AZA ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症6
40高安動脈炎1
96クローン病79
97潰瘍性大腸炎44

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001229-26-ES
(EUCTR)
21/01/202214/12/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy
2NCT03490539
(ClinicalTrials.gov)
May 7, 201821/3/2018Disease-Modifying Treatments for Myasthenia GravisProspective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-modifying Treatments for Myasthenia GravisNeurological Disorder;Autoimmune DiseasesDrug: Mycophenolate Mofetil;Drug: AzathioprineDuke UniversityBeth Israel Deaconess Medical Center;Patient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll167United States;Canada
3ChiCTR1900024692
2018-01-012019-07-22Comparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modificationComparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modification Myasthenia Graviseye muscles type:bromopyramine + hormone;eye muscles type:bromopyramine + hormone + azathioprine;eye muscles type:bromopyramine + hormone + cyclosporine;non-eye muscle type:bromopyramine + hormone + azathioprine;non-eye muscle type :bromopyramine + hormone + cyclosporine;Neurology Department of the 940th Hospital of Joint Logistics Support force of Chinese People's Liberation ArmyNULLRecruiting380Botheye muscles type:20;eye muscles type:20;eye muscles type:20;non-eye muscle type:20;non-eye muscle type :20;N/AChina
4NCT01727193
(ClinicalTrials.gov)
September 20128/11/2012The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand ThymectomyThe Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand ThymectomyMyasthenia GravisDrug: Azathioprine;Drug: LeflunomideFirst Affiliated Hospital, Sun Yat-Sen UniversityNULLCompleted12 Years65 YearsAll290Phase 3China
5NCT00987116
(ClinicalTrials.gov)
June 200929/9/2009Study Comparing Two Tapering Strategies of Prednisone in Myasthenia GravisComparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter StudyMyasthenia GravisDrug: Prednisone - AzathioprineAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll118Phase 4France
6NCT00997412
(ClinicalTrials.gov)
May 200916/10/2009Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisRandomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisMyasthenia GravisDrug: Mycophenolic acid;Drug: AZAQualitix Clinical Research Co., Ltd.NULLActive, not recruiting20 Years70 YearsBoth40N/ANULL

40. 高安動脈炎


臨床試験数 : 24 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03096275
(ClinicalTrials.gov)
March 16, 201713/3/2017Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's ArteritisComparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's ArteritisTakayasu ArteritisDrug: MMF;Drug: CYC;Drug: Glucocorticoids;Drug: MTX;Drug: AZAChinese SLE Treatment And Research GroupPeking Union Medical College HospitalActive, not recruiting18 YearsN/AAll138Phase 3China

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05584228
(ClinicalTrials.gov)
April 1, 202326/9/2022Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's DiseaseSyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority TrialCrohn DiseaseDrug: Azathioprine + infliximab;Procedure: Intestinal resectionNantes University HospitalGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNot yet recruiting18 Years70 YearsAll150N/ANULL
2NCT05040464
(ClinicalTrials.gov)
August 26, 202126/8/2021Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialComparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialCrohn Disease;Azathioprine;MethotrexateDrug: AZA capsules;Drug: MTX;Biological: blood sampleCentre Hospitalier Universitaire, AmiensNULLRecruiting18 YearsN/AAll166Phase 3France
3ChiCTR2100049326
2021-08-012021-07-30A Prospective, Single-arm Clinical Study of the Efficacy and Safety of Adalimumab Incremental Therapy in Patients With Fistulizing Crohn's DiseaseA Prospective, Single-arm Clinical Study of the Efficacy and Safety of Adalimumab Incremental Therapy in Patients With Fistulizing Crohn's Disease fistulizing Crohn's diseaseConventional treatment group:Adalimumab, every 2 weeks, 40mg each time, 12 weeks of treatment;Incremental treatment group:Adalimumab, once every 2 weeks, each time 80mg, 12 weeks of treatment;Conventional treatment combination group:Adalimumab, every 2 weeks, 40mg each time, 12 weeks of treatment. Azathioprine, 1.5-4mg/kg/day, course of treatment for 12 weeks;Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting16BothConventional treatment group:20;Incremental treatment group:20;Conventional treatment combination group:20;Phase 4China
4EUCTR2019-002942-19-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
5NCT04761952
(ClinicalTrials.gov)
February 13, 202114/2/2021N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's DiseaseN-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease:a Prospective Randomized Controlled TrialInflammatory Bowel Diseases;Crohn Disease;Polyunsaturated Acid LipidosisDrug: azathioprine;Drug: infliximab;Drug: N-3 Polyunsaturated Fatty AcidsSixth Affiliated Hospital, Sun Yat-sen UniversityNULLNot yet recruiting18 Years80 YearsAll236N/ANULL
6NCT04713631
(ClinicalTrials.gov)
January 21, 20213/12/2020Safety and Efficacy of Artesunate & Curcumin in Crohn's DiseasePhase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety, Efficacy of Artesunate & Curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of AzathioprineCrohn's DiseaseDrug: Artesunate;Drug: Curcumin;Drug: Placebo A;Drug: Placebo CSanjay Gandhi Postgraduate Institute of Medical SciencesSt George's University of London, London, UKRecruiting18 Years65 YearsAll40Phase 2India
7NCT03681652
(ClinicalTrials.gov)
February 11, 201920/9/2018Post-Operative Crohn's Disease Outcome in ChildrenPost-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open StudyCrohn DiseaseDrug: Azathioprine;Drug: Anti-TNF DrugSchneider Children's Medical Center, IsraelNULLRecruiting6 Years18 YearsAll100Israel
8EUCTR2014-002311-41-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
9NCT04160325
(ClinicalTrials.gov)
May 14, 20183/11/2019Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After SurgeryThe Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After SurgeryCrohn DiseaseDietary Supplement: postoperative 3-month exclusive enteral nutrition;Drug: azathioprine;Other: normal dietZhu WeimingSixth Affiliated Hospital, Sun Yat-sen University;Sir Run Run Shaw Hospital;The First Affiliated Hospital of Anhui Medical University;Beijing Tsinghua Changgung HospitalRecruiting18 Years65 YearsAll198N/AChina
10EUCTR2016-000522-18-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
11EUCTR2016-000522-18-CZ
(EUCTR)
24/04/201825/04/2018Risk 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-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Azathioprin
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
12EUCTR2016-004112-35-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
13EUCTR2016-000522-18-GB
(EUCTR)
28/03/201805/12/2017Risk-stratified randomised 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.Risk Stratified randomised 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 Paediatric Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40mg/0.4ml pre-filled syringe
Product Name: Humira 40mg/0.4ml pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SUB20016
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Mercaptopurine
INN or Proposed INN: Mercaptopurine
Other descriptive name: 6-Mercaptopurine
PIBD netNULLAuthorised-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;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom
14EUCTR2016-000522-18-NL
(EUCTR)
28/12/201703/07/2017Risk 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.Risk 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]Trade Name: Humira
Product Name: humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprine
Product Name: imuran
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: methotrexate
Product Name: methotrexate
Product Code: L01BA
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLNot RecruitingFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
15NCT03393247
(ClinicalTrials.gov)
June 1, 20178/7/2017The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CDThe Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort StudyCrohn DiseaseDrug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14Sixth Affiliated Hospital, Sun Yat-sen UniversityNULLUnknown status14 Years60 YearsAll160N/AChina
16NCT03185611
(ClinicalTrials.gov)
May 18, 201711/6/2017Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's DiseaseEffectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled TrialCrohn DiseaseDrug: Rifaximin;Drug: AzathioprineSixth Affiliated Hospital, Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw HospitalRecruiting18 Years65 YearsAll120Phase 3China
17NCT02852694
(ClinicalTrials.gov)
February 28, 20179/6/2016Reduce Risk for Crohn's Disease PatientsRisk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment StrategyCrohn's DiseaseDrug: Methotrexate;Drug: Adalimumab;Drug: Azathioprine / 6 MercaptopurinePIBD-NetEuropean CommissionRecruiting6 Years17 YearsAll312Phase 4France
18EUCTR2016-000522-18-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
19EUCTR2016-000522-18-DE
(EUCTR)
05/01/201701/08/2016Risk 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-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Product Name: Methotrexat
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBD-NetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 3France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
20NCT02998827
(ClinicalTrials.gov)
November 201624/11/2016Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD PatientsCrohn DiseaseDrug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutritionSixth Affiliated Hospital, Sun Yat-sen UniversityNULLEnrolling by invitationN/AN/AFemale90N/ANULL
21ChiCTR1800020305
2016-01-012018-12-23A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's diseaseInfliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI crohn's disease;K50.900Group 2:infliximab + azathioprine;Group 1:infliximab alone;Department of Gastroenterology, Nanfang Hospital, Southern Medical UniversityNULLRecruiting1280BothGroup 2:41;Group 1:45;China
22ChiCTR-IIR-16007751
