35. 天疱瘡 Pemphigus Clinical trials / Disease details
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
| 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 | NCT04400994 (ClinicalTrials.gov) | June 20, 2020 | 27/4/2020 | IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus | The Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of Pemphigus | Pemphigus | Drug: Rituximab;Other: IVIg | The University of Hong Kong | NULL | Recruiting | 18 Years | 70 Years | All | 20 | Phase 2 | Hong Kong |
| 2 | NCT03790293 (ClinicalTrials.gov) | December 2019 | 8/10/2018 | Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial | Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment. | Autoimmune Diseases | Drug: Rituximab;Drug: corticosteroids'therapy | University Hospital, Rouen | NULL | Unknown status | 18 Years | 80 Years | All | 90 | Phase 3 | NULL |
| 3 | ChiCTR1800020382 | 2019-01-01 | 2018-12-27 | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Pemphigus | Group 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 University | NULL | Recruiting | 18 | 80 | Both | Group 1:14;Group 2:14;Group 3:14; | China | |
| 4 | EUCTR2018-001417-32-FR (EUCTR) | 13/07/2018 | 11/06/2018 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3 | Long-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 Rouen | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 3 | France | ||
| 5 | JPRN-jRCTs031180405 | 11/05/2017 | 22/03/2019 | Rituximab therapy for refractory pemphigus | Safety evaluation study about rituximab therapy for refractory pemphigus | Refactory Pemphigus Other disease of skin or skin tissue | Infuse rituximab 1000mg/body twice biweekly. | Funakoshi Takeru | NULL | Not Recruiting | >= 20age old | <= 80age old | Both | 20 | N/A | Japan |
| 6 | JPRN-UMIN000026004 | 2017/05/11 | 08/03/2017 | Safety evaluation study about rituximab therapy for refractory pemphigus | Safety evaluation study about rituximab therapy for refractory pemphigus - Rituximab therapy for refractory pemphigus | pemphigus | Infuse rituximab 1000mg/body twice biweekly | Keio University, School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 7 | JPRN-UMIN000024265 | 2016/10/04 | 04/10/2016 | 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 | 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 - 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 pemphigus | Rituximab (genetic recombination) | Department of Dermatology,Keio University School of Medicine | HOKKAIDO UNIVERSITY HOSPITALOKAYAMA UNIVERSITY HOSPITALKURUME UNIVERSITY HOSPITAL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 10 | Phase 2 | Japan |
| 8 | NCT02383589 (ClinicalTrials.gov) | May 26, 2015 | 4/3/2015 | A 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 Vulgaris | Pemphigus Vulgaris | Drug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab Placebo | Hoffmann-La Roche | Genentech, Inc. | Completed | 18 Years | 75 Years | All | 135 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine |
| 9 | EUCTR2014-000382-41-FR (EUCTR) | 02/04/2015 | 24/06/2015 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Not 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): no | United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 10 | EUCTR2014-000382-41-IT (EUCTR) | 12/03/2015 | 02/02/2015 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 11 | EUCTR2014-000382-41-ES (EUCTR) | 09/03/2015 | 22/12/2014 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Not 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): no | France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 12 | EUCTR2014-000382-41-DE (EUCTR) | 06/03/2015 | 09/12/2014 | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris | A 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 Ltd | NULL | Authorised-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): no | France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy | ||
| 13 | JPRN-UMIN000015451 | 2014/11/13 | 25/10/2014 | Exploratory 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 | Exploratory 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 - Rtx-BD Trial 2 | Pemphigus, Pemphigoid | Rituximab 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 Medicine | Hokkaido University, Kurume University, Okayama University, Kawasaki Medical School | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Phase 1,2 | Japan |
| 14 | JPRN-jRCTs031180220 | 01/05/2014 | 15/03/2019 | Rituximab treatment of blistering disease | Treatment of refractory autoimmuno blistering disease with rituximab | Pemphigus vulgaris, paraneoplastic pemphigus, bullous pemphigoid | Infusion of rituximab (1000mg) intravenously. Approximately two weeks after the first dose, a second dose of rituximab is administered in a similar manner. | Kanaoka Miwa | Michiko Aihara | Complete | >= 20age old | < 80age old | Both | 10 | N/A | Japan |
| 15 | NCT01974518 (ClinicalTrials.gov) | November 2013 | 4/10/2013 | Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus | A PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUS | Pemphigus | Drug: Rituximab and Cyclophosphamide IV | Uprety Shraddha | Postgraduate Institute of Medical Education and Research | Active, not recruiting | 18 Years | N/A | Both | 20 | Phase 3 | India |
| 16 | NCT01299857 (ClinicalTrials.gov) | June 2011 | 17/2/2011 | Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab | EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB | Pemphigus | Drug: Rituximab | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 3 | France |
| 17 | JPRN-UMIN000004428 | 2010/11/01 | 01/11/2010 | Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. | Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. - Rtx-BD Trial | pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita | Rituximab | Research group of rare intractable dermatologial disorder | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 2 | Japan |
| 18 | NCT01338103 (ClinicalTrials.gov) | January 2010 | 17/4/2011 | Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex | Treatment 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 Test | Pemphigus | Drug: Rituximab | Rabin Medical Center | Leumit Health Services | Recruiting | 18 Years | 70 Years | Both | 10 | N/A | Israel |
| 19 | NCT00784589 (ClinicalTrials.gov) | July 2009 | 3/11/2008 | Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus | Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus | Pemphigus Disease | Drug: General Corticotherapy;Drug: Rituximab | University Hospital, Rouen | NULL | Completed | 18 Years | 80 Years | All | 90 | Phase 3 | France |
| 20 | NCT00960713 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders | The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders | Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | Both | 35 | N/A | France |
| 21 | EUCTR2008-005266-31-FR (EUCTR) | 06/02/2009 | 13/03/2009 | COMPARAISON 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 | COMPARAISON 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 Rouen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 22 | NCT00656656 (ClinicalTrials.gov) | January 2008 | 7/4/2008 | Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus | Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab | Pemphigus | Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine | University of Luebeck | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | Germany |
| 23 | EUCTR2007-005711-26-IT (EUCTR) | 15/11/2007 | 05/02/2008 | An 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 | An 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 IMMACOLATA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy |