49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | 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 |
| 2 | NCT04127747 (ClinicalTrials.gov) | August 18, 2020 | 14/10/2019 | Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus | A 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 Erythematosus | Autoimmune Diseases | Drug: Standard dose of rituximab;Drug: Individualized dose of rituximab | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 18 Years | 65 Years | All | 110 | Phase 4 | China |
| 3 | NCT03747159 (ClinicalTrials.gov) | October 1, 2018 | 12/10/2018 | Synergetic 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 Erythematosus | Lupus Erythematosus, Systemic | Drug: Belimumab Injection | Leiden University Medical Center | Dutch Kidney Foundation;GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | Netherlands |
| 4 | EUCTR2018-001392-21-NL (EUCTR) | 25/09/2018 | 25/09/2018 | Synergetic 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 erythematosus | systemic lupus erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 21.1;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 Trade Name: anti-CD20 B cell depletion with Truxima Product Name: truxima | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2;Phase 3 | Netherlands | ||
| 5 | NCT03312907 (ClinicalTrials.gov) | March 1, 2018 | 13/10/2017 | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | A 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 | Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 292 | Phase 3 | United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain |
| 6 | EUCTR2016-003050-32-NL (EUCTR) | 16/02/2018 | 24/10/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A 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: 21.1;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: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 7 | EUCTR2016-003050-32-DE (EUCTR) | 09/01/2018 | 21/06/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;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: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 8 | EUCTR2016-003050-32-ES (EUCTR) | 05/12/2017 | 01/12/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A 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) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of | ||
| 9 | 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 |
| 10 | 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 |
| 11 | EUCTR2014-000488-42-NL (EUCTR) | 12/05/2014 | 09/05/2014 | Synergetic B-cell immunomodulation in SLE | The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose | Systemic 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 INN or Proposed INN: RITUXIMAB Trade Name: Benlysta Product Name: Belimumab INN or Proposed INN: BELIMUMAB | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 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 | JPRN-UMIN000000763 | 2007/05/01 | 05/07/2007 | Phase II study of rituximab in patients with severe systemic lupus erythematosus | Systemic lupus erythematosus | 1000 mg of rituximab on days 1, 15, 169 and 183 | Zenyaku Kogyo Co., Ltd. | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 30 | Phase 2 | Japan | |
| 14 | JPRN-UMIN000000639 | 2007/03/01 | 16/03/2007 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus | Systemic lupus erythematosus | IDEC-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. | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 150 | Phase 2/3 | Japan | |
| 15 | 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 |
| 16 | NCT00556192 (ClinicalTrials.gov) | June 2006 | 8/11/2007 | Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus | Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)? | Systemic Lupus Erythematosus | Drug: rituximab | Chinese University of Hong Kong | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 2 | China |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | NCT00293072 (ClinicalTrials.gov) | March 2002 | 16/2/2006 | Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis | Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy | Systemic Lupus Erythematosus;ANCA Associated Vasculitis | Drug: Rituximab | Cambridge University Hospitals NHS Foundation Trust | Roche Pharma AG | Completed | 18 Years | 70 Years | Both | 20 | Phase 2 | United Kingdom |
| 21 | NCT00036491 (ClinicalTrials.gov) | January 2001 | 10/5/2002 | Anti-CD20 in Systemic Lupus Erythematosus | An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | 70 Years | All | 24 | Phase 1/Phase 2 | United States |