTR2006-004892-36-SE15/03/200719 March 2012An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE)An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE)Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1 Level: LLT Classification code 10040967 Term: SLE
Trade Name: Subcuvia
Pharmaceutical Form: Solution for injection
Department of Rheumatology,University hospital,LundAuthorisedFemale: yes
Male: yes
Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
341JPRN-UMIN0000006392007/03/012 April 2019A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus ErythematosusSystemic lupus erythematosusIDEC-C2B8 plus oral prednisolone(tapering)
1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Placebo plus oral prednisolone(tapering)
1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Zenyaku Kogyo Co., Ltd.Not Recruiting16years-old75years-oldMale and Female150Not selectedJapan
342NCT00432354March 200719 February 2015An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: atorvastatinBuddhist Tzu Chi General HospitalPfizerRecruiting16 Years80 YearsBoth40Phase 2/Phase 3Taiwan
343NCT00698191March 200719 February 2015Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus ErythematosusRefractory Systemic Lupus ErythematosusBiological: Allogeneic MSC (AlloMSC)Nanjing Medical UniversityNational Natural Science Foundation of ChinaRecruiting15 Years70 YearsBoth20Phase 1/Phase 2China
344NCT01322308March 200719 February 2015Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus ErythematosusEffect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical TrialSystemic Lupus ErythematosusDrug: pioglitazone;Drug: placeboNational Heart Institute, MexicoNational Council of Science and Technology, Mexico;Universidad Nacional Autonoma de MexicoNot recruiting18 Years55 YearsFemale30Phase 4
345NCT01702740March 200719 February 2015A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus ErythematosusA Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus ErythematosusLupus Erythematosus, Cutaneous;Lupus Erythematosus, SystemicDrug: 1 mg/kg CNTO 136;Drug: 4 mg/kg CNTO 136;Drug: 10 mg/kg CNTO 136;Drug: PlaceboCentocor Research & Development, Inc.Not recruiting18 Years70 YearsBoth49Phase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
346NCT00541749February 200719 February 2015A Study of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusA Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: rhuMAb IFNalphaGenentech, Inc.Not recruiting18 Years65 YearsBoth60Phase 1United States
347NCT00382837January 200719 February 2015Study of Epratuzumab in Systemic Lupus ErythematosusA Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic SystemsSystemic Lupus ErythematosusDrug: EpratuzumabUCB PharmaNot recruiting18 YearsN/ABoth0Phase 3United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Italy;Netherlands;Slovakia;Spain;United Kingdom
348NCT00410384December 200619 October 2017A Study of Belimumab in Subjects With Systemic Lupus ErythematosusA 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 ErythematosusDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.GlaxoSmithKlineNot recruiting18 YearsN/AAll819Phase 3United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom
349NCT00418587December 200625 June 2018Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: CholecalciferolMedical University of South CarolinaAmerican College of Rheumatology Research and Education Foundation;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years85 YearsAll18Phase 1United States
350NCT00594932November 200619 February 2015Biomarker-Linked Outcomes of Cellcept in Lupus ArthritisBiomarker-Linked Outcomes of Cellcept in Lupus ArthritisSystemic Lupus Erythematosus;ArthritisDrug: mycophenolate mofetil;Other: placebo;Drug: Mycophenolate mofetilOklahoma Medical Research FoundationNew York University School of MedicineNot recruiting14 Years70 YearsBoth27N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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Inclusion_
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PhaseCountries
351NCT02391259November 20067 April 2015A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusRandomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 557;Drug: PlaceboAmgenNot recruiting18 Years70 YearsBoth57Phase 1United States;United Kingdom
352NCT00390091September 200614 September 2015Study of LJP 394 (Abetimus Sodium) in Lupus PatientsA Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNot recruiting12 Years70 YearsBoth0Phase 2United States
353NCT00588393September 200619 February 2015FolateScan in Autoimmune DiseaseStudy of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory DiseasesRheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus ErythematosusDrug: FolateScan (Technetium Tc 99mEC20)Mayo ClinicEndocyteNot recruiting18 YearsN/ABoth75Phase 2United States
354EUCTR2006-000674-73-HU11/08/200619 March 2012A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM, PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY AND EFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OF RENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM, PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY AND EFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OF RENAL DISEASESystemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Abetimus Sodium
CAS Number: 167362-48-3
Current Sponsor code: LJP 394
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
La Jolla Pharmaceutical CompanyAuthorisedFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
355NCT00381810June 22, 200616 December 2017A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusAn Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971gLupus Erythematosus, SystemicDrug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.Not recruiting16 Years75 YearsAll31Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
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Inclusion_
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Target_
size
PhaseCountries
356NCT00336414June 200611 June 2018Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus NephritisFive-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous CyclophosphamideSystemic Lupus Erythematosus NephritisDrug: cyclophosphamide-prednisone-azathioprineIstituto Giannina GasliniNot recruiting1 Year18 YearsAll0Phase 3Italy
357NCT00371501June 200619 February 2015Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus ErythematosusLow Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled TrialAtherosclerosis;Thromboembolism;Systemic Lupus ErythematosusDrug: Rosuvastatin;Drug: placebo;Drug: aspirinTuen Mun HospitalAstraZenecaNot recruiting18 YearsN/ABoth72Phase 4Hong Kong
358NCT00383513June 200619 February 2015Study of Epratuzumab in Systemic Lupus ErythematosusAn Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: EpratuzumabUCB PharmaNot recruiting18 YearsN/ABoth29Phase 2United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom
359NCT00556192June 200619 February 2015Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus ErythematosusCan Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?Systemic Lupus ErythematosusDrug: rituximabChinese University of Hong KongNot recruiting18 Years70 YearsBoth20Phase 2China
360EUCTR2005-004067-30-AT08/05/200619 March 2012A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisA Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisSystemic Lupus Erythematosus (SLE) with WHO Class V GlomerulonephritisTrade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Trade Name: Azathioprine
Pharmaceutical Form: Film-coated tablet
Other descriptive name: Azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Department of Rheumatology, Internal Medicine III, Medical University of ViennaNot RecruitingFemale: yes
Male: yes
44Germany;Netherlands;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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Status
Inclusion_
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Inclusion_
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PhaseCountries
361EUCTR2005-003957-28-IT02/05/20063 April 2012FIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - NDFIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - NDNew onset juvenile sistemic lupus erythematosus nephritis
MedDRA version: 6.1 Level: PT Classification code 10025140
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 2921-57-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Cyclophosphamide
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
ISTITUTO GIANNINA GASLINIAuthorisedFemale: yes
Male: yes
141Phase 2Italy
362EUCTR2005-003070-19-HU25/04/200619 March 2012A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - MylupusA randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupuslupus nephritis ( as part of the disease Systemic Lupus Erythematosus)Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080A
Pharmaceutical Form: Tablet
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
140Hungary
363JPRN-C0000001592006/03/012 April 2019Mizolibin for systemic lupus erythematosus in children(JSRDC10)systematic lupus erythematosusMethylprednisolone+mizoribine+prednisoloneJapanese Study Group of Renal Disease in Children(JSRDC)Not Recruiting2years-old18years-oldMale and Female30Not selectedJapan
364NCT00181298March 200619 February 2015Memantine in Systemic Lupus ErythematosusMemantine in Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Memantine;Drug: PlaceboJohns Hopkins UniversityForest LaboratoriesNot recruiting18 YearsN/ABoth61N/AUnited States
365NCT00299819March 200619 February 2015Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)LupusBiological: MEDI-545;Biological: MEDI 545MedImmune LLCNot recruiting18 Years80 YearsBoth45Phase 1United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
366NCT01101802March 200619 February 2015Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.Systemic Lupus Erythematosus;AtherosclerosisDrug: Mycophenolate mofetil;Drug: sugar pillGuy's and St Thomas' NHS Foundation TrustInstitute of Child Health, University College London, London, UK.Not recruiting18 Years60 YearsFemale71Phase 4United Kingdom
367NCT00297284February 200619 February 2015Memory and Attention Problems in Lupus: New Treatment Trial With ModafinilPilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE PatientsSystemic Lupus ErythematosusDrug: ModafinilHospital for Special Surgery, New YorkNot recruiting18 Years60 YearsBoth20N/AUnited States
368EUCTR2005-001391-12-GB12/10/200519 March 2012A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDEA multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDESystemic lupus erythematosus (SLE)
MedDRA version: 7.1 Level: PT Classification code 10042945
Product Name: edratide
Product Code: TV-4710
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: edratide
CAS Number: 433922-67-9
Current Sponsor code: TV-4710
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5, 1.0, 2.5-
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of administration of the placebo: Subcutaneous use
TEVA Pharmaceutical Industries, Ltd.AuthorisedFemale: yes
Male: yes
260Hungary;Germany;United Kingdom;Spain;Italy
369EUCTR2005-002207-16-GB30/09/200524 April 2012A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMADA randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMADMulti-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE)Trade Name: Myfortic
Pharmaceutical Form: Coated tablet
Trade Name: Cellcept
Pharmaceutical Form: Capsule*
Cambridge University Hospitals NHS Foundation TrustAuthorisedFemale: yes
Male: yes
40United Kingdom
370NCT00278538September 23, 200515 April 2019Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus ErythematosusCyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II TrialSystemic Lupus ErythematosusBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNot recruiting15 Years60 YearsAll33Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
371EUCTR2005-001688-74-GB22/09/200530 April 2019A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)Atherosclerosis in patients with Systemic Lupus ErythematosisTrade Name: CellCept
Product Name: Mycophenolate mofetil
Product Code: Ro 106-1443
Pharmaceutical Form: Tablet
INN or Proposed INN: Mycophenolate motetil
CAS Number: Ro 106-1443
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Guy's & St Thomas' NHS Foundation TrustNot Recruiting Female: yes
Male: no
100Phase 4United Kingdom
372NCT00119678September 200519 October 2017Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With PrednisoneA Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus FlaresSystemic Lupus ErythematosusDrug: Abatacept;Drug: Placebo;Drug: PrednisoneBristol-Myers SquibbNot recruiting18 YearsN/AAll183Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden
373NCT00230035September 200519 February 2015Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusProcedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: LeflunomideNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 Years60 YearsBoth0Phase 2United States
374NCT00203151July 200519 February 2015A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of LupusA Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: edratideTeva Pharmaceutical IndustriesNot recruiting18 Years65 YearsBoth340Phase 2United States
375EUCTR2005-000705-59-GB07/06/200524 April 2012A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE FlaresSystemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 205923-57-5
Current Sponsor code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Immunomedics, Inc.Not RecruitingFemale: yes
Male: yes
510Phase 3Hungary;Germany;United Kingdom;Spain;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
376EUCTR2004-004051-19-DE13/05/20051 May 2012A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).SYSTEMIC LUPUS ERYTHEMATOSUS, NOSProduct Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Bristol-Myers Squibb International CorporationNot RecruitingFemale: yes
Male: yes
250Phase 2BUnited Kingdom;Germany;Italy;Sweden
377EUCTR2005-000706-31-GB13/05/200529 May 2012A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLEA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLESystemic Lupus Erythematosus
Classification code 10042945
Product Name: Epratuzumab
Product Code: IMMU-103
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 205923-57-5
Current Sponsor code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Immunomedics, Inc.Not RecruitingFemale: yes
Male: yes
300Phase 3Germany;United Kingdom;Spain;Italy
378NCT00137969May 10, 200526 August 2019A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusRandomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.Not recruiting16 Years75 YearsAll262Phase 2/Phase 3United States;Canada
379NCT00583362May 1, 200516 December 2017A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02Systemic Lupus ErythematosusBiological: BelimumabHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineNot recruiting18 YearsN/AAll298Phase 2United States;Canada
380NCT02411136May 200520 April 2015A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus ErythematosusA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 623;Drug: PlaceboAmgenNot recruiting18 Years65 YearsBoth64Phase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemax
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PhaseCountries
381NCT00113971April 200519 February 2015Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: epratuzumabUCB PharmaNot recruiting18 YearsN/ABoth20Phase 2United States
382NCT00731302April 200516 December 2017Aspirin Resistance in Systemic Lupus Erythematosus (SLE)Vascular Damage in Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: aspirin and meloxicamVanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 YearsN/AAll70Phase 1United States
383EUCTR2004-004404-21-GB10/12/200421 August 2012Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in LupusOmega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in LupusSystemic Lupus ErythematosusTrade Name: Omacor
Product Name: Omacor
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Eicosapentaenoic acid
CAS Number: 25378-27-2.
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.8-
INN or Proposed INN: Docosahexaenoic acid
CAS Number: 25167-62-8
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
INN or Proposed INN: alpha-tocopherol
CAS Number: 1406-18-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
GreenPark Healthcare TrustQueens University BelfastAuthorisedFemale: yes
Male: yes
60United Kingdom
384NCT00089804October 200419 February 2015Study of LJP 394 in Lupus Patients With History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseLupus Erythematosus, Systemic;Lupus NephritisDrug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered salineLa Jolla Pharmaceutical CompanyNot recruiting12 Years70 YearsBoth943Phase 3United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro
385NCT02443506October 200425 May 2015A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus ErythematosusA Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: AMG 623;Drug: PlaceboAmgenNot recruiting18 Years55 YearsBoth56Phase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
386NCT00094380September 200416 December 2017Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA StudyLupus Erythematosus, Systemic;Lupus NephritisDrug: CTLA4-IgG4m (RG2077);Drug: CyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Not recruiting18 YearsN/AAll6Phase 1/Phase 2United States
387NCT00417430September 200419 February 2015Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular StudiesPhase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, MolecularSystemic Lupus ErythematosusDrug: ICI 182,780 (Faslodex)The Center for Rheumatic Disease, Allergy, & ImmunologyAstraZenecaNot recruiting16 Years50 YearsFemale20Phase 2United States
388NCT00278590July 200416 December 2017Allogeneic Stem Cell Transplantation in Systemic Lupus ErythematosusAllogeneic Stem Cell Transplantation in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Allogeneic Stem Cell TransplantationNorthwestern UniversityNot recruiting18 Years50 YearsAll0Phase 1United States
389NCT00076752January 30, 200416 December 2017Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus ErythematosusA Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: fludarabine phosphate;Drug: cyclophosphamide;Biological: Rituxan (rituximab);Biological: filgrastim;Drug: methylprednisolone;Other: immunologic technique;Other: laboratory biomarker analysis;Procedure: autologous hematopoietic stem cell transplantation;Drug: Diphenhydramine;Drug: MesnaNational Cancer Institute (NCI)Not recruiting15 Years40 YearsAll9Phase 2United States
390NCT00125307January 200410 August 2015Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisTacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous NephritisLupus Nephritis;Lupus Erythematosus, SystemicDrug: tacrolimusChinese University of Hong KongNot recruiting18 YearsN/ABoth20Phase 4Hong Kong;China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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Inclusion_
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size
PhaseCountries
391NCT00071487October 200319 October 2017Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicDrug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kgHuman Genome Sciences Inc.Not recruiting18 Years65 YearsAll449Phase 2United States;Canada
392NCT00189124September 200330 May 2016Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) PreventionDoes DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus?Systemic Lupus ErythematosusDrug: Dehydroepiandrosterone (DHEA)University of MichiganArthritis FoundationNot recruiting18 YearsN/AFemale13Phase 2/Phase 3United States
393NCT00082511July 200319 February 2015GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsA Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsSystemic Lupus ErythematosusDrug: Prasterone (GL701)Genelabs TechnologiesNot recruiting18 YearsN/AFemale114Phase 3United States;Mexico
394NCT00124514June 200319 February 2015Triptorelin for Ovary Protection in Childhood Onset LupusSystemic Lupus ErythematosusDrug: Triptorelin pamoateChildren's Hospital Medical Center, CincinnatiWatson PharmaceuticalsNot recruiting9 Years21 YearsFemale30Phase 2United States;Brazil
395NCT00054938March 200319 February 2015Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot StudySystemic Lupus Erythematosus;LupusDrug: pravastatin;Drug: aspirin;Drug: ramipril;Drug: Vitamins: B6, B12, and folate;Behavioral: heart health educational programBrigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/ABoth150Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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gender
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size
PhaseCountries
396NCT00637819January 200319 February 2015Leflunomide in Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)Systemic Lupus Eythematosus (SLE)Drug: LeflunomideSanofiNot recruiting18 YearsN/ABoth27Phase 2Hong Kong
397NCT00053560December 200219 February 2015To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With GlucocorticoidsA Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With GlucocorticoidsLupusDrug: Prasterone (GL701)Genelabs TechnologiesNot recruiting18 YearsN/AFemale155Phase 3United States;Mexico
