49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05666336 (ClinicalTrials.gov) | December 31, 2022 | 8/12/2022 | Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients | Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: Tacrolimus | Fen Li | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 4 | NULL |
| 2 | NCT04702256 (ClinicalTrials.gov) | December 9, 2021 | 30/11/2020 | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Lupus Nephritis;Systemic Lupus Erythematosus (SLE) | Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramine | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG | Recruiting | 14 Years | N/A | All | 196 | Phase 3 | France |
| 3 | ChiCTR2100048635 | 2021-07-19 | 2021-07-12 | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | Systemic Lupus Erythematosus | Withdrawal group:withdraw low dose prednisone;maintanence group:maintain low dose prednisone; | Peking University First Hospital | NULL | Pending | Both | Withdrawal group:92;maintanence group:92; | China | |||
| 4 | ITMCTR1900002316 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | healthy control group:nothing;control group:Prednisone acetate tablets\Hydroxychloroquine;Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | healthy control group:20;control group:20;Experimental group:20; | Phase 1 | China | ||
| 5 | ChiCTR1900022934 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | Experimental group:20;control group:20;healthy control group:20; | Phase 1 | China | ||
| 6 | NCT03804723 (ClinicalTrials.gov) | June 2019 | 11/1/2019 | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial | Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal | Drug: oral Prednisone 5mg | University of Pisa | NULL | Not yet recruiting | 18 Years | 85 Years | All | 321 | N/A | NULL |
| 7 | ChiCTR1800020286 | 2019-02-01 | 2018-12-22 | Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus | Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation | Systemic Lupus Erythematosus | Group 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 Hospital | NULL | Pending | Both | Group 2:40;Group 1:20; | I (Phase 1 study) | China | ||
| 8 | ChiCTR1800017540 | 2018-09-01 | 2018-08-03 | A 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 involvement | A 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 involvement | systemic lupus erythematosus | 1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day);2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid; | Ruijin Hospital | NULL | Completed | 18 | 65 | Both | 1:65;2:65; | Phase 4 | China |
| 9 | NCT03492255 (ClinicalTrials.gov) | April 12, 2018 | 16/3/2018 | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | Systemic Lupus Erythematosus (SLE) | Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate Mofetil | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Terminated | 18 Years | N/A | All | 49 | N/A | Brazil |
| 10 | NCT03098823 (ClinicalTrials.gov) | September 12, 2017 | 21/3/2017 | A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE | A 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 Erythematosus | Lupus Erythematosus, Systemic;Lupus Erythematosus;Fatigue | Drug: RAYOS;Drug: Prednisone | Ampel BioSolutions, LLC | NULL | Completed | 18 Years | 99 Years | All | 62 | Phase 4 | United States |
| 11 | ChiCTR-INR-17011495 | 2017-05-25 | 2017-05-26 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic sy | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | Primary mild to moderate systemic systemic lupus erythematosus | Immunomodulatory 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 Technology | NULL | Recruiting | Both | Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30; | China | |||
| 12 | NCT02558517 (ClinicalTrials.gov) | January 2014 | 22/9/2015 | Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus | Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus | Systemic Lupus Erythematosus | Drug: prednisone discontinuation | Groupe Hospitalier Pitie-Salpetriere | NULL | Recruiting | 18 Years | 75 Years | Both | 136 | Phase 3 | France |
| 13 | NCT01946880 (ClinicalTrials.gov) | November 20, 2013 | 13/9/2013 | Randomized 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;SLE | Drug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: Prednisone | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Terminated | 18 Years | 70 Years | All | 102 | Phase 2 | United States |
| 14 | EUCTR2009-017273-38-ES (EUCTR) | 26/10/2010 | 27/07/2010 | Estudio 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-V | Estudio 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-V | Nefritis 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 INN or Proposed INN: CICLOSPORINA Other descriptive name: CICLOSPORIN INN or Proposed INN: PREDNISONA Other descriptive name: PREDNISONE Product Name: Acido Micofenolico Product Code: ACM INN or Proposed INN: MICOFENOLICO ACIDO Other descriptive name: MYCOPHENOLIC ACID | Manuel Praga Terente | NULL | Not Recruiting | Female: yes Male: yes | 38 | Spain | |||
| 15 | ChiCTR-TRC-12001935 | 2008-01-12 | 2012-02-12 | Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE | Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE | mild-to-moderate systemic lupus erythematosus | Treatment Group:treated with prednisone and Jieduquyuzishen recipe;control group:treated with prednisone; | Zhejinag University of Chinese Medicine | NULL | Completed | 18 | 60 | Both | Treatment Group:161;control group:161; | 3 (Phase 3 study) | China |
| 16 | NCT00539838 (ClinicalTrials.gov) | December 19, 2007 | 3/10/2007 | A 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 Erythematosus | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 16 Years | N/A | All | 33 | Phase 3 | United States |
| 17 | NCT00430677 (ClinicalTrials.gov) | June 2007 | 1/2/2007 | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis | A 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 Erythematosus | Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 423 | Phase 2/Phase 3 | United 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 |
| 18 | EUCTR2006-002107-13-IT (EUCTR) | 24/11/2006 | 09/03/2007 | A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND | A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND | Systemic lupus erythematosis MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Trade Name: MYFORTIC*50CPR RIV 360MG INN or Proposed INN: Mycophenolic acid Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: MYFORTIC*50CPR RIV 360MG INN or Proposed INN: Mycophenolic acid Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;United Kingdom;France;Spain;Italy;Greece | |||
| 19 | NCT00336414 (ClinicalTrials.gov) | June 2006 | 12/6/2006 | Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis | Five-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 Cyclophosphamide | Systemic Lupus Erythematosus Nephritis | Drug: cyclophosphamide-prednisone-azathioprine | Istituto Giannina Gaslini | NULL | Withdrawn | 1 Year | 18 Years | All | 0 | Phase 3 | Italy |
| 20 | EUCTR2005-003957-28-IT (EUCTR) | 02/05/2006 | 09/05/2006 | FIVE-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. - ND | FIVE-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. - ND | New onset juvenile sistemic lupus erythematosus nephritis MedDRA version: 6.1;Level: PT;Classification code 10025140 | INN or Proposed INN: Azathioprine INN or Proposed INN: Methylprednisolone INN or Proposed INN: Prednisone INN or Proposed INN: Cyclophosphamide INN or Proposed INN: Cyclophosphamide | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | 141 | Phase 3 | Belgium;Denmark;Italy | ||
| 21 | NCT00119678 (ClinicalTrials.gov) | September 2005 | 30/6/2005 | Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone | A 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 Flares | Systemic Lupus Erythematosus | Drug: Abatacept;Drug: Placebo;Drug: Prednisone | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 183 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden |
| 22 | NCT00137969 (ClinicalTrials.gov) | May 10, 2005 | 26/8/2005 | A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | Randomized, 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 Erythematosus | Lupus Erythematosus, Systemic | Drug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: Diphenhydramine | Genentech, Inc. | NULL | Completed | 16 Years | 75 Years | All | 262 | Phase 2/Phase 3 | United States;Canada |
| 23 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, 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 Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 24 | NCT00000421 (ClinicalTrials.gov) | September 1997 | 3/11/1999 | Serologically Active, Clinically Stable Systemic Lupus Erythematosus | Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Placebo | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 13 Years | 65 Years | Female | 154 | Phase 2 | United States |
| 25 | NCT00001212 (ClinicalTrials.gov) | November 1986 | 3/11/1999 | Drug Therapy in Lupus Nephropathy | Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy | Nephrotic Syndrome;Systemic Lupus Erythematosus | Drug: prednisone;Drug: cyclophosphamide;Drug: cyclosporin A | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | N/A | Both | 45 | Phase 2 | United States |
| 26 | EUCTR2017-002050-36-FR (EUCTR) | 03/11/2017 | Personalised approach to the tapering of corticosteroid treatment in systemic lupus patients | Personalised pharmacological approach to the tapering of corticosteroid doses in systemic lupus patients treated with prednisone - DECOR | Systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Prednisone | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | NA | Female: yes Male: yes | 120 | Phase 4 | France |