56. ベーチェット病 Behcet disease Clinical trials / Disease details


臨床試験数 : 76 薬物数 : 110 - (DrugBank : 32) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04528082
(ClinicalTrials.gov)
September 9, 202124/8/2020Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's DiseaseA 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 DiseaseDrug: Apremilast;Drug: PlaceboAmgenNULLRecruiting2 Years17 YearsAll60Phase 3France;Greece;Israel;Italy;Spain;Switzerland;United Kingdom
2EUCTR2019-002787-27-IT
(EUCTR)
24/05/202107/06/2021Apremilast study in children with active oral ulcers associated with Behçet's DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland;Italy
3EUCTR2019-002787-27-GR
(EUCTR)
20/05/202107/05/2021Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Greece;Israel;Netherlands;Switzerland
4ChiCTR2100045463
2021-05-012021-04-15Efficacy and safety of Adalimumab in refractory intestinal Behcet’s disease: A single-center, interventional, open-label, single-arm studyEfficacy and safety of Adalimumab in refractory intestinal Behcet’s disease: A single-center, interventional, open-label, single-arm study intestinal Beh?et's diseaseOne-armed intervention group:adalimumab;The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLRecruiting1870BothOne-armed intervention group:30;Phase 4China
5ChiCTR2100044593
2021-03-152021-03-24Clinical study of endoscopic treatment for Patients with intestinal Behcet's disease having poor response to conventional treatmentClinical study of endoscopic treatment for Patients with intestinal Behcet's disease having poor response to conventional treatment intestinal Behcet's diseaseSingle group:Endoscopic injection of triamcinolone acetonide;The First Affiliated Hospital of Sun Yat-Sen University,NULLRecruiting1670BothSingle group:30;China
6ChiCTR2000037172
2021-01-012020-08-27Randomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's DiseaseRandomized Double-blind Controlled Study of Shenshi Shengdiqinlian Tufuling Decoction in the Treatment of Mucocutaneous Behcet's Disease Behcet's Diseaseexperimental group:Shen's Qinlian Soil Fuling Granules + Thalidomide Tablets;control group:placebo + Thalidomide Tablets ;Shanghai Traditional Chinese Medicine HospitalNULLPending1670Bothexperimental group:60;control group:60;China
7NCT04609397
(ClinicalTrials.gov)
November 30, 202019/10/2020A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet DiseaseA Phase ? Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet DiseaseBehçet DiseaseDrug: Hemay005;Other: PlaceboTianjin Hemay Pharmaceutical Co.,LtdNULLRecruiting18 Years75 YearsAll252Phase 2China
8ChiCTR2000031637
2020-04-101990-01-01Behcet’s Uveitis Therapy (BUT) StudyBehcet’s Uveitis Therapy (BUT) Study Uveitis in Behcet’s DiseaseArm A: Interferon Alpha-2a;Arm B:Adalimumab;Arm C:Cyclosporine;The First Affiliated Hospital of Chongqing Medical UniversityNULLPendingBothArm A:90;Arm B:90;Arm C:90;Phase 4China
9NCT04218565
(ClinicalTrials.gov)
February 15, 20208/12/2019Golimumab for the Treatment of Refractory Behcet's UveitisEfficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's DiseaseBehcet Syndrome;UveitisBiological: Golimumab (GOL)Wenjie ZhengNULLRecruiting18 Years65 YearsAll9Phase 2China
10NCT04186559
(ClinicalTrials.gov)
February 20202/12/2019Topical Pentoxifylline Gel on Behcet's Disease Genital UlcersClinical Protocol to Evaluate Use of Topical Pentoxifylline Gel on Behcet's Disease Genital UlcersBehcet Syndrome;Behcet DiseaseDrug: Topical Pentoxifylline Gel (Vehicle +PTX);Drug: Topical Placebo Gel (Vehicle)Silk Road Therapies, Inc.NULLNot yet recruiting18 YearsN/AAll60Phase 2United States
11ChiCTR1900027147
2020-01-012019-11-02Efficacy and safety of adalimumab in Behcet's disease-related uveitisEfficacy and safety of adalimumab in Behcet's disease-related uveitis Behcet's disease-related uveitis1:Adalimumab;State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen UniversityNULLPendingBoth1:30;Phase 4China
12NCT04065672
(ClinicalTrials.gov)
November 12, 201920/8/2019Low-dose IL-2 Treatment on Behcet's DiseaseLow-dose IL-2 Treatment on Behcet's DiseaseBehcet's DiseaseDrug: Low-dose IL-2Peking University People's HospitalNULLRecruiting18 Years70 YearsAll15Phase 2China
13NCT03771768
(ClinicalTrials.gov)
May 25, 20191/12/2018Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's DiseaseActive Control,Randomized,Double- Blinded Clinical Trial of BDAutoimmune;Behcet SyndromeRadiation: Diode laser 980nm&100 mWatt;Drug: Triamcinolone AcetonideCairo UniversityNULLNot yet recruiting18 Years60 YearsAll38N/ANULL
14NCT05032248
(ClinicalTrials.gov)
April 1, 201927/8/2021Uses of Tacrolimus in Behcet DiseaseUses of Tacrolimus in Treatment of Oral Ulcers in Behcet DiseaseOral Ulcer;Behcet SyndromeDrug: Tacrolimus ointmentAssiut UniversityNULLCompleted18 Years70 YearsAll40N/AEgypt
15NCT03888846
(ClinicalTrials.gov)
March 25, 201921/3/2019Topical Pentoxifylline Gel on Behcet's Disease Oral UlcersClinical Protocol for Administration of Topical Pentoxifylline Gel on Behcet's Disease Oral UlcersBehçet Disease Affecting Oral MucosaDrug: Pentoxifylline;Drug: ColchicineIpekyolu Ilac Ltd. StiIstanbul University-Cerrahpasa School of MedicineRecruiting18 YearsN/AAll60Phase 2Turkey
16NCT04022421
(ClinicalTrials.gov)
October 1, 201815/7/2019Hydroxychloroquine Efficacy on Behcet's Disease ThrombosisThe Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events PreventionBehcet's Syndrome, Vascular TypeDrug: HydroxychloroquineAssiut UniversityNULLRecruiting18 YearsN/AAll50N/AEgypt
17NCT03522662
(ClinicalTrials.gov)
August 1, 20181/5/2018Anti IL-18 (GSK1070806) in Behcet's DiseaseAn 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 DiseaseBehcet's DiseaseDrug: GSK1070806Cambridge University Hospitals NHS Foundation TrustNULLUnknown status18 YearsN/AAll12Phase 2United Kingdom
18NCT03554161
(ClinicalTrials.gov)
May 10, 201821/4/2018Tocilizumab for the Treatment of Refractory Behcet's UveitisEfficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's DiseaseBehcet Syndrome;UveitisBiological: Tocilizumab (TCZ)Wenjie ZhengNULLTerminated18 Years65 YearsAll3Phase 2China
19NCT03371095
(ClinicalTrials.gov)
March 15, 20187/12/2017Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet DiseaseMulticenter, 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 DiseaseBehcet's Disease;VasculitisDrug: Infliximab;Drug: CyclophosphamideAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting12 YearsN/AAll52Phase 3NULL
20NCT03209219
(ClinicalTrials.gov)
June 30, 20174/7/2017Interferon a2a Versus Cyclosporine for Refractory Behçet's Disease UveitisRandomized Prospective Comparative Study of Interferon a2a and Cyclosporine in Patients With Refractory Behçet's Disease UveitisBehçet Disease;UveitisDrug: Interferon Alfa-2A;Drug: Cyclosporine PillPeking Union Medical College HospitalNULLCompleted18 Years65 YearsAll28Phase 3China
21NCT02648581
(ClinicalTrials.gov)
June 14, 201721/12/2015Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet DiseaseA 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 DiseaseBehçet DiseaseDrug: Subcutaneous UstekinumabAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll16Phase 2France
22EUCTR2017-000845-39-IT
(EUCTR)
12/05/201708/06/2021Effectiveness of anti TNFalpha agents in Behcet¿s diseaseTHE 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 PISANANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 3Italy
23JPRN-UMIN000025451
2017/04/0128/12/2016Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's diseaseClinical 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 diseasePatients 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 HospitalNULLComplete: follow-up complete20years-old65years-oldMale and Female5Not selectedJapan
24EUCTR2014-002108-25-GR
(EUCTR)
06/07/201608/06/2016Study 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
25NCT02756650
(ClinicalTrials.gov)
June 23, 201631/3/20161 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular InvolvementAn Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular InvolvementBehcet DiseaseDrug: CanakinumabNovartis PharmaceuticalsNULLCompleted18 Years60 YearsAll8Phase 2Turkey
26JPRN-UMIN000020029
2016/04/0101/12/2015The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infectionThe 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 UniversityNULLRecruiting16years-oldNot applicableMale and Female300Not selectedJapan
27EUCTR2014-005390-36-GB
(EUCTR)
17/02/201631/12/2015BIO BEHCET'S TRIALOptimal 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 LiverpoolNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United Kingdom
28EUCTR2015-002190-37-FR
(EUCTR)
30/10/201512/01/2016A Study to Evaluate the Efficacy and Safety of Ustekinumab in patients with Behçet diseaseA 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)NULLNot RecruitingFemale: yes
Male: yes
30Phase 2France
29NCT02505568
(ClinicalTrials.gov)
July 22, 201529/6/2015A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's DiseaseAn Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subject With Moderate-to-Severe Refractory Intestinal Behcet's DiseaseBehcet DiseaseDrug: InfliximabJanssen Korea, Ltd., KoreaNULLCompleted19 Years75 YearsAll33Phase 3Korea, Republic of
30EUCTR2014-002108-25-DE
(EUCTR)
17/06/201525/11/2014Study 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.NULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
31EUCTR2014-002108-25-IT
(EUCTR)
24/02/201513/05/2015Study 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;France;Greece;Turkey;Israel;Germany;Japan;Italy;Korea, Republic of
32NCT02307513
(ClinicalTrials.gov)
December 30, 20142/12/2014A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's DiseaseA 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 DiseaseBehçet's SyndromeDrug: Apremilast;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll207Phase 3United States;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Lebanon;Turkey
33NCT02258867
(ClinicalTrials.gov)
November 20142/10/2014Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease UveitisA Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease UveitisBehcet's Disease UveitisDrug: Placebo;Drug: GevokizumabXOMA (US) LLCNULLTerminated18 YearsN/ABoth4Phase 3United States
34NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid 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 SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaCompleted18 YearsN/AAll81Phase 2France
35JPRN-UMIN000012469
2013/12/0202/12/2013Comparison of Adalimumab and Steroid in Intestinal Behcet's diseaseComparison of Adalimumab and Steroid in Intestinal Behcet's disease - Castle Study Intestinal Behcet's diseaseSubcutaneous 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 GroupNULLRecruiting15years-oldNot applicableMale and Female50Not selectedJapan
36EUCTR2012-001125-27-GB
(EUCTR)
15/01/201312/09/2012Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitisA 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 ServierNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Portugal;Hong Kong;Saudi Arabia;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of
37EUCTR2012-001125-27-PT
(EUCTR)
04/01/201313/09/2012Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitisA 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 ServierNULLNot RecruitingFemale: yes
Male: yes
44Phase 3Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of
38NCT02620618
(ClinicalTrials.gov)
January 201326/11/2015Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical StudyIntravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical StudyBehçet's Disease;UveitisDrug: Intravitreal InfliximabCairo UniversityNULLCompletedN/AN/ABoth20Phase 1/Phase 2NULL
39EUCTR2012-001125-27-IT
(EUCTR)
26/11/201221/09/2012Efficacy of gevokizumab in the treatment of patients with Behcet`s disease uveitisA 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 SERVIERNULLNot RecruitingFemale: yes
Male: yes
110Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;Brazil;Tunisia;Germany;China;Korea, Republic of
40NCT01965145
(ClinicalTrials.gov)
November 201217/9/2013Efficacy 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 UveitisBehcet's UveitisDrug: Gevokizumab;Drug: PlaceboInstitut de Recherches Internationales ServierNULLTerminated18 YearsN/AAll84Phase 3Korea, Republic of;United Kingdom
41EUCTR2012-001125-27-ES
(EUCTR)
17/10/201202/10/2012Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitisA 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.NULLNot RecruitingFemale: yes
Male: yes
110Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of
42EUCTR2012-001125-27-GR
(EUCTR)
03/10/201213/09/2012Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitisA 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 ServierNULLNot RecruitingFemale: yes
Male: yes
110Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;Italy;United Kingdom;India;France;Brazil;Tunisia;Germany;China;Korea, Republic of
43EUCTR2012-001125-27-DE
(EUCTR)
24/09/201212/09/2012Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitisA 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 ServierNULLNot RecruitingFemale: yes
Male: yes
44Portugal;Saudi Arabia;Hong Kong;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;India;France;Brazil;Germany;Tunisia;China;Korea, Republic of
44NCT01532570
(ClinicalTrials.gov)
January 20126/2/2012Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special LesionsTo Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Patients With Behcet's Disease ( BD ) With Special Lesions After the Administration of TA-650Behcet's Disease;Behcet Syndrome;Neuro-Behcet's DiseaseDrug: TA-650Mitsubishi Tanabe Pharma CorporationNULLCompleted16 Years75 YearsAll18Phase 3Japan
45NCT01720628
(ClinicalTrials.gov)
November 201123/10/2012The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's DiseaseBehçet's DiseaseOther: serum levels of angiogenin, bFGF, VEGFTurkish Ophthalmology SocietyNULLCompleted18 Years65 YearsBoth86N/ATurkey
46EUCTR2010-024152-29-DE
(EUCTR)
02/09/201121/06/2011An 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 TübingenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Germany
47NCT01441076
(ClinicalTrials.gov)
September 201124/9/2011Anakinra for Behcet s DiseaseA Pilot Study of Anakinra in Behcet's Disease (BD)Autoimmune Connective Tissue Disorder;Immune System DiseasesDrug: AnakinraNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years65 YearsAll6Phase 1/Phase 2United States
48NCT01243671
(ClinicalTrials.gov)
October 201017/11/2010A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's DiseaseA Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's DiseaseIntestinal Behçet's DiseaseBiological: AdalimumabAbbVie (prior sponsor, Abbott)Eisai Co., Ltd.Completed15 YearsN/AAll20Phase 3Japan
49NCT00931957
(ClinicalTrials.gov)
October 201030/6/2009Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's DiseaseEtanercept: Single Blind Control Study in Ocular Manifestations of Behcet's DiseaseBehcet Syndrome;Uveal DiseaseDrug: Etanercept, Methotrexate, PrednisoloneTehran University of Medical SciencesWyeth is now a wholly owned subsidiary of PfizerRecruiting16 Years60 YearsBoth80N/AIran, Islamic Republic of
50NCT01211977
(ClinicalTrials.gov)
August 27, 201029/9/2010A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and Behcet's DiseaseA 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 DiseaseDrug: XOMA 052National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLWithdrawn18 YearsN/AAll0Phase 1/Phase 2United States
51EUCTR2009-013901-33-DE
(EUCTR)
21/06/201003/03/2010A 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 StudyA 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 AGNULLNot RecruitingFemale: yes
Male: yes
112France;Greece;Spain;Austria;Germany
52EUCTR2009-013901-33-GR
(EUCTR)
15/06/201022/02/2011A 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 - C2303E1A 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 AGNULLNot RecruitingFemale: yes
Male: yes
102Germany;France;Spain;Greece;Austria
53NCT04328064
(ClinicalTrials.gov)
May 201029/8/2011The Role of Rosuvastatin on Vascular Involvement in Behçet's DiseaseBehcet's DiseaseDrug: Rosuvastatin calcium 40mg;Drug: Placebo oral tabletUniversity of AlexandriaNULLCompleted17 Years65 YearsAll56N/ANULL
54EUCTR2009-013901-33-FR
(EUCTR)
07/04/201016/02/2010A 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 therapyA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146France;Greece;Spain;Austria;Germany
55EUCTR2009-013901-33-ES
(EUCTR)
18/02/201018/01/2010Extensión 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 - C2303E1Extensión 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.NULLNot RecruitingFemale: yes
Male: yes
159Germany;France;Spain;Greece;Austria
56NCT01306955
(ClinicalTrials.gov)
February 20101/3/2011The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's DiseaseThe Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot StudyBehcet's DiseaseDrug: methylorednisolone;Other: dextrose water 5%Tehran University of Medical SciencesNULLRecruiting10 Years70 YearsBoth34Phase 4Iran, Islamic Republic of
57EUCTR2009-011237-27-DE
(EUCTR)
17/11/200906/08/2009A 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) - C2303A 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 diseaseProduct Name: AIN457
Product Code: AIN457
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
112Hungary;Germany;France;Spain;Italy;Greece;Austria
58EUCTR2009-013901-33-AT
(EUCTR)
12/11/200913/10/2009A 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 - C2303E1A 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 AGNULLNot RecruitingFemale: yes
Male: yes
112Germany;France;Spain;Greece;Austria
59EUCTR2009-011237-27-FR
(EUCTR)
23/10/200906/08/2009A 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 therapyA 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 AgNULLNot RecruitingFemale: yes
Male: yes
102France;Hungary;Greece;Spain;Austria;Germany;Italy
60EUCTR2009-011237-27-ES
(EUCTR)
20/10/200905/08/2009Estudio 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. - C2303Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Hungary;Greece;Spain;Austria;Germany;Italy
61EUCTR2009-011237-27-HU
(EUCTR)
15/10/200929/07/2009A 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 - C2303A 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 AgNULLNot RecruitingFemale: yes
Male: yes
112France;Hungary;Greece;Spain;Austria;Germany;Italy
62EUCTR2009-011237-27-AT
(EUCTR)
14/10/200918/09/2009A 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 - C2303A 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 diseaseProduct Name: AIN457
Product Code: AIN457
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
112Hungary;Germany;France;Spain;Italy;Greece;Austria
63NCT00995709
(ClinicalTrials.gov)
October 200913/10/2009Phase III Study in Refractory Behcet's DiseaseA 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 TherapyBehcet DiseaseDrug: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll118Phase 3United 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
64EUCTR2009-011237-27-GR
(EUCTR)
22/09/200907/10/2009A 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 - C2303A 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 diseaseProduct Name: AIN457
Product Code: AIN457
Novartis Pharma Services AgNULLNot RecruitingFemale: yes
Male: yes
112Hungary;Germany;France;Spain;Italy;Greece;Austria
65NCT00866359
(ClinicalTrials.gov)
August 1, 200918/3/2009A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet DiseaseA 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 DiseaseBehcet SyndromeDrug: Apremilast (CC-10004);Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll111Phase 2United States;Turkey
66NCT00720928
(ClinicalTrials.gov)
July 200818/7/2008Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's DiseaseA 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 DiseaseOcular Behcet's Disease,;Non-Infectious Uveitis;Refractory UveitisDrug: flucinolone acetonideAsan Medical CenterSamsung Medical Center;Seoul National University Hospital;Kyunghee University Medical CenterRecruiting18 YearsN/ABoth15Phase 4Korea, Republic of
67NCT00550498
(ClinicalTrials.gov)
December 200727/10/2007Stem Cell Transplantation in Ocular Lesions of Behcet's DiseasePhase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's DiseaseRetinitis;Behcet's SyndromeBiological: Autologous Stem Cell TransplantationTehran University of Medical SciencesNULLTerminated16 YearsN/ABoth5Phase 1Iran, Islamic Republic of
68NCT00483184
(ClinicalTrials.gov)
April 20065/6/2007Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's DiseasePhase II Study, Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçet's DiseaseBehcet Syndrome;Behcet Disease;Mucocutaneous UlcerationBiological: Veldona,Nobel PharmaceuticalsAmarillo Biosciences, Inc.Completed18 Years75 YearsAll84Phase 2Turkey
69NCT00664599
(ClinicalTrials.gov)
April 200620/4/2008Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's DiseaseEffect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)Behcet's SyndromeDrug: Rituximab;Drug: Cytotoxic CombinationTehran University of Medical SciencesHoffmann-La RocheCompleted16 YearsN/ABoth20Phase 2Iran, Islamic Republic of
70NCT00167583
(ClinicalTrials.gov)
November 20049/9/2005Interferon-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 VasculitisDrug: Cyclosporin A;Drug: Interferon-alpha2aUniversity Hospital TuebingenNULLCompleted18 Years75 YearsAll37Phase 3Germany
71NCT00278512
(ClinicalTrials.gov)
August 200315/1/2006Hematopoietic Stem Cell Support in VasculitisHigh Dose Immune Suppression With Hematopoietic Stem Cell Support in Refractory Vasculitis, Necrotizing Vasculitis, Neurovascular Behcet's Disease, and Sjogren's SyndromeVasculitisBiological: Autologous Stem Cell Transplant;Biological: Allogeneic Stem Cell TransplantNorthwestern UniversityNULLTerminated16 Years60 YearsBoth7Phase 1United States
72NCT00700297
(ClinicalTrials.gov)
August 200217/6/2008Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's DiseaseA Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s DiseaseBehcet's SyndromeDrug: Colchicine;Drug: PlaceboTehran University of Medical SciencesNULLCompleted14 Years60 YearsBoth169Phase 2Iran, Islamic Republic of
73NCT00001865
(ClinicalTrials.gov)
July 19993/11/1999HAT in Eye Complications of Behcet's DiseaseA Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcet's DiseaseBehcet's Syndrome;Retinal Disease;UveitisDrug: DaclizumabNational Eye Institute (NEI)NULLCompletedN/AN/ABoth26Phase 2United States
74EUCTR2019-002787-27-FR
(EUCTR)
18/12/2020Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA 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.NULLNAFemale: yes
Male: yes
60Phase 3France;Israel;Netherlands;Switzerland
75EUCTR2019-002787-27-NL
(EUCTR)
11/02/2021Apremilast study in children with active oral ulcers associated with Behçet’s DiseaseA 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.NULLNAFemale: yes
Male: yes
60Phase 3France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy
76EUCTR2017-002264-41-FR
(EUCTR)
19/07/2017NA 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)NULLNA Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance