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 | NCT05767047 (ClinicalTrials.gov) | March 10, 2023 | 8/3/2023 | A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis | Behçet's Disease;Juvenile Psoriatic Arthritis | Drug: Apremilast | Amgen | NULL | Not yet recruiting | 5 Years | 18 Years | All | 48 | Phase 3 | NULL |
| 2 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis | Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG 407 INN or Proposed INN: Apremilast | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland | ||
| 3 | NCT05683626 (ClinicalTrials.gov) | December 15, 2022 | 4/1/2023 | Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital | Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital | Uveitis | Drug: Humira | Sohag University | NULL | Recruiting | 18 Years | 40 Years | All | 40 | Egypt | |
| 4 | ChiCTR2100052808 | 2022-01-01 | 2021-11-05 | Mechanism of neutrophils activating cGAS-STING pathway through NETs to activate NLRP3 and promote macrophage pyrosis to promote behcet disease progression | Mechanism of neutrophils activating cGAS-STING pathway through NETs to activate NLRP3 and promote macrophage pyrosis to promote behcet disease progression | Behcet's disease | Control group:No;Active period Behcet's disease(BD) group:No;Remission period BD group:No; | Huadong Hospital of Fudan University | NULL | Recruiting | 18 | 55 | Both | Control group:20;Active period Behcet's disease(BD) group:20;Remission period BD group:20; | China | |
| 5 | NCT04528082 (ClinicalTrials.gov) | September 9, 2021 | 24/8/2020 | Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN) | Behçet Disease | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Recruiting | 2 Years | 17 Years | All | 60 | Phase 3 | France;Greece;Israel;Italy;Spain;Switzerland;United Kingdom |
| 6 | EUCTR2019-002787-27-IT (EUCTR) | 24/05/2021 | 07/06/2021 | Apremilast study in children with active oral ulcers associated with Behçet's Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled,Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN) - BEAN | Subjects with active Behçet's Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast Product Code: [AMG 407] INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: [AMG407] INN or Proposed INN: Apremilast | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Israel;Netherlands;Switzerland;Italy | ||
| 7 | EUCTR2019-002787-27-GR (EUCTR) | 20/05/2021 | 07/05/2021 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Israel;Netherlands;Switzerland | ||
| 8 | ChiCTR2100045463 | 2021-05-01 | 2021-04-15 | Efficacy and safety of Adalimumab in refractory intestinal Behcet’s disease: A single-center, interventional, open-label, single-arm study | Efficacy and safety of Adalimumab in refractory intestinal Behcet’s disease: A single-center, interventional, open-label, single-arm study | intestinal Beh?et's disease | One-armed intervention group:adalimumab; | The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Recruiting | 18 | 70 | Both | One-armed intervention group:30; | Phase 4 | China |
| 9 | ChiCTR2100044593 | 2021-03-15 | 2021-03-24 | Clinical study of endoscopic treatment for Patients with intestinal Behcet's disease having poor response to conventional treatment | Clinical study of endoscopic treatment for Patients with intestinal Behcet's disease having poor response to conventional treatment | intestinal Behcet's disease | Single group:Endoscopic injection of triamcinolone acetonide; | The First Affiliated Hospital of Sun Yat-Sen University | ,NULL | Recruiting | 16 | 70 | Both | Single group:30; | China | |
| 10 | ChiCTR2000037172 | 2021-01-01 | 2020-08-27 | Randomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's Disease | Randomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's Disease | Behcet's Disease | experimental group:Shen's Qinlian Soil Fuling Granules + Thalidomide Tablets;control group:placebo + Thalidomide Tablets ; | Shanghai Traditional Chinese Medicine Hospital | NULL | Pending | 16 | 70 | Both | experimental group:60;control group:60; | China | |
| 11 | ITMCTR2000003766 | 2021-01-01 | 2020-08-27 | Randomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's Disease | Randomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's Disease | Behcet's Disease | experimental group:Shen's Qinlian Soil Fuling Granules + Thalidomide Tablets;control group:placebo + Thalidomide Tablets ; | Shanghai Traditional Chinese Medicine Hospital | NULL | Pending | 16 | 70 | Both | experimental group:60;control group:60; | China | |
| 12 | NCT04609397 (ClinicalTrials.gov) | November 30, 2020 | 19/10/2020 | A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease | A Phase ? Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease | Behçet Disease | Drug: Hemay005;Other: Placebo | Tianjin Hemay Pharmaceutical Co., Ltd | NULL | Terminated | 18 Years | 75 Years | All | 89 | Phase 2 | China |
| 13 | NCT04334031 (ClinicalTrials.gov) | July 20, 2020 | 10/3/2020 | Deployment o the Multidisciplinary Prospective Cohort Imminent | Deployment o the Multidisciplinary Prospective Cohort Imminent | Chronic Inflammatory Disease;Angioedema;Severe Asthma;Lupus;Atopic Dermatitis;Psoriatic Arthritis;Multiple Sclerosis;Systemic Sclerosis;Behçet Disease | Genetic: Biobanking with genetic analysis;Other: SF-12 questionnaire | University Hospital, Lille | FHU IMMINeNT;FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs;Fond de dotation de la Société Française de Dermatologie (SFD) | Recruiting | 18 Years | N/A | All | 2200 | N/A | France |
| 14 | ChiCTR2000031637 | 2020-04-10 | 1990-01-01 | Behcet’s Uveitis Therapy (BUT) Study | Behcet’s Uveitis Therapy (BUT) Study | Uveitis in Behcet’s Disease | Arm A: Interferon Alpha-2a;Arm B:Adalimumab;Arm C:Cyclosporine; | The First Affiliated Hospital of Chongqing Medical University | NULL | Pending | Both | Arm A:90;Arm B:90;Arm C:90; | Phase 4 | China | ||
| 15 | NCT04218565 (ClinicalTrials.gov) | February 15, 2020 | 8/12/2019 | Golimumab for the Treatment of Refractory Behcet's Uveitis | Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease | Behcet Syndrome;Uveitis | Biological: Golimumab (GOL) | Wenjie Zheng | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 2 | China |
| 16 | NCT04186559 (ClinicalTrials.gov) | February 2020 | 2/12/2019 | Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers | Clinical Protocol to Evaluate Use of Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers | Behcet Syndrome;Behcet Disease | Drug: Topical Pentoxifylline Gel (Vehicle +PTX);Drug: Topical Placebo Gel (Vehicle) | Silk Road Therapies, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 17 | ChiCTR1900027147 | 2020-01-01 | 2019-11-02 | Efficacy and safety of adalimumab in Behcet's disease-related uveitis | Efficacy and safety of adalimumab in Behcet's disease-related uveitis | Behcet's disease-related uveitis | 1:Adalimumab; | State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University | NULL | Pending | Both | 1:30; | Phase 4 | China | ||
| 18 | NCT04065672 (ClinicalTrials.gov) | November 12, 2019 | 20/8/2019 | Low-dose IL-2 Treatment on Behcet's Disease | Low-dose IL-2 Treatment on Behcet's Disease | Behcet's Disease | Drug: Low-dose IL-2 | Peking University People's Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 15 | Phase 2 | China |
| 19 | NCT03771768 (ClinicalTrials.gov) | May 25, 2019 | 1/12/2018 | Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease | Active Control,Randomized,Double- Blinded Clinical Trial of BD | Autoimmune;Behcet Syndrome | Radiation: Diode laser 980nm&100 mWatt;Drug: Triamcinolone Acetonide | Cairo University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 38 | N/A | NULL |
| 20 | NCT05032248 (ClinicalTrials.gov) | April 1, 2019 | 27/8/2021 | Uses of Tacrolimus in Behcet Disease | Uses of Tacrolimus in Treatment of Oral Ulcers in Behcet Disease | Oral Ulcer;Behcet Syndrome | Drug: Tacrolimus ointment | Assiut University | NULL | Completed | 18 Years | 70 Years | All | 40 | N/A | Egypt |
| 21 | NCT03888846 (ClinicalTrials.gov) | March 25, 2019 | 21/3/2019 | Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers | Clinical Protocol for Administration of Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers | Behçet Disease Affecting Oral Mucosa | Drug: Pentoxifylline;Drug: Colchicine | Ipekyolu Ilac Ltd. Sti | Istanbul University-Cerrahpasa School of Medicine | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Turkey |
| 22 | NCT04022421 (ClinicalTrials.gov) | October 1, 2018 | 15/7/2019 | Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis | The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention | Behcet's Syndrome, Vascular Type | Drug: Hydroxychloroquine | Assiut University | NULL | Recruiting | 18 Years | N/A | All | 50 | N/A | Egypt |
| 23 | NCT03522662 (ClinicalTrials.gov) | August 1, 2018 | 1/5/2018 | Anti IL-18 (GSK1070806) in Behcet's Disease | An Experimental Medicine Study to Characterise the Importance of IL-18 Production and to Evaluate the Therapeutic Potential of IL-18 Blockade With GSK1070806 in Subjects With Behcet's Disease | Behcet's Disease | Drug: GSK1070806 | Cambridge University Hospitals NHS Foundation Trust | NULL | Unknown status | 18 Years | N/A | All | 12 | Phase 2 | United Kingdom |
| 24 | NCT03554161 (ClinicalTrials.gov) | May 10, 2018 | 21/4/2018 | Tocilizumab for the Treatment of Refractory Behcet's Uveitis | Efficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease | Behcet Syndrome;Uveitis | Biological: Tocilizumab (TCZ) | Wenjie Zheng | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 2 | China |
| 25 | 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 |
| 26 | NCT03209219 (ClinicalTrials.gov) | June 30, 2017 | 4/7/2017 | Interferon a2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis | Randomized Prospective Comparative Study of Interferon a2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis | Behçet Disease;Uveitis | Drug: Interferon Alfa-2A;Drug: Cyclosporine Pill | Peking Union Medical College Hospital | NULL | Completed | 18 Years | 65 Years | All | 28 | Phase 3 | China |
| 27 | NCT02648581 (ClinicalTrials.gov) | June 14, 2017 | 21/12/2015 | Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease | A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease | Behçet Disease | Drug: Subcutaneous Ustekinumab | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | France |
| 28 | 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 | ||
| 29 | 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 |
| 30 | EUCTR2014-002108-25-GR (EUCTR) | 06/07/2016 | 08/06/2016 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 19.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 31 | NCT02756650 (ClinicalTrials.gov) | June 23, 2016 | 31/3/2016 | 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement | An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular Involvement | Behcet Disease | Drug: Canakinumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 60 Years | All | 8 | Phase 2 | Turkey |
| 32 | JPRN-UMIN000020029 | 2016/04/01 | 01/12/2015 | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation | Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies. | Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more. | Saitama Medical University | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 300 | Not selected | Japan |
| 33 | 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 | ||
| 34 | EUCTR2015-002190-37-FR (EUCTR) | 30/10/2015 | 12/01/2016 | A Study to Evaluate the Efficacy and Safety of Ustekinumab in patients with Behçet disease | A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in patients with Behçet disease : STELABEC - STELABEC | Behçet diseaseSTELABEC-1: patients with oral ulcersSTELABEC-2 : patients with active posterior uveitis or panuveitis 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: STELARA Product Name: STELARA INN or Proposed INN: Ustekinumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France | ||
| 35 | 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 |
| 36 | EUCTR2014-002108-25-DE (EUCTR) | 17/06/2015 | 25/11/2014 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Trade Name: Otezla Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 37 | EUCTR2014-002108-25-IT (EUCTR) | 24/02/2015 | 13/05/2015 | Study to test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of active Behçet’s disease (oral ulcers). This study also tests how well the body tolerates apremilast. The study is conducted in several centers in different countries. | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHÇET’S DISEASE - NA | SUBJECTS WITH ACTIVE BEHÇET’S DISEASE MedDRA version: 18.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of | ||
| 38 | NCT02307513 (ClinicalTrials.gov) | December 30, 2014 | 2/12/2014 | A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease | A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease | Behçet's Syndrome | Drug: Apremilast;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 207 | Phase 3 | United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey |
| 39 | NCT02258867 (ClinicalTrials.gov) | November 2014 | 2/10/2014 | Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis | A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis | Behcet's Disease Uveitis | Drug: Placebo;Drug: Gevokizumab | XOMA (US) LLC | NULL | Terminated | 18 Years | N/A | Both | 4 | Phase 3 | United States |
| 40 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 41 | JPRN-UMIN000012469 | 2013/12/02 | 02/12/2013 | Comparison of Adalimumab and Steroid in Intestinal Behcet's disease | Comparison of Adalimumab and Steroid in Intestinal Behcet's disease - Castle Study | Intestinal Behcet's disease | Subcutaneous injection of adalumumab with 160mg at 0 week, 80mg at 2 weeks and 40mg every other week after at 4 weeks continuously. Oral administration of prednisolone with 0.6mg/kg/day during from 1 to 2 weeks, and tapering off until 12 weeks with decreasing dosage 5mg/kg/week approximately | Castle Study Group | NULL | Recruiting | 15years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 42 | EUCTR2012-001125-27-GB (EUCTR) | 15/01/2013 | 12/09/2012 | Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitisEYEGUARD TM -B | Behçet’s disease uveitis MedDRA version: 18.0;Level: LLT;Classification code 10071139;Term: Behcet's uveitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Portugal;Hong Kong;Saudi Arabia;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of | ||
| 43 | EUCTR2012-001125-27-PT (EUCTR) | 04/01/2013 | 13/09/2012 | Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis - EYEGUARD TM-B | Behçet’s disease uveitis MedDRA version: 18.0;Level: LLT;Classification code 10071139;Term: Behcet's uveitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 3 | Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of | ||
| 44 | 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 |
| 45 | EUCTR2012-001125-27-IT (EUCTR) | 26/11/2012 | 21/09/2012 | Efficacy of gevokizumab in the treatment of patients with Behcet`s disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis. The EYEGUARD B study. - THE EYEGUARD TM B STUDY | Behçet's disease uveitis MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: GEVOKIZUMAB Product Code: S78989 INN or Proposed INN: GEVOKIZUMAB Other descriptive name: XOMA 052 | INSTITUT DE RECHERCHES INTERNATIONALES SERVIER | NULL | Not Recruiting | Female: yes Male: yes | 110 | Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;Brazil;Tunisia;Germany;China;Korea, Republic of | |||
| 46 | NCT01965145 (ClinicalTrials.gov) | November 2012 | 17/9/2013 | Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B) | A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis | Behcet's Uveitis | Drug: Gevokizumab;Drug: Placebo | Institut de Recherches Internationales Servier | NULL | Terminated | 18 Years | N/A | All | 84 | Phase 3 | Korea, Republic of;United Kingdom |
| 47 | EUCTR2012-001125-27-ES (EUCTR) | 17/10/2012 | 02/10/2012 | Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet?s Disease uveitis | Behçet?s disease uveitis MedDRA version: 14.1;Level: LLT;Classification code 10071139;Term: Behcet's uveitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Laboratorios Servier S.L. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of | |||
| 48 | EUCTR2012-001125-27-GR (EUCTR) | 03/10/2012 | 13/09/2012 | Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis | Behçet’s disease uveitis MedDRA version: 15.0;Level: LLT;Classification code 10071139;Term: Behcet's uveitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 110 | Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of | |||
| 49 | EUCTR2012-001125-27-DE (EUCTR) | 24/09/2012 | 12/09/2012 | Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis | A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitisEYEGUARD TM -B | Behçet’s disease uveitis MedDRA version: 17.1;Level: LLT;Classification code 10071139;Term: Behcet's uveitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 44 | Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Germany;Tunisia;China;Korea, Republic of | |||
| 50 | NCT01532570 (ClinicalTrials.gov) | January 2012 | 6/2/2012 | Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions | To Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Patients With Behcet's Disease ( BD ) With Special Lesions After the Administration of TA-650 | Behcet's Disease;Behcet Syndrome;Neuro-Behcet's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 16 Years | 75 Years | All | 18 | Phase 3 | Japan |
| 51 | EUCTR2010-024152-29-DE (EUCTR) | 02/09/2011 | 21/06/2011 | An open-label study to evaluate efficacy and tolerability of Canakinumab in patients with Behçet Disease who do not respond to standard treatment (Eine offene Studie zur Wirksamkeit und Verträglichkeit von Canakinumab bei Patienten mit Morbus Behçet, die auf die übliche Behandlung nicht ansprechen) | Canakinumab for Behçet`s Disease Resistant to Standard Treatment(CanBeDisT) - CanBeDisT | Behçet`s Disease MedDRA version: 14.0;Level: PT;Classification code 10004213;Term: Behcet's syndrome;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Ilaris Product Name: Ilaris INN or Proposed INN: CANAKINUMAB | University Hospital of Tübingen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Germany | |||
| 52 | NCT01441076 (ClinicalTrials.gov) | September 2011 | 24/9/2011 | Anakinra for Behcet s Disease | A Pilot Study of Anakinra in Behcet's Disease (BD) | Autoimmune Connective Tissue Disorder;Immune System Diseases | Drug: Anakinra | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | 18 Years | 65 Years | All | 6 | Phase 1/Phase 2 | United States |
| 53 | NCT00931957 (ClinicalTrials.gov) | October 2010 | 30/6/2009 | Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease | Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease | Behcet Syndrome;Uveal Disease | Drug: Etanercept, Methotrexate, Prednisolone | Tehran University of Medical Sciences | Wyeth is now a wholly owned subsidiary of Pfizer | Recruiting | 16 Years | 60 Years | Both | 80 | N/A | Iran, Islamic Republic of |
| 54 | NCT01243671 (ClinicalTrials.gov) | October 2010 | 17/11/2010 | A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease | A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease | Intestinal Behçet's Disease | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | Eisai Co., Ltd. | Completed | 15 Years | N/A | All | 20 | Phase 3 | Japan |
| 55 | NCT01211977 (ClinicalTrials.gov) | August 27, 2010 | 29/9/2010 | A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and Behcet's Disease | A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome (FCAS) / Muckle-Wells Syndrome (MWS) and Behcet's Disease (BD) | Muckle Wells Syndrome;Autoinflammatory;Behcet's Disease | Drug: XOMA 052 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States |
| 56 | EUCTR2009-013901-33-DE (EUCTR) | 21/06/2010 | 03/03/2010 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303E1, SHIELD Study | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303E1, SHIELD Study | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | France;Greece;Spain;Austria;Germany | |||
| 57 | EUCTR2009-013901-33-GR (EUCTR) | 15/06/2010 | 22/02/2011 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Germany;France;Spain;Greece;Austria | |||
| 58 | NCT04328064 (ClinicalTrials.gov) | May 2010 | 29/8/2011 | The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease | Behcet's Disease | Drug: Rosuvastatin calcium 40mg;Drug: Placebo oral tablet | University of Alexandria | NULL | Completed | 17 Years | 65 Years | All | 56 | N/A | NULL | |
| 59 | EUCTR2009-013901-33-FR (EUCTR) | 07/04/2010 | 16/02/2010 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | Adjunctive therapy to standard-of-care for the treatment of intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis MedDRA version: 12.1;Classification code 10022557;Term: Intermediate uveitis MedDRA version: 12.1;Classification code 10033687;Term: Panuveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | France;Greece;Spain;Austria;Germany | |||
| 60 | EUCTR2009-013901-33-ES (EUCTR) | 18/02/2010 | 18/01/2010 | Extensión de 38 semanas del estudio aleatorizado multicéntrico con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveítis posterior o panuveítis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base - C2303E1 | Extensión de 38 semanas del estudio aleatorizado multicéntrico con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveítis posterior o panuveítis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base - C2303E1 | terapia adyuvante de los agentes inmunosupresores de base para el tratamiento de la uveítis posterior o de la panuveítis secundaria a la enfermedad de Behçet MedDRA version: 9;Level: LLT;Classification code 10004212;Term: Behcet's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: AIN457 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 159 | Germany;France;Spain;Greece;Austria | |||
| 61 | NCT01306955 (ClinicalTrials.gov) | February 2010 | 1/3/2011 | The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease | The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study | Behcet's Disease | Drug: methylorednisolone;Other: dextrose water 5% | Tehran University of Medical Sciences | NULL | Recruiting | 10 Years | 70 Years | Both | 34 | Phase 4 | Iran, Islamic Republic of |
| 62 | EUCTR2009-011237-27-DE (EUCTR) | 17/11/2009 | 06/08/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria | |||
| 63 | EUCTR2009-013901-33-AT (EUCTR) | 12/11/2009 | 13/10/2009 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Germany;France;Spain;Greece;Austria | |||
| 64 | EUCTR2009-011237-27-FR (EUCTR) | 23/10/2009 | 06/08/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10033687;Term: Panuveitis MedDRA version: 12.0;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: Not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 102 | France;Hungary;Greece;Spain;Austria;Germany;Italy | |||
| 65 | EUCTR2009-011237-27-ES (EUCTR) | 20/10/2009 | 05/08/2009 | Estudio aleatorizado multicéntrico, con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveitis posterior o panuveitis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base. - C2303 | Estudio aleatorizado multicéntrico, con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveitis posterior o panuveitis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base. - C2303 | Tratamiento de uveítis posterior o panuveítis secundaria a Behçet de forma aditiva al tratamiento inmunosupresor de base MedDRA version: 9;Level: LLT;Classification code 10004212;Term: Behcet's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: AIN457 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Hungary;Greece;Spain;Austria;Germany;Italy | ||
| 66 | EUCTR2009-011237-27-HU (EUCTR) | 15/10/2009 | 29/07/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 112 | France;Hungary;Greece;Spain;Austria;Germany;Italy | |||
| 67 | EUCTR2009-011237-27-AT (EUCTR) | 14/10/2009 | 18/09/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria | |||
| 68 | NCT00995709 (ClinicalTrials.gov) | October 2009 | 13/10/2009 | Phase III Study in Refractory Behcet's Disease | A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet¿s Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy | Behcet Disease | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 118 | Phase 3 | United States;Egypt;France;Germany;Greece;Hong Kong;India;Israel;Italy;Jordan;Korea, Republic of;Singapore;Spain;Switzerland;Taiwan;Tunisia;Turkey;Austria;Brazil;Hungary;Saudi Arabia |
| 69 | EUCTR2009-011237-27-GR (EUCTR) | 22/09/2009 | 07/10/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria | |||
| 70 | NCT00866359 (ClinicalTrials.gov) | August 1, 2009 | 18/3/2009 | A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease | Behcet Syndrome | Drug: Apremilast (CC-10004);Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 111 | Phase 2 | United States;Turkey |
| 71 | NCT00720928 (ClinicalTrials.gov) | July 2008 | 18/7/2008 | Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease | A Multi-Center, Prospective Single Arm Study to Assess the Efficacy and Safety of RETISERT (Intravitreal Flucinolone Acetonide 0.59mg) in Patients With Refractory Ocular Behcet's Disease | Ocular Behcet's Disease,;Non-Infectious Uveitis;Refractory Uveitis | Drug: flucinolone acetonide | Asan Medical Center | Samsung Medical Center;Seoul National University Hospital;Kyunghee University Medical Center | Recruiting | 18 Years | N/A | Both | 15 | Phase 4 | Korea, Republic of |
| 72 | NCT00550498 (ClinicalTrials.gov) | December 2007 | 27/10/2007 | Stem Cell Transplantation in Ocular Lesions of Behcet's Disease | Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease | Retinitis;Behcet's Syndrome | Biological: Autologous Stem Cell Transplantation | Tehran University of Medical Sciences | NULL | Terminated | 16 Years | N/A | Both | 5 | Phase 1 | Iran, Islamic Republic of |
| 73 | NCT00483184 (ClinicalTrials.gov) | April 2006 | 5/6/2007 | Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease | Phase II Study, Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçet's Disease | Behcet Syndrome;Behcet Disease;Mucocutaneous Ulceration | Biological: Veldona, | Nobel Pharmaceuticals | Amarillo Biosciences, Inc. | Completed | 18 Years | 75 Years | All | 84 | Phase 2 | Turkey |
| 74 | NCT00664599 (ClinicalTrials.gov) | April 2006 | 20/4/2008 | Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease | Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study) | Behcet's Syndrome | Drug: Rituximab;Drug: Cytotoxic Combination | Tehran University of Medical Sciences | Hoffmann-La Roche | Completed | 16 Years | N/A | Both | 20 | Phase 2 | Iran, Islamic Republic of |
| 75 | NCT00167583 (ClinicalTrials.gov) | November 2004 | 9/9/2005 | Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB) | Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcet's Disease - a National,Randomised, Single-masked Controlled Trial (INCYTOB) | Behcet's Disease;Panuveitis;Posterior Uveitis;Retinal Vasculitis | Drug: Cyclosporin A;Drug: Interferon-alpha2a | University Hospital Tuebingen | NULL | Completed | 18 Years | 75 Years | All | 37 | Phase 3 | Germany |
| 76 | NCT00278512 (ClinicalTrials.gov) | August 2003 | 15/1/2006 | Hematopoietic Stem Cell Support in Vasculitis | High Dose Immune Suppression With Hematopoietic Stem Cell Support in Refractory Vasculitis, Necrotizing Vasculitis, Neurovascular Behcet's Disease, and Sjogren's Syndrome | Vasculitis | Biological: Autologous Stem Cell Transplant;Biological: Allogeneic Stem Cell Transplant | Northwestern University | NULL | Terminated | 16 Years | 60 Years | Both | 7 | Phase 1 | United States |
| 77 | NCT00700297 (ClinicalTrials.gov) | August 2002 | 17/6/2008 | Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease | A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease | Behcet's Syndrome | Drug: Colchicine;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 14 Years | 60 Years | Both | 169 | Phase 2 | Iran, Islamic Republic of |
| 78 | NCT00001865 (ClinicalTrials.gov) | July 1999 | 3/11/1999 | HAT in Eye Complications of Behcet's Disease | A Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcet's Disease | Behcet's Syndrome;Retinal Disease;Uveitis | Drug: Daclizumab | National Eye Institute (NEI) | NULL | Completed | N/A | N/A | Both | 26 | Phase 2 | United States |
| 79 | EUCTR2019-002787-27-FR (EUCTR) | 18/12/2020 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Israel;Netherlands;Switzerland | |||
| 80 | EUCTR2019-002787-27-NL (EUCTR) | 11/02/2021 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy | |||
| 81 | 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 |