49. 全身性エリテマトーデス
［臨床試験数：827，薬物数：638（DrugBank：168），標的遺伝子数：108，標的パスウェイ数：191］
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | 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 | Recruiting | 18 Years | N/A | All | 232 | N/A | Brazil |
| 2 | NCT03054259 (ClinicalTrials.gov) | September 21, 2017 | 17/1/2017 | Rituximab Objective Outcome Measures Trial in SLE | A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus | Systemic Lupus Erythematosus Arthritis | Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline | University of Leeds | NULL | Recruiting | 18 Years | 99 Years | All | 30 | Phase 2 | United Kingdom |
| 3 | ChiCTR-INR-17011495 | 2017-05-25 | 2017-05-26 | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | 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 | |||
| 4 | NCT03355482 (ClinicalTrials.gov) | April 10, 2017 | 22/11/2017 | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | Systemic Lupus Erythematosus Arthritis | Drug: Methylprednisolone;Drug: Placebos | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| 5 | 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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | 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 |
| 7 | NCT00381810 (ClinicalTrials.gov) | June 22, 2006 | 26/9/2006 | A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | An 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 U2971g | Lupus Erythematosus, Systemic | Drug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Genentech, Inc. | NULL | Terminated | 16 Years | 75 Years | All | 31 | Phase 3 | United States |
| 8 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 141 | Phase 2 | Italy | ||
| 9 | JPRN-C000000159 | 2006/03/01 | 01/04/2006 | Mizolibin for systemic lupus erythematosus in children(JSRDC10) | systematic lupus erythematosus | Methylprednisolone+mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 30 | Not selected | Japan | |
| 10 | NCT00230035 (ClinicalTrials.gov) | September 2005 | 28/9/2005 | Lupus 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 Erythematosus | Systemic Lupus Erythematosus | Procedure: 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: Leflunomide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | 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 |
| 12 | 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 | |
| 13 | JPRN-C000000378 | 1995/03/01 | 01/04/2006 | A combination of methylprednisoloneand 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 erythematosus | Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine | Japanese Study Group of Renal Disease in Children(JSRDC) | NULL | Complete: follow-up complete | 2years-old | 18years-old | Male and Female | 60 | Not selected | Japan | |
| 14 | 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 |