2016-01-012016-01-13Clinical study of acupuncture and moxibustion treatment for Cohn's diseaseMolecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease Crohn's diseaseAcupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine;Shanghai Research Institute of Acupuncture and MeridianNULLRecruiting1670BothAcupuncture Group:40;Placebo acupuncture group:40;Drug Group:40;I (Phase 1 study)China
23EUCTR2014-002311-41-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
24EUCTR2014-002311-41-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
25EUCTR2014-002311-41-GB
(EUCTR)
14/07/201530/06/2015A 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 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) - SPARE Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Remicade
Product Name: INFLIXIMAB
Trade Name: Imuran
Product Name: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Mercaptopurine
Product Name: Mercaptopurine
University of EdinburghNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France;Belgium;Germany;United Kingdom;Sweden
26EUCTR2010-020137-10-LT
(EUCTR)
13/05/201512/03/2015Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
27NCT02413047
(ClinicalTrials.gov)
May 20156/3/2015Evaluate if Response to Infliximab or Adalimumab May be Regained With an ImmunomodulatorA Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an ImmunomodulatorInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: Azathioprine;Drug: 6 mercaptopurine;Drug: MethotrexateIndiana UniversityNULLTerminated18 Years80 YearsAll3N/AUnited States
28NCT02517684
(ClinicalTrials.gov)
April 20151/7/2015Top-down Infliximab Study in Kids With Crohn's DiseaseTop-down Infliximab Study in Kids With Crohn's DiseaseCrohn's DiseaseDrug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: AzathioprineErasmus Medical CenterZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of PfizerActive, not recruiting3 Years17 YearsAll100Phase 4Belgium;Finland;Netherlands;Denmark;Italy;Poland
29JPRN-UMIN000032485
2015/01/0108/05/2018efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's diseaseefficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study Cron's diseaseadalimumab
azathiopurine
Sakura medical center, Toho universityNULLComplete: follow-up complete20years-old70years-oldMale and Female20Not selectedJapan
30NCT02332356
(ClinicalTrials.gov)
September 20144/1/2015Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseTherapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseCrohn DiseaseDrug: azathioprine or adalimumab and infliximabTokyo Medical and Dental UniversityNULLRecruiting16 Years65 YearsAll100Phase 3Japan
31EUCTR2014-002311-41-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
32EUCTR2013-001503-37-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
33JPRN-UMIN000010524
2013/03/2917/04/2013Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudyOptimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy - Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy Crohn's diseaseAdalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.
Tokyo Medical & Dental University GastroenterologyNULLComplete: follow-up complete15years-oldNot applicableMale and Female20Not selectedJapan
34NCT01817972
(ClinicalTrials.gov)
March 201319/3/2013Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's DiseaseA Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Certolizumab pegol;Drug: AzathioprineGastroenterology Research of AmericaUCB PharmaNot yet recruiting18 Years70 YearsBoth65Phase 3United States
35NCT01802593
(ClinicalTrials.gov)
February 201324/12/2012Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine FailurePhase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator FailureCrohn's DiseaseDrug: AZATHIOPRINE or METHOTREXATEProf. Arie LevineNULLTerminated6 Years18 YearsBoth20Phase 4Israel
36JPRN-UMIN000009596
2013/01/0121/12/2012Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). - Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial. Crohn`s diseaseWithdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Not selectedJapan
37NCT01880307
(ClinicalTrials.gov)
January 20137/6/2013Infliximab Top-down in Pediatric CrohnInfliximab Top-down Study in Kids With Crohn's DiseaseCrohn's DiseaseDrug: Azathioprine;Drug: Infliximab;Drug: PrednisolonErasmus Medical CenterUniversity of Roma La Sapienza;University Hospital, BrusselsTerminated3 Years17 YearsBoth13Phase 4Italy;Netherlands
38NCT01823042
(ClinicalTrials.gov)
October 201225/3/2013The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).Crohn's DiseaseDrug: azathioprine+enteral nutrition;Drug: AzathioprineJinling Hospital, ChinaNULLRecruiting18 Years75 YearsBoth100N/AChina
39NCT01564823
(ClinicalTrials.gov)
June 201231/1/2012Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s DiseaseAdalimumab on Preventing Postoperative Recurrence of Crohn's DiseaseCrohn´s DiseaseDrug: Metronidazole;Drug: Azathioprine;Drug: AdalimumabGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaEffice Servicios Para la Investigacion S.L.Completed18 YearsN/ABoth86Phase 3Spain
40NCT01957423
(ClinicalTrials.gov)
March 201224/9/2013Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients.Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.Crohn's DiseaseDietary Supplement: Whey protein;Dietary Supplement: Soy proteinUniversity of Campinas, BrazilFundação de Amparo à Pesquisa do Estado de São PauloCompletedN/AN/ABoth41N/ABrazil
41EUCTR2010-020137-10-HU
(EUCTR)
12/01/201222/11/2011Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden
42EUCTR2011-000885-36-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
43JPRN-UMIN000006232
2011/10/0101/09/2011Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximabEvaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab - High dose infliximab with azathiopurine add-on therapy Crohn's diseasetreatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
treatment with only high dose infliximab
Saitama Medical UniversityNULLComplete: follow-up complete15years-old70years-oldMale and Female40Not selectedJapan
44JPRN-UMIN000005689
2011/09/0131/05/2011GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trialGMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial - Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease Crohn's diseasePatients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete12years-old75years-oldMale and Female60Not applicableJapan
45EUCTR2010-020137-10-BE
(EUCTR)
23/03/201104/10/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
46JPRN-UMIN000005146
2011/03/0125/02/2011Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) - Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) Crohn's diseaseAdministration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Phase 4Japan
47NCT01235689
(ClinicalTrials.gov)
February 11, 20114/11/2010Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's DiseaseAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Adalimumab;Drug: Prednisone;Drug: AzathioprineAbbVie (prior sponsor, Abbott)NULLCompleted18 Years75 YearsAll252Phase 3Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
48EUCTR2010-020137-10-NL
(EUCTR)
17/12/201023/12/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden
49EUCTR2010-020137-10-CZ
(EUCTR)
08/11/201004/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
50EUCTR2010-020137-10-IT
(EUCTR)
07/11/201008/11/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM Crohn`s disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: Azathioprin-ratiopharm 25 mg
INN or Proposed INN: Azathioprine
Trade Name: Azathioprine - ratiopharm 50 mg
INN or Proposed INN: Azathioprine
Trade Name: Decortin 5 mg
INN or Proposed INN: Prednisone
Trade Name: Decortin 20 mg
INN or Proposed INN: Prednisone
Abbott GmBH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
51EUCTR2010-020137-10-ES
(EUCTR)
20/10/201020/08/2010Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMEstudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Enfermedad de Crohn.Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
52EUCTR2010-020137-10-FR
(EUCTR)
14/10/201023/08/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
Abbott GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
53EUCTR2010-020137-10-DE
(EUCTR)
05/10/201020/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
54EUCTR2010-020137-10-GB
(EUCTR)
20/09/201019/07/2010 Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
55EUCTR2010-020137-10-AT
(EUCTR)
16/09/201011/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
56EUCTR2010-020137-10-SE
(EUCTR)
15/09/201027/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
57NCT01015391
(ClinicalTrials.gov)
November 200917/11/2009Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's DiseaseA Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical ResectionCrohn's DiseaseDrug: T2;Drug: AzathioprineJinling Hospital, ChinaNULLRecruiting18 YearsN/ABoth100N/AChina
58NCT01559142
(ClinicalTrials.gov)
November 200819/3/2012Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn DiseaseEfficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized StudyCrohn DiseaseDrug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone)Children's Memorial Health Institute, PolandNULLActive, not recruiting7 Years17 YearsBoth100Phase 3Poland
59EUCTR2008-001131-35-NL
(EUCTR)
14/05/200829/05/2008Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trialAzathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 monthsTrade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565
Academic Medical Center, department of Gastroenterology and hepatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
60NCT00521950
(ClinicalTrials.gov)
September 200727/8/2007Cost-effectiveness of TPMT PharmacogeneticsPharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System.Inflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisGenetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRadboud UniversityCompleted18 YearsN/ABoth853N/ANetherlands
61JPRN-UMIN000004427
2007/06/0101/11/2010A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal ResectionA Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection - Infliximab for Crohn's Disease Patients after Intestinal Resection Crohn's diseaseNon-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).

Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.
Lower GI disease, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female30Phase 2,3Japan
62EUCTR2004-002815-10-DE
(EUCTR)
12/12/200525/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
63NCT02247258
(ClinicalTrials.gov)
October 200519/9/2014Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study.Crohn Disease;Recurrence;Azathioprine;PreventionDrug: Azathioprine;Drug: Azathioprine in case of endoscopic recurrence;Procedure: Ileocolonoscopy;Procedure: Small bowel follow troughUniversitaire Ziekenhuizen LeuvenInternational organization for the study of inflammatory bowel disease (IOIBD)Terminated16 Years75 YearsBoth63Phase 2Belgium;Czech Republic;Greece
64EUCTR2004-002815-10-GB
(EUCTR)
25/07/200526/05/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Spain;Denmark;Austria;Germany;United Kingdom;Sweden
65EUCTR2004-002815-10-ES
(EUCTR)
18/07/200516/05/2006Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Spain;Denmark;Austria;Germany;United Kingdom;Sweden
66EUCTR2004-002815-10-DK
(EUCTR)
07/07/200510/07/2008Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
67NCT00546546
(ClinicalTrials.gov)
July 200518/10/2007Early Immunosuppressants in Crohn's DiseaseEffect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's DiseaseCrohn's DiseaseDrug: early immunosuppressants (azathioprine, methotrexate)Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesSociété Nationale Française de Gastroentérologie;Société Nationale Française de GastroentérologieCompleted18 YearsN/ABoth120Phase 4France
68NCT00113503
(ClinicalTrials.gov)
July 20058/6/2005Imuran Dosing in Crohn's Disease StudyA Multi-site Trial of Azathioprine Dosing in Crohn's DiseaseCrohn's DiseaseDrug: Azathioprine weight-based dose;Drug: Azathioprine individualised doseNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Prometheus LaboratoriesTerminated10 Years70 YearsAll50Phase 2United States;Canada
69EUCTR2005-001148-22-SK
(EUCTR)
27/06/200512/05/2005A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicableA 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable Crohn's disease
MedDRA version: 7.1;Level: Low;Classification code 10011401
Trade Name: Certican
Product Name: Certican
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: Azathioprine
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Slovakia
70EUCTR2004-002815-10-SE
(EUCTR)
24/05/200511/04/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500United Kingdom;Germany;Denmark;Spain;Sweden
71EUCTR2004-002815-10-AT
(EUCTR)
04/05/200530/03/2005Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONICMulticenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
500Spain;Denmark;Austria;Germany;United Kingdom;Sweden
72NCT00098111
(ClinicalTrials.gov)
April 20053/12/2004Imuran (Azathioprine) Dose-Ranging Study in Crohn's DiseaseA Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS)Crohn's DiseaseDrug: azathioprineMassachusetts General HospitalNULLTerminated14 YearsN/ABoth31Phase 3United States
73NCT00094458
(ClinicalTrials.gov)
March 200519/10/2004Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONICMulticenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic TherapyCrohn DiseaseBiological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusionCentocor Ortho Biotech Services, L.L.C.Schering-PloughCompleted21 Years99 YearsAll508Phase 3United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
74NCT00796250
(ClinicalTrials.gov)
November 1, 200321/11/2008Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With AzathioprineCrohn's DiseaseBiological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo InfliximabMerck Sharp & Dohme Corp.NULLTerminated18 Years65 YearsAll9Phase 3NULL
75NCT00976690
(ClinicalTrials.gov)
October 200211/9/2009Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseA Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn DiseaseCrohn DiseaseDrug: Azathioprine OR MesalazineGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLCompleted18 YearsN/ABoth83Phase 3France
76NCT00946946
(ClinicalTrials.gov)
February 200224/7/2009Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus MesalazineDouble-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic RecurrenceCrohn's DiseaseDrug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placeboDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth78Phase 3Austria;Germany
77NCT00554710
(ClinicalTrials.gov)
May 20016/11/2007Top Down Versus Step Up Strategies in Crohn's DiseaseThe Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the BeneluxCrohn's DiseaseDrug: infliximab+azathioprine;Drug: methylprednisolone or budesonideBelgian IBD Research GroupCentocor BV;Schering-PloughCompleted16 Years75 YearsBoth129Phase 4Belgium
78EUCTR2016-000522-18-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
79EUCTR2016-000522-18-PL
(EUCTR)
04/04/2018Risk-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 Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: HUMIRA
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
PIBDnet (Pediatric Inflammatory Bowel Disease Network)NULLNA Female: no
Male: no
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;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 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-BE
(EUCTR)
16/07/202130/06/2021A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitisSPRINT: 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;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amgevita
INN or Proposed INN: Adalimumab 40mg
Trade Name: Azathioprine
Other descriptive name: AZATHIOPRINE BP
Instituto Clinico HumanitasNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 4Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden
2NCT04882683
(ClinicalTrials.gov)
June 1, 20216/5/2021Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative ColitisClinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative ColitisUlcerative ColitisDrug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cellsShandong Qilu Stem Cells Engineering Co., Ltd.NULLRecruiting18 Years65 YearsAll50N/AChina
3ChiCTR2100046284
2021-05-062021-05-12Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis ulcerative colitisControl group:Prednisone+Azathioprine/Adalimumab;Test group:Prednisone+Azathioprine/Adalimumab+umbilical cord blood mononuclear cells;The Second Affiliated Hospital of Shandong University of Traditional Chinese MedicineNULLRecruiting1865BothControl group:25;Test group:25;China
4EUCTR2019-002942-19-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
5EUCTR2020-003420-16-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
6EUCTR2018-003558-26-GB
(EUCTR)
11/02/202005/11/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
7EUCTR2018-003558-26-FR
(EUCTR)
10/12/201908/02/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands
8EUCTR2018-003558-26-DE
(EUCTR)
30/10/201915/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
9NCT03760003
(ClinicalTrials.gov)
September 23, 201929/11/2018Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative ColitisA Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid TreatmentUlcerative ColitisDrug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: PlaceboAbivax S.A.NULLCompleted18 Years75 YearsAll254Phase 2United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
10EUCTR2018-003558-26-BE
(EUCTR)
29/08/201927/05/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
11EUCTR2018-003558-26-SI
(EUCTR)
12/06/201907/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
244Phase 2United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
12EUCTR2018-003558-26-IT
(EUCTR)
11/06/201922/01/2021Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - ABX464-103 Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABX464
Product Code: [ABX464]
Product Name: ABX464
Product Code: [ABX464]
AbivaxNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands
13EUCTR2018-003558-26-SK
(EUCTR)
23/05/201920/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
244Phase 2Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
14EUCTR2018-003558-26-CZ
(EUCTR)
22/05/201914/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;France;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy
15EUCTR2018-003558-26-HU
(EUCTR)
21/05/201925/03/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
232Phase 2United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
16EUCTR2018-003558-26-PL
(EUCTR)
20/05/201912/04/2019Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
244Phase 2Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany
17EUCTR2016-004112-35-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
18JPRN-UMIN000030988
2018/02/0101/02/2018Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapyOpen-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study) Ulcerative ColitisInduce azathioprine and continue maintenance therapy by azathioprine
Induce adalimumab and continue maintenance therapy by adalimumab
Sakura Medical Center, Toho universityNULLPending15years-oldNot applicableMale and Female53Not applicableJapan
19NCT03151525
(ClinicalTrials.gov)
May 8, 20178/5/2017Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative ColitisComparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by InfliximabColitis, UlcerativeDrug: Azathioprine;Drug: InfliximabIstituto Clinico HumanitasAgenzia Italiana del FarmacoRecruiting18 Years65 YearsAll100Phase 4Italy
20EUCTR2016-002707-25-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
21NCT03101800
(ClinicalTrials.gov)
December 14, 201627/1/2017Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative ColitisLow-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled TrialColitis, Ulcerative;Colitis Ulcerative ExacerbationDrug: Azathioprine and Allopurinol;Drug: AzathioprineHvidovre University HospitalAalborg University Hospital;Zealand University Hospital;University of Copenhagen;Odense University Hospital;Aarhus University Hospital;Regional Hospital Viborg;Vejle Hospital;Sydvestjysk Hospital EsbjergUnknown status18 Years80 YearsAll84Phase 3Denmark
22NCT02425852
(ClinicalTrials.gov)
December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
23EUCTR2016-002433-30-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
24NCT02579733
(ClinicalTrials.gov)
February 1, 201616/10/2015Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: Azathioprine;Drug: PlaceboKyungpook National University HospitalCelltrionTerminated18 Years80 YearsAll16Phase 4Korea, Republic of
25NCT02413047
(ClinicalTrials.gov)
May 20156/3/2015Evaluate if Response to Infliximab or Adalimumab May be Regained With an ImmunomodulatorA Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an ImmunomodulatorInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: Azathioprine;Drug: 6 mercaptopurine;Drug: MethotrexateIndiana UniversityNULLTerminated18 Years80 YearsAll3N/AUnited States
26ChiCTR-IPR-15005760
2015-01-122015-01-02Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical studySteroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study ulcerative colitisTCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule;Control:Azathioprine;Affiliated Hospital of Nanjing University of Chinese MedicineNULLPending1865BothTCM Group:60;Control:60;I (Phase 1 study)China
27EUCTR2012-001653-13-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
28JPRN-UMIN000006141
2011/10/0112/08/2011Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitisComparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis - Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis ulcerative colitisPatients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).
Department of Gastroenterology and Hepatology, Kyoto University HospitalNULLComplete: follow-up complete16years-old75years-oldMale and Female50Not applicableJapan
29JPRN-UMIN000003785
2010/07/0101/07/2010Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. - A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis. Ulcerative colitis5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).

5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of MedicineNULLComplete: follow-up complete16years-old65years-oldMale and Female80Phase 3Japan
30NCT00984568
(ClinicalTrials.gov)
November 200924/9/2009Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter StudyColitis, UlcerativeBiological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: AzathioprineMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/AAll28Phase 3Germany
31EUCTR2009-010065-23-DE
(EUCTR)
17/08/200914/04/2009Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone
Essex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
32EUCTR2006-002670-22-GB
(EUCTR)
11/06/200801/08/2007 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
33EUCTR2006-002670-22-SK
(EUCTR)
08/02/200815/04/2008 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
34EUCTR2006-002670-22-IT
(EUCTR)
27/11/200704/10/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: imuran
INN or Proposed INN: azathioprine
SCHERING-PLOUGHNULLNot RecruitingFemale: yes
Male: yes
600Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
35EUCTR2006-002670-22-DE
(EUCTR)
31/10/200712/06/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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 RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
36EUCTR2006-002670-22-PT
(EUCTR)
12/10/200720/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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 RecruitingFemale: yes
Male: yes
600Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
37EUCTR2006-002670-22-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
38EUCTR2006-002670-22-FR
(EUCTR)
07/09/200714/06/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) Ulcerative Colitis
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: Azathioprine (Imuran) 50 mg Overencapsulated Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
39NCT00521950
(ClinicalTrials.gov)
September 200727/8/2007Cost-effectiveness of TPMT PharmacogeneticsPharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System.Inflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisGenetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRadboud UniversityCompleted18 YearsN/ABoth853N/ANetherlands
40EUCTR2006-002670-22-CZ
(EUCTR)
29/08/200720/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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 RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy
41EUCTR2006-002670-22-HU
(EUCTR)
09/08/200704/07/2007Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESSComparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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 RecruitingFemale: yes
Male: yes
600Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
42EUCTR2006-002670-22-BE
(EUCTR)
25/07/200715/06/2007 Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS Ulcerative Colitis
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;Spain;Belgium;Germany;Italy;United Kingdom
43NCT00537316
(ClinicalTrials.gov)
July 200728/9/2007Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)Ulcerative ColitisBiological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusionMerck Sharp & Dohme Corp.NULLTerminated21 YearsN/AAll242Phase 3Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
44EUCTR2005-000695-40-GB
(EUCTR)
27/09/200517/08/2005A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trialA randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial The medical condition is Ulcerative Colitis.Product Name: products containing azathioprine or 6-mercaptopurine
INN or Proposed INN: azathioprine
INN or Proposed INN: azathioprine
INN or Proposed INN: 6-mercaptopurine
Product Name: Products containing aminosalicylate
INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum
University of NottinghamNULLNot Recruiting Female: yes
Male: yes
420 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom