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 : 114 - 標的パスウェイ数 : 198

  
21 trials found
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PhaseCountries
1NCT05057481
(ClinicalTrials.gov)
September 15, 202116/9/2021Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusReappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusAutoimmune Hemolytic Anemia;Systemic Lupus ErythematosusDrug: Mycophenolate Mofetil 500mg;Drug: RituximabAssiut UniversityNULLActive, not recruiting18 YearsN/AAll30Phase 3Egypt
2NCT04127747
(ClinicalTrials.gov)
August 18, 202014/10/2019Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus ErythematosusA 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 ErythematosusAutoimmune DiseasesDrug: Standard dose of rituximab;Drug: Individualized dose of rituximabSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 Years65 YearsAll110Phase 4China
3NCT03747159
(ClinicalTrials.gov)
October 1, 201812/10/2018Synergetic 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 ErythematosusLupus Erythematosus, SystemicDrug: Belimumab InjectionLeiden University Medical CenterDutch Kidney Foundation;GlaxoSmithKlineRecruiting18 YearsN/AAll70Phase 2Netherlands
4EUCTR2018-001392-21-NL
(EUCTR)
25/09/201825/09/2018Synergetic B-cell immunomodulation in SLE – 2nd studyA 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 CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2;Phase 3Netherlands
5NCT03312907
(ClinicalTrials.gov)
March 1, 201813/10/2017A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVEA 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 ErythematosusDrug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid TaperGlaxoSmithKlineNULLCompleted18 YearsN/AAll292Phase 3United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
6EUCTR2016-003050-32-NL
(EUCTR)
16/02/201824/10/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVEA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of
7EUCTR2016-003050-32-DE
(EUCTR)
09/01/201821/06/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVEA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
8EUCTR2016-003050-32-ES
(EUCTR)
05/12/201701/12/2017A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVEA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
9NCT03054259
(ClinicalTrials.gov)
September 21, 201717/1/2017Rituximab Objective Outcome Measures Trial in SLEA Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus ErythematosusSystemic Lupus Erythematosus ArthritisDrug: Rituximab;Drug: Methylprednisolone;Drug: Normal SalineUniversity of LeedsNULLRecruiting18 Years99 YearsAll30Phase 2United Kingdom
10NCT01773616
(ClinicalTrials.gov)
April 20151/11/2012Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus NephritisPhase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus NephritisSystemic Lupus Erythematosus, Lupus NephritisDrug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisoloneImperial College LondonKarolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study GroupTerminated12 Years75 YearsAll24Phase 3United Kingdom
11EUCTR2014-000488-42-NL
(EUCTR)
12/05/201409/05/2014Synergetic 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 CenterNULLNot 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): noNetherlands
12NCT05063513
(ClinicalTrials.gov)
July 20096/5/2009Autologous Stem Cell Transplantation: International Lupus TrialRemission 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 ERYTHEMATOSUSBiological: Autologous Hematopoietic Stem Cell Transplantation;Drug: RituximabEuropean Society for Blood and Marrow TransplantationEULARWithdrawn16 Years60 YearsAll0Phase 2/Phase 3France
13JPRN-UMIN000000763
2007/05/0105/07/2007Phase II study of rituximab in patients with severe systemic lupus erythematosus Systemic lupus erythematosus1000 mg of rituximab on days 1, 15, 169 and 183Zenyaku Kogyo Co., Ltd.NULLComplete: follow-up complete16years-old75years-oldMale and Female30Phase 2Japan
14JPRN-UMIN000000639
2007/03/0116/03/2007A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus Systemic lupus erythematosusIDEC-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.NULLComplete: follow-up complete16years-old75years-oldMale and Female150Phase 2/3Japan
15NCT00381810
(ClinicalTrials.gov)
June 22, 200626/9/2006A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusAn 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 U2971gLupus Erythematosus, SystemicDrug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLTerminated16 Years75 YearsAll31Phase 3United States
16NCT00556192
(ClinicalTrials.gov)
June 20068/11/2007Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus ErythematosusCan Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?Systemic Lupus ErythematosusDrug: rituximabChinese University of Hong KongNULLCompleted18 Years70 YearsBoth20Phase 2China
17NCT00230035
(ClinicalTrials.gov)
September 200528/9/2005Lupus 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 ErythematosusSystemic Lupus ErythematosusProcedure: 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: LeflunomideNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 Years60 YearsBoth0Phase 2United States
18NCT00137969
(ClinicalTrials.gov)
May 10, 200526/8/2005A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus ErythematosusRandomized, 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 ErythematosusLupus Erythematosus, SystemicDrug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: DiphenhydramineGenentech, Inc.NULLCompleted16 Years75 YearsAll262Phase 2/Phase 3United States;Canada
19NCT00076752
(ClinicalTrials.gov)
January 30, 20042/2/2004Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus ErythematosusA Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: 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: MesnaNational Cancer Institute (NCI)NULLCompleted15 Years40 YearsAll9Phase 2United States
20NCT00293072
(ClinicalTrials.gov)
March 200216/2/2006Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and VasculitisPilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional TherapySystemic Lupus Erythematosus;ANCA Associated VasculitisDrug: RituximabCambridge University Hospitals NHS Foundation TrustRoche Pharma AGCompleted18 Years70 YearsBoth20Phase 2United Kingdom
21NCT00036491
(ClinicalTrials.gov)
January 200110/5/2002Anti-CD20 in Systemic Lupus ErythematosusAn Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 Years70 YearsAll24Phase 1/Phase 2United States