35. 天疱瘡 Pemphigus Clinical trials / Disease details


臨床試験数 : 98 薬物数 : 126 - (DrugBank : 41) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 168

  
23 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04400994
(ClinicalTrials.gov)
June 20, 202027/4/2020IVIG With Rituximab vs Rituximab as First Line Treatment of PemphigusThe Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of PemphigusPemphigusDrug: Rituximab;Other: IVIgThe University of Hong KongNULLRecruiting18 Years70 YearsAll20Phase 2Hong Kong
2NCT03790293
(ClinicalTrials.gov)
December 20198/10/2018Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 TrialClinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment.Autoimmune DiseasesDrug: Rituximab;Drug: corticosteroids'therapyUniversity Hospital, RouenNULLUnknown status18 Years80 YearsAll90Phase 3NULL
3ChiCTR1800020382
2019-01-012018-12-27Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigusEfficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus PemphigusGroup 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy;Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy;Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone);West China Hospital, Sichuna UniversityNULLRecruiting1880BothGroup 1:14;Group 2:14;Group 3:14;China
4EUCTR2018-001417-32-FR
(EUCTR)
13/07/201811/06/2018Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation Patients with Bullous pemphigoid included in RITUXIMAB3 study
MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA
INN or Proposed INN: RITUXIMAB
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
CHU-Hôpitaux de RouenNULLNot RecruitingFemale: yes
Male: yes
77Phase 3France
5JPRN-jRCTs031180405
11/05/201722/03/2019Rituximab therapy for refractory pemphigusSafety evaluation study about rituximab therapy for refractory pemphigus Refactory Pemphigus
Other disease of skin or skin tissue
Infuse rituximab 1000mg/body twice biweekly.Funakoshi TakeruNULLNot Recruiting>= 20age old<= 80age oldBoth20N/AJapan
6JPRN-UMIN000026004
2017/05/1108/03/2017Safety evaluation study about rituximab therapy for refractory pemphigusSafety evaluation study about rituximab therapy for refractory pemphigus - Rituximab therapy for refractory pemphigus pemphigusInfuse rituximab 1000mg/body twice biweeklyKeio University, School of MedicineNULLRecruiting20years-old80years-oldMale and Female20Not applicableJapan
7JPRN-UMIN000024265
2016/10/0404/10/2016Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigusOpen-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus - Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus steroid treatment-resistant pemphigusRituximab (genetic recombination)Department of Dermatology,Keio University School of MedicineHOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITALComplete: follow-up complete20years-old80years-oldMale and Female10Phase 2Japan
8NCT02383589
(ClinicalTrials.gov)
May 26, 20154/3/2015A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisPemphigus VulgarisDrug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab PlaceboHoffmann-La RocheGenentech, Inc.Completed18 Years75 YearsAll135Phase 3United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
9EUCTR2014-000382-41-FR
(EUCTR)
02/04/201524/06/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
10EUCTR2014-000382-41-IT
(EUCTR)
12/03/201502/02/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
124Phase 3United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
11EUCTR2014-000382-41-ES
(EUCTR)
09/03/201522/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
12EUCTR2014-000382-41-DE
(EUCTR)
06/03/201509/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
13JPRN-UMIN000015451
2014/11/1325/10/2014Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin.Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2 Pemphigus, PemphigoidRituximab 375mg/sqm, q1w, 4 doses.
Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48
Department of Dermatology,Keio University School of MedicineHokkaido University, Kurume University, Okayama University, Kawasaki Medical SchoolComplete: follow-up complete20years-old80years-oldMale and Female20Phase 1,2Japan
14JPRN-jRCTs031180220
01/05/201415/03/2019Rituximab treatment of blistering diseaseTreatment of refractory autoimmuno blistering disease with rituximab Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoidInfusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner.Kanaoka MiwaMichiko AiharaNot Recruiting>= 20age old< 80age oldBoth10N/AJapan
15NCT01974518
(ClinicalTrials.gov)
November 20134/10/2013Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe PemphigusA PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUSPemphigusDrug: Rituximab and Cyclophosphamide IVUprety ShraddhaPostgraduate Institute of Medical Education and ResearchActive, not recruiting18 YearsN/ABoth20Phase 3India
16NCT01299857
(ClinicalTrials.gov)
June 201117/2/2011Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by RituximabEVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMABPemphigusDrug: RituximabUniversity Hospital, RouenNULLCompleted18 YearsN/ABoth22Phase 3France
17JPRN-UMIN000004428
2010/11/0101/11/2010Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. pemphigus, bullous pemphigoid, epidermolysis bullosa acquisitaRituximabResearch group of rare intractable dermatologial disorderNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 2Japan
18NCT01338103
(ClinicalTrials.gov)
January 201017/4/2011Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via CylexTreatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex TestPemphigusDrug: RituximabRabin Medical CenterLeumit Health ServicesRecruiting18 Years70 YearsBoth10N/AIsrael
19NCT00784589
(ClinicalTrials.gov)
July 20093/11/2008Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With PemphigusComparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With PemphigusPemphigus DiseaseDrug: General Corticotherapy;Drug: RituximabUniversity Hospital, RouenNULLCompleted18 Years80 YearsAll90Phase 3France
20NCT00960713
(ClinicalTrials.gov)
June 200916/7/2009The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune DisordersThe RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune DisordersPemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;CryoglobulinemiaDrug: Rituximab (MABTHERA® or RITUXAN®).University Hospital, ToulouseNULLCompleted18 YearsN/ABoth35N/AFrance
21EUCTR2008-005266-31-FR
(EUCTR)
06/02/200913/03/2009COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab IIICOMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III Pemphogoide bulleuse
MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid
Trade Name: mabthéra
Product Name: mathéra
Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
CHU-Hôpitaux de RouenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
22NCT00656656
(ClinicalTrials.gov)
January 20087/4/2008Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for PemphigusCombined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and RituximabPemphigusDrug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus AzathioprineUniversity of LuebeckNULLCompleted18 YearsN/AAll23Phase 2Germany
23EUCTR2007-005711-26-IT
(EUCTR)
15/11/200705/02/2008An open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - NDAn open prospective, monocenter, consecutive non randomized clinical trial on therapy with monoclonal antibodies anti-CD20 in the treatment of pemphigus vulgare or foliaceus, serious and resistant to common therapies - ND Pemphigus vulgaris, pemphigus foliaceus
MedDRA version: 9.1;Level: LLT;Classification code 10034280;Term: Pemphigus
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
ISTITUTO DERMOPATICO IMMACOLATANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy