96. クローン病 Crohn disease Clinical trials / Disease details
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. | 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-jRCT2031220309 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease - DUET-CD | Crohn's Disease | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 715 | Phase 2 | Argentina;Australia;Austria;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;China;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Serbia;Japan |
| 2 | JPRN-jRCT2031220205 | 22/08/2022 | 08/07/2022 | A Study of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease | A Phase 3,Randomized,Placebo-controlled,Parallel-group,Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease - FUZION CD | Fistulizing Crohns Disease Perianal Crohns Disease | Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumab will be administered subcutaneously/IV infusion. Placebo:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Matching placebo will be administered subcutaneously/IV infusion. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | Not applicable | Both | 280 | Phase 3 | Australia;Spain;Italy;Saudi Arabia;Belgium;France;Jordan;Sweden;Canada;United Kingdom Of Great Britain;Republic Of Korea;Turkey;Czechia;Greece;Netherlands;Taiwan;Germany;Hungary;Poