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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 | ||||
| 8 | 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 | ||||
| 9 | NCT00213512 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | Effect of Anti CD20 in Pemphigus Desease | Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera). | Pemphigus | Drug: Mabthera | University Hospital, Rouen | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 2/Phase 3 | France |