398NCT00412841November 200216 December 2017Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus ErythematosusAVN Prevention With Lipitor in Lupus Erythematosus APLLE TrialAvascular NecrosisDrug: Atorvastatin;Procedure: MRI, Venipuncture;Drug: PlaceboNew York University School of MedicineNot recruiting18 Years75 YearsFemale43Phase 2United States
399NCT00046774September 2, 200211 November 2019Monoclonal Antibody Treatment for Systemic Lupus ErythematosusA Phase I, Open-Labeled, Dose-Ascending Clinical Trial of Immunotherapy of MRA, A Humanized Anti-IL 6 Receptor Monoclonal Antibody, In Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: MRA 003 USNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll23Phase 1United States
400NCT00271934September 200219 February 2015Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II StudyImmune Ablation and Hematopoietic Stem Cell Support in Patients With Poor Prognostic Indicators and Systemic Lupus Erythematosus:A Phase II StudySystemic Lupus ErythematosusBiological: Immune ablation and hematopoietic stem cell support.Richard Burt, MDNot recruitingN/A60 YearsBoth52Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
401NCT00120887April 200219 February 2015Lupus Atherosclerosis Prevention StudyLupus Atherosclerosis Prevention StudySystemic Lupus ErythematosusDrug: AtorvastatinJohns Hopkins UniversityAlliance for Lupus ResearchNot recruiting18 YearsN/ABoth200Phase 4United States
402NCT00188188March 200219 February 2015Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart DiseaseEndothelial Dysfunction in Systemic Lupus Erythematosus: Its Contribution to Abnormalities in Coronary Perfusion.Systemic Lupus ErythematosusDrug: quiniprilUniversity Health Network, TorontoHeart and Stroke Foundation of CanadaRecruiting20 YearsN/ABoth50Phase 4Canada
403NCT00293072March 200219 February 2015Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and VasculitisPilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional TherapySystemic Lupus Erythematosus;ANCA Associated VasculitisDrug: RituximabCambridge University Hospitals NHS Foundation TrustRoche Pharma AGNot recruiting18 Years70 YearsBoth20Phase 2United Kingdom
404NCT00657007February 200219 February 2015Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: belimumab;Biological: PlaceboHuman Genome Sciences Inc.Not recruiting18 YearsN/ABoth70Phase 1United States
405NCT00029926January 200219 February 2015Positron Emission Tomography (PET) to Locate Areas of White Blood Cell ActivityA Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE)Lupus Erythematosus;SystemicDrug: 2-deoxy-2 [F-18] fluoro-2-d-glucoseNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth20N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
406NCT00976300January 200219 February 2015Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudyCyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudySystemic Lupus Erythematosus;Lupus NephritisDrug: Cyclosporine A;Drug: CyclophosphamideInstitute of Rheumatology, PragueMinistry of Health, Czech Republic;Charles University, Czech Republic;Palacky University;Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic;National Institute of Rheumatology, Piestany, Slovakia;Faculty Hospital St. Anna, BrnoNot recruiting18 Years70 YearsBoth40Phase 2Czech Republic
407NCT00035308November 200119 February 2015Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney DiseaseA Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseImmunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus GlomerulonephritisDrug: Abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNot recruiting12 Years70 YearsBoth330Phase 3United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom
408NCT00017641April 200119 February 2015Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Procedure: CD34+ Peripheral Blood Stem Cell ReinfusionNorthwestern Memorial HospitalNot recruitingN/A59 YearsBoth10Phase 1United States
409NCT00011908February 200119 February 2015Humanized LL2IGG to Treat Systemic Lupus ErythematosusA Phase I Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: hLL2 (Epratuzumab)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth20Phase 1United States
410NCT00036491January 200116 December 2017Anti-CD20 in Systemic Lupus ErythematosusAn Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years70 YearsAll24Phase 1/Phase 2United States
No.TrialIDDate_
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411NCT00006133June 200019 February 2015Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: estradiol;Drug: ethinyl estradiol;Drug: medroxyprogesterone;Drug: norethindroneNational Center for Research Resources (NCRR)University of Alabama at BirminghamNot recruitingN/AN/AFemale970N/AUnited States
412NCT00391924May 200019 February 2015Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's SyndromeFatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone AdministrationLupus Erythematosus, Systemic;Sjogren's SyndromeDrug: DehydroepiandrosteroneUMC UtrechtUniversity Medical Centre Groningen;Dutch Arthritis AssociationNot recruiting18 YearsN/AFemale120Phase 2Netherlands
413NCT00006055March 200019 February 2015Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNot recruiting1 Year55 YearsBoth10N/AUnited States
414NCT00037128March 199819 February 2015Study of GL701 in Men With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: GL701Genelabs TechnologiesNot recruiting18 YearsN/AMale40Phase 3United States
415NCT00001676January 199819 February 2015Cyclophosphamide and Fludarabine to Treat Lupus NephritisCombination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte RegenerationGlomerulonephritis;Lupus Nephritis;Systemic Lupus ErythematosusDrug: SQ FludarabineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth15Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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Inclusion_
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PhaseCountries
416NCT00392093November 199719 February 2015Effect of Hormone Replacement Therapy on Lupus ActivityEffect Of Hormone Replacement Therapy On Disease Activity, Menopausal Symptoms And Bone Mineral Density In Peri/Postmenopausal Women With Systemic Lupus Erythematosus.Randomized Clinical TrialSystemic Lupus ErythematosusDrug: Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10dInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNot recruiting18 Years65 YearsFemale108Phase 4Mexico
417NCT00000421September 199711 April 2016Serologically Active, Clinically Stable Systemic Lupus ErythematosusSerologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Prednisone;Drug: PlaceboNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting13 Years65 YearsFemale154Phase 2United States
418NCT00000420June 199719 February 2015Safety of Estrogens in Lupus: Birth Control PillsSafety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral ContraceptivesSystemic Lupus ErythematosusDrug: Ortho-Novum 777New York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH)Not recruiting18 Years39 YearsFemale350Phase 3United States
419NCT00010400April 199719 February 2015Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody SyndromeSystemic Lupus Erythematosus;Antiphospholipid Antibody SyndromeDrug: Cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNot recruiting18 Years70 YearsBoth35N/AUnited States
420NCT00000419April 199619 February 2015Safety of Estrogens in Lupus: Hormone Replacement TherapySafety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement TherapySystemic Lupus ErythematosusDrug: Premarin and ProveraNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH)Not recruiting18 Years85 YearsFemale350Phase 3United States
No.TrialIDDate_
enrollement
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on
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Inclusion_
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PhaseCountries
421NCT00004662March 199619 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityNot recruiting18 YearsN/AFemale300Phase 3
422NCT00004665June 199519 February 2015Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityNot recruiting18 YearsN/AFemale20Phase 2
423NCT00470522June 199519 February 2015Study of Methotrexate in Lupus ErythematosusA Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial.Systemic Lupus ErythematosusDrug: Methotrexate and folic acidUniversity Health Network, TorontoMcGill University Health CenterNot recruiting18 YearsN/ABoth86Phase 3Canada
424JPRN-C0000003781995/03/012 April 2019A combination of methylprednisolone and prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)systematic lupus erythematosusMethylprednisolone+prednisolone
Methylprednisolone+prednisolone+mizoribine
Japanese Study Group of Renal Disease in Children(JSRDC)Not Recruiting2years-old18years-oldMale and Female60Not selectedJapan
425NCT00004643February 199519 February 2015Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: cytarabineNational Center for Research Resources (NCRR)University of MichiganNot recruiting18 Years64 YearsBoth10Phase 2
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Inclusion_
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Inclusion_
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size
PhaseCountries
426NCT00004795August 199419 February 2015Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: dehydroepiandrosteroneNational Center for Research Resources (NCRR)Northwestern UniversityNot recruiting18 YearsN/AFemale190Phase 2/Phase 3
427NCT00001212November 198619 February 2015Drug Therapy in Lupus NephropathyImmunosuppressive Drug Therapy in Membranous Lupus NephropathyNephrotic Syndrome;Systemic Lupus ErythematosusDrug: prednisone;Drug: cyclophosphamide;Drug: cyclosporin ANational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruitingN/AN/ABoth45Phase 2United States
428JPRN-JapicCTI-15306416 July 2019TULIPA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusIntervention name : anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
AstraZenecaNot Recruiting1870BOTHPhase 3
429JPRN-JapicCTI-18409516 July 2019A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA)A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA)Systemic Lupus ErythematosusIntervention name : LY3009104
INN of the intervention : Baricitinib
Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally.
Eli Lilly Japan K.K.Recruiting18BOTHPhase 3

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