97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000030988 | 2018/02/01 | 01/02/2018 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Open-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 Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | NULL | Pending | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan |
| 2 | NCT02954159 (ClinicalTrials.gov) | May 18, 2017 | 14/10/2016 | Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC | Induction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Tacrolimus;Drug: Vedolizumab;Other: Placebo | Medical College of Wisconsin | Takeda | Terminated | 18 Years | 65 Years | All | 4 | Phase 3 | United States |
| 3 | JPRN-UMIN000024936 | 2016/11/30 | 22/11/2016 | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis - Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis | Ulcerative colitis | patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml. | Keio University Gastroenterology and Hepatology | NULL | Recruiting | 16years-old | 150years-old | Male and Female | 30 | Not selected | Japan |
| 4 | JPRN-UMIN000015912 | 2014/12/15 | 15/12/2014 | Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus | Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus - Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus | ulcerative colitis | Tacrolimus will be decreased gradually three months after it was administered. Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually. | Osaka Medical College | NULL | Recruiting | 16years-old | 70years-old | Male and Female | 50 | Not applicable | Japan |
| 5 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 6 | JPRN-UMIN000013694 | 2014/05/13 | 11/04/2014 | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | ulcerative colitis | determine CYP3A5 SNP status increase the initial dosage of tacrolimus | Kitasato University Kitasato Institute Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 7 | JPRN-UMIN000013716 | 2014/04/15 | 15/04/2014 | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis - A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis | ulcerative colitis | After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy | Yokohama City University Medical Center | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 40 | Phase 2 | Japan |
| 8 | JPRN-UMIN000004201 | 2013/12/02 | 14/09/2010 | The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis | The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis - Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]: HOOP1 (TCL-UC)-3 [MHP] | The patients with moderate to severe active refractory ulcerative colitis | Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus, Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus, | Osaka City University, Graduate School of Medicine,Department of Gastroenterology | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 50 | Not selected | Japan |
| 9 | JPRN-UMIN000010776 | 2013/06/01 | 01/06/2013 | An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis | An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis - Tacrolimus versus cyclosporine treatment for severe UC | Ulcerative colitis | tacrolimus (Prograf) cyclosporine (Sandimmune) | Chiba University Hospital | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 40 | Not selected | Japan |
| 10 | JPRN-UMIN000010612 | 2013/05/01 | 01/05/2013 | A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis | A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis - A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis | Ulcerative colitis | Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks. | Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 130 | Phase 4 | Japan |
| 11 | NCT01418131 (ClinicalTrials.gov) | October 2012 | 15/8/2011 | Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | Ulcerative Colitis | Drug: Rectal tacrolimus;Drug: Placebo | The University of Western Australia | Royal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health Service | Completed | 18 Years | N/A | Both | 21 | Phase 4 | Australia |
| 12 | JPRN-UMIN000005824 | 2011/07/01 | 21/06/2011 | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis - Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis | ulcerative colitis | Tacrolimus (12weeks) | Juntendo University | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 20 | Not applicable | Japan |
| 13 | JPRN-UMIN000005033 | 2011/03/01 | 01/03/2011 | Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis | Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis - Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis | ulcerative colitis | Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week. | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 12years-old | 75years-old | Male and Female | 50 | Not applicable | Japan |
| 14 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | 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. | 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 colitis | 5-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 Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan |
| 15 | JPRN-UMIN000003952 | 2010/07/01 | 26/07/2010 | A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis | A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis - Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis | ulcerative colitis | Fasting condition group: Tacrolimus ingestion 1 hour before meal Fed condition group: Tacrolimus ingestion immediately following consumption of meal | Department of lower gastroenterology, Hyogo College of Medicine | Osaka Medical CollegeOsaka City University | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 40 | Phase 4 | Japan |
| 16 | NCT00347048 (ClinicalTrials.gov) | September 2006 | 30/6/2006 | Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Ulcerative Colitis | Drug: tacrolimus;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 62 | Phase 3 | Japan |
| 17 | NCT00643071 (ClinicalTrials.gov) | September 2006 | 20/3/2008 | Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study | Ulcerative Colitis | Drug: Tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 32 | Phase 3 | Japan |