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 | ITMCTR2100005063 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | A prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | Systemic lupus erythematosus | Experimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide); | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Female | Experimental group:264;Control Group:264; | N/A | China |
| 3 | ChiCTR2100048796 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | A prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus | Systemic lupus erythematosus | Experimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide); | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Female | Experimental group:264;Control Group:264; | N/A | China |
| 4 | ChiCTR2200055471 | 2021-01-01 | 2022-01-10 | Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus: a medical record-based study | Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus | Systemic Lupus Erythematosus (SLE) | belimumab group:Low-dose cyclophosphamide combined with belimumab;cyclophosphamide group:Standard dose cyclophosphamide; | The Second Hospital of Shanxi Medical University | NULL | Recruiting | 18 | 80 | Both | belimumab group:40;cyclophosphamide group:42; | China | |
| 5 | 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 |
| 6 | NCT03030976 (ClinicalTrials.gov) | March 2017 | 22/1/2017 | A 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 cells | Shanghai GeneChem Co., Ltd. | RenJi Hospital | Recruiting | 18 Years | 69 Years | All | 5 | Phase 1 | China |
| 7 | NCT02080195 (ClinicalTrials.gov) | September 13, 2016 | 28/2/2014 | Nonmyeloablative 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 SLE | Lupus Erythematosus;Graft-versus-host Disease | Drug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplant | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Stem Cell Research Fund | Terminated | 18 Years | 75 Years | All | 1 | Phase 1/Phase 2 | United States |
| 8 | ChiCTR-ONC-15007547 | 2015-12-05 | 2015-12-04 | Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study | Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus | systemic lupus erythematosus | The 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 University | NULL | Recruiting | 18 | 60 | Both | The combination of Chinese and western group:264;Treating by Western Medicine group:264; | China | |
| 9 | NCT02444728 (ClinicalTrials.gov) | July 2015 | 12/5/2015 | Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE | Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus | Thrombocytopenia | Drug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: Methylprednisolone | Chinese SLE Treatment And Research Group | Peking Union Medical College Hospital | Recruiting | 18 Years | 70 Years | All | 220 | Phase 3 | China |
| 10 | NCT01689350 (ClinicalTrials.gov) | October 2012 | 17/9/2012 | A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Prospective Study Based on Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Systemic Lupus Erythematosus | Genetic: Genotype Detection | Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University | Completed | 12 Years | 60 Years | All | 92 | N/A | China |
| 11 | NCT01060410 (ClinicalTrials.gov) | May 2010 | 1/2/2010 | Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Lupus Erythematosus, Systemic;Adverse Effects | Genetic: Polymorphism Analysis;Drug: Cyclophosphamide;Other: Pharmacokinetic analysis | Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University | Completed | 12 Years | 80 Years | Both | 222 | N/A | China |
| 12 | NCT00626197 (ClinicalTrials.gov) | February 2008 | 20/2/2008 | A 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 Erythematosus | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 16 Years | N/A | All | 381 | Phase 3 | United States |
| 13 | EUCTR2005-003957-28-DK (EUCTR) | 21/12/2006 | 20/11/2006 | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDE | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDE | SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS MedDRA version: 8.1;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus | Product Name: Cyclophosphamide Product Name: Cyclophosphamide | Istituto Giannina Gaslini | NULL | Not Recruiting | Female: yes Male: yes | 141 | Phase 3 | Denmark;Italy | ||
| 14 | 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 |
| 15 | 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 | ||
| 16 | NCT00278538 (ClinicalTrials.gov) | September 23, 2005 | 15/1/2006 | Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus | Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial | Systemic Lupus Erythematosus | Biological: Hematopoietic stem cell transplantation | Northwestern University | NULL | Completed | 15 Years | 60 Years | All | 32 | Phase 2 | United States |
| 17 | NCT00094380 (ClinicalTrials.gov) | September 2004 | 16/10/2004 | Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) | Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA Study | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: CTLA4-IgG4m (RG2077);Drug: Cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States |
| 18 | NCT00076752 (ClinicalTrials.gov) | January 30, 2004 | 2/2/2004 | Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus | A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: 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: Mesna | National Cancer Institute (NCI) | NULL | Completed | 15 Years | 40 Years | All | 9 | Phase 2 | United States |
| 19 | NCT00976300 (ClinicalTrials.gov) | January 2002 | 11/9/2009 | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Systemic Lupus Erythematosus;Lupus Nephritis | Drug: Cyclosporine A;Drug: Cyclophosphamide | Institute of Rheumatology, Prague | Ministry 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, Brno | Completed | 18 Years | 70 Years | Both | 40 | Phase 2 | Czech Republic |
| 20 | NCT00017641 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion | Northwestern Memorial Hospital | NULL | Active, not recruiting | N/A | 59 Years | Both | 10 | Phase 1 | United States | |
| 21 | 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 | |
| 22 | NCT00001676 (ClinicalTrials.gov) | January 1998 | 3/11/1999 | Cyclophosphamide and Fludarabine to Treat Lupus Nephritis | Combination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte Regeneration | Glomerulonephritis;Lupus Nephritis;Systemic Lupus Erythematosus | Drug: SQ Fludarabine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | N/A | N/A | Both | 15 | Phase 1 | United States |
| 23 | NCT00010400 (ClinicalTrials.gov) | April 1997 | 2/2/2001 | Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome | Systemic Lupus Erythematosus;Antiphospholipid Antibody Syndrome | Drug: Cyclophosphamide;Drug: filgrastim | Johns Hopkins University | NULL | Completed | 18 Years | 70 Years | Both | 35 | N/A | United States | |
| 24 | 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 |
| 25 | EUCTR2005-003957-28-BE (EUCTR) | 24/10/2006 | 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 - PRINTO JSLE Trial | 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 - PRINTO JSLE Trial | Systemic lupus erythematosus nephritis | Product Name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide | University Hospital Gent | NULL | NA | Female: yes Male: yes | 216 | Phase 3 | Belgium;Denmark;Italy |