56. ベーチェット病 Behcet disease Clinical trials / Disease details
臨床試験数 : 81 / 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
| 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 | NCT03371095 (ClinicalTrials.gov) | March 15, 2018 | 7/12/2017 | Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease | Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease | Behcet's Disease;Vasculitis | Drug: Infliximab;Drug: Cyclophosphamide | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 12 Years | N/A | All | 52 | Phase 3 | NULL |
| 2 | EUCTR2017-000845-39-IT (EUCTR) | 12/05/2017 | 08/06/2021 | Effectiveness of anti TNFalpha agents in Behcet¿s disease | THE ROLE OF ANTI TNF ALPHA AGENTS IN BEH¿ET¿S DISEASE REFRACTORY TO STANDARD OF CARE THERAPIES: MULTICENTER RANDOMIZED CONTROLLED PROSPECTIVE PARALLEL GROUP SINGLE-BLIND TRIAL TO EVALUATE THE 6 MONTH EFFECTIVENESS OF EITHER INFLIXIMAB OR ADALIMUMAB - FARM12LTAT | BEH¿ET¿S DISEASE REFRACTORY TO STANDARD OF CARE THERAPIES MedDRA version: 20.0;Level: LLT;Classification code 10004215;Term: Behcets disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER Product Name: HUMIRA Product Code: HUMIRA INN or Proposed INN: ADALIMUMAB Trade Name: INFLECTRA - 100 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO Product Name: INFLECTRA Product Code: INFLECTRA INN or Proposed INN: INFLIXIMAB Trade Name: MEDROL - 4 MG COMPRESSE 30 COMPRESSE Product Name: MEDROL INN or Proposed INN: METILPREDNISOLONE Trade Name: SOLU MEDROL - 500 MG/8 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE DI POLVERE DA 500 MG+ FIALA SOLVENTE DA 8 ML Product Name: SOLU MEDROL Product Code: SOLU MEDROL INN or Proposed INN: METILPREDNISOLONE SODIO SUCCINATO Trade Name: SOLU MEDROL - 40 MG/ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 40 MG/ML Product Name: SOLU MEDROL Product Code: SOLU MEDROL | AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 3 | Italy | ||
| 3 | JPRN-UMIN000025451 | 2017/04/01 | 28/12/2016 | Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease | Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease - Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease | refractory uveitis of Behcet's disease | Patients with Behcet's disease who has received Infliximab intravenous infusion treatment at 8 week intervals over a long period (over 4 years) and calm eye inflammation, shall be discontinued from infliximab and be changed to cyclosporine A oral administration. For cases in which uveitis can not be suppressed and infliximab is reintroduced, if it is 20% or less, it shall be acceptable. Cyclosporine A is started orally at 5 mg / kg / day orally twice a day from 6 weeks after the final Infiximab administration, the maintenance dose is 3 to 5 mg / kg / day, and if the clinical findings are stabilized, Losing weight little by little is judged by the research doctor . The target trough value should be less than 150 ng / ml. The observation period of cyclosporine administration is one year. | Yokohama City University Hospital | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 5 | Not selected | Japan |
| 4 | EUCTR2014-005390-36-GB (EUCTR) | 17/02/2016 | 31/12/2015 | BIO BEHCET'S TRIAL | Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment. - BIO BEHÇET’S | Behcets Disease MedDRA version: 18.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade Product Code: 3400935113276 INN or Proposed INN: infliximab Trade Name: Roferon-A, 3miu Product Name: Roferon-A 3miu Product Code: 8699505952864 INN or Proposed INN: alpha interferon Trade Name: Roferon-A, 4.5miu Product Name: Roferon-A, 4.5miu Product Code: J1081 INN or Proposed INN: alpha interferon Trade Name: Roferon-A, 6miu Product Name: Roferon-A, 6miu Product Code: 2387066 INN or Proposed INN: alpha interferon | The University of Liverpool | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United Kingdom | ||
| 5 | NCT02505568 (ClinicalTrials.gov) | July 22, 2015 | 29/6/2015 | A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease | An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subject With Moderate-to-Severe Refractory Intestinal Behcet's Disease | Behcet Disease | Drug: Infliximab | Janssen Korea, Ltd., Korea | NULL | Completed | 19 Years | 75 Years | All | 33 | Phase 3 | Korea, Republic of |
| 6 | NCT02620618 (ClinicalTrials.gov) | January 2013 | 26/11/2015 | Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study | Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study | Behçet's Disease;Uveitis | Drug: Intravitreal Infliximab | Cairo University | NULL | Completed | N/A | N/A | Both | 20 | Phase 1/Phase 2 | NULL |
| 7 | EUCTR2017-002264-41-FR (EUCTR) | 19/07/2017 | NA | Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease - ITAC | Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease MedDRA version: 20.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000017240 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg Product Name: Remicade 100 mg INN or Proposed INN: infliximab Other descriptive name: infliximab Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: cyclophosphamide Other descriptive name: cyclophosphamide | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | NA | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France |