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 | NCT05306873 (ClinicalTrials.gov) | October 28, 2022 | 11/3/2022 | Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus | A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10) | Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil;Drug: Placebo for Mycophenolate Mofetil;Drug: Voclosporin;Drug: Placebo for Voclosporin | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 18 Years | 60 Years | All | 120 | Phase 2 | United States |
| 3 | 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 |
| 4 | NCT05057481 (ClinicalTrials.gov) | September 15, 2021 | 16/9/2021 | Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Autoimmune Hemolytic Anemia;Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil 500mg;Drug: Rituximab | Assiut University | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 5 | 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 |
| 6 | 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 |
| 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 | JPRN-UMIN000025328 | 2015/12/05 | 25/12/2016 | A 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 Nephritis | A 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 Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis | systemic lupus erythematosus | Tacrolimus Mycophenolate Mofetil | The University of Hong Kong | NULL | Recruiting | 18years-old | 75years-old | Male and Female | 200 | Not selected | Japan,Asia(except Japan) |
| 9 | NCT01773616 (ClinicalTrials.gov) | April 2015 | 1/11/2012 | Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis | Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis | Systemic Lupus Erythematosus, Lupus Nephritis | Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone | Imperial College London | Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group | Terminated | 12 Years | 75 Years | All | 24 | Phase 3 | United Kingdom |
| 10 | 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 |
| 11 | NCT01085097 (ClinicalTrials.gov) | September 1, 2010 | 4/3/2010 | A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) | Lupus Nephritis | Drug: Laquinimod;Drug: Mycophenolate Mofetil;Drug: Prednisolone/Prednisone;Drug: Placebo;Drug: Methylprednisolone | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 75 Years | All | 46 | Phase 2 | United States;Canada;France;Russian Federation;United Kingdom |
| 12 | NCT05063513 (ClinicalTrials.gov) | July 2009 | 6/5/2009 | Autologous Stem Cell Transplantation: International Lupus Trial | Remission Induction Therapy for Refractory Systemic Lupus Erythematosus With Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Versus Rituximab (antiCD20) Followed by Maintenance Therapy With Mycophenolate Mofetil (MMF) | REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS | Biological: Autologous Hematopoietic Stem Cell Transplantation;Drug: Rituximab | European Society for Blood and Marrow Transplantation | EULAR | Withdrawn | 16 Years | 60 Years | All | 0 | Phase 2/Phase 3 | France |
| 13 | EUCTR2005-004575-37-GB (EUCTR) | 14/03/2008 | 08/10/2008 | 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). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | 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). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 14 | 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 |
| 15 | 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 |
| 16 | EUCTR2005-004575-37-BE (EUCTR) | 21/11/2007 | 15/06/2007 | 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).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | 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).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 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 | EUCTR2005-004575-37-FR (EUCTR) | 27/04/2007 | 26/03/2007 | 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). | 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 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2;Phase 3 | France;Belgium;United Kingdom | ||
| 19 | NCT00594932 (ClinicalTrials.gov) | November 2006 | 4/1/2008 | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Systemic Lupus Erythematosus;Arthritis | Drug: mycophenolate mofetil;Other: placebo | Oklahoma Medical Research Foundation | NYU Langone Health | Completed | 14 Years | 70 Years | All | 27 | Phase 1/Phase 2 | United States |
| 20 | NCT01101802 (ClinicalTrials.gov) | March 2006 | 9/4/2010 | Mycophenolate 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;Atherosclerosis | Drug: Mycophenolate mofetil;Drug: sugar pill | Guy's and St Thomas' NHS Foundation Trust | Institute of Child Health, University College London, London, UK. | Completed | 18 Years | 60 Years | Female | 71 | Phase 4 | United Kingdom |
| 21 | EUCTR2005-002207-16-GB (EUCTR) | 30/09/2005 | 16/08/2005 | A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD | A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD | Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE) | Trade Name: Myfortic Trade Name: Cellcept | Cambridge University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 22 | EUCTR2005-001688-74-GB (EUCTR) | 22/09/2005 | 16/08/2005 | 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) | 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 Erythematosis | Trade Name: CellCept Product Name: Mycophenolate mofetil Product Code: Ro 106-1443 INN or Proposed INN: Mycophenolate motetil | Guy's & St Thomas' NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: no | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |