IMUREL ( DrugBank: - )


4 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
46悪性関節リウマチ1
96クローン病10
97潰瘍性大腸炎3

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
1EUCTR2018-001292-21-FR
(EUCTR)
27/07/201805/06/2018Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 yearsDisease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years Secondary Progressive Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AVONEX
Product Name: BETAFERON
Product Code: L03 AB 08
Product Name: EXTAVIA
Product Name: REBIF
Product Name: PLEDIGRY
Product Name: COPAXONE
Product Name: AUBAGIO
Product Name: TECFIDERA
Product Name: GILENYA
Product Name: TYSABRI
Product Name: IMUREL
Product Name: NOVATREX
Product Name: CELLCEPT
Product Name: ENDOXAN
CHU de RennesNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004720-35-NO
(EUCTR)
04/05/201526/01/2015A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR Rheumatoid arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Metex
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Imurel
INN or Proposed INN: IMUREL
Other descriptive name: AZATHIOPRINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
INN or Proposed INN: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Plaquenil
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Sweden

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
1EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
2EUCTR2014-002311-41-NL
(EUCTR)
25/05/201818/12/2017A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPAREA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4France;Belgium;Germany;Netherlands;United Kingdom;Sweden
3EUCTR2016-000522-18-BE
(EUCTR)
02/05/201808/01/2018Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate
PIBDNetNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
4EUCTR2016-004112-35-SE
(EUCTR)
04/04/201821/06/2017A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel diseaseLow-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Sweden
5EUCTR2014-002311-41-DE
(EUCTR)
25/11/201521/08/2015A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy - SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4France;Australia;Netherlands;Germany;United Kingdom;Sweden
6EUCTR2014-002311-41-SE
(EUCTR)
21/08/201501/07/2015A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapyA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Imurel 25 mg
Product Name: Imurel
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Trade Name: Puri-Nethol 50 mg
Product Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Metoject
Product Name: Metotrexat
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 4France;Netherlands;Germany;United Kingdom;Sweden
7EUCTR2014-002311-41-FR
(EUCTR)
12/08/201422/06/2015A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPAREA proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France;United Kingdom;Sweden
8EUCTR2013-001503-37-DK
(EUCTR)
31/05/201306/05/2013Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel DiseaseEffect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease Inflammatory Bowel Disease, (Ulcerativ colitis, Crohns disease)
MedDRA version: 14.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: allopurinol
Other descriptive name: ALLOPURINOL SODIUM
Marianne Kiszka-KanowitzNULLNot RecruitingFemale: yes
Male: yes
46Phase 3Denmark
9EUCTR2011-000885-36-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
10EUCTR2016-000522-18-FR
(EUCTR)
21/06/2016Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate
PIBDNetNULLNAFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom

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
1EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
2EUCTR2016-004112-35-SE
(EUCTR)
04/04/201821/06/2017A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel diseaseLow-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Sweden
3EUCTR2016-002433-30-DK
(EUCTR)
25/08/201621/06/2016Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitisLow-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Allopurinol
INN or Proposed INN: ALLOPURINOL
Hvidovre HospitalNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Denmark