AZATIOPRINA ( DrugBank: Azatioprina )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
96クローン病2
97潰瘍性大腸炎4

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-004937-13-IT
(EUCTR)
17/08/200604/07/2007multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trialmulticentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial patients with relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL
INN or Proposed INN: Azathioprine
Trade Name: REBIF SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
Trade Name: BETAFERON SC 15F 0,25MG 15SIR
INN or Proposed INN: Interferon beta-1b
Trade Name: REBIF SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a
Trade Name: AVONEX IM 4SIR 30MCG/0,5ML 4AG
INN or Proposed INN: Interferon beta-1a
Universita di FirenzeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000522-18-IT
(EUCTR)
24/02/201708/06/2021Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease.Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL Crohn Disease
MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML
Product Name: Methotrexate
Product Code: N.A
Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL
Product Name: Humira
Product Code: N.A
Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE
Product Name: Azatioprina
Product Code: N.A
Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE
Product Name: Purinethol
UMBERTO I - POLICLINICO DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy
2EUCTR2011-000885-36-ES
(EUCTR)
26/12/201129/11/2011Adalimub treatment to prevent recurrency post-surgery in Crohn disease.Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment - APPRECIA Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Other descriptive name: Adalimumab
Trade Name: Imurel
Product Name: Imurel
INN or Proposed INN: Azatioprina
Other descriptive name: Imurel
Trade Name: Flagyl
Product Name: Flagyl
INN or Proposed INN: Metronidazol
Other descriptive name: Flagyl
GETECCUNULLNot RecruitingFemale: yes
Male: yes
Spain

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003420-16-IT
(EUCTR)
29/01/202102/08/2021A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT Moderate to severe ulcerative colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amgevita
Product Name: Adalimumab
Product Code: [n.d.]
INN or Proposed INN: ADALIMUMAB
Product Name: Azatioprina
Product Code: [n.d.]
INN or Proposed INN: AZATIOPRINA
Product Name: Prednisone
Product Code: [n.d.]
INN or Proposed INN: PREDNISONE
INN or Proposed INN: PREDNISONE
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 4Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
2EUCTR2016-002707-25-IT
(EUCTR)
31/03/201713/01/2021n.a.Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a. patients with ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
INN or Proposed INN: INFLIXIMAB
Trade Name: AZAFOR - 50 MG COMPRESSE RIVESTITE CON FILM 50 COMPRESSE IN BLISTER PVC/PVDC/AL
INN or Proposed INN: AZATIOPRINA
IRCCS ISTITUTO CLINICO HUMANITASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Italy
3EUCTR2012-001653-13-IT
(EUCTR)
10/07/201327/03/2013New Therapeutic Strategy in Ulcerative ColitisNew Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in PediatricPatients Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: AZAFOR 50mg
Product Name: AZATIOPRINA
Product Code: AZA
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Dipartimento di Pediatria Università Federico II di NapoliNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Italy
4EUCTR2006-002670-22-ES
(EUCTR)
20/09/200726/07/2007 Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte). Colitis Ulcerosa
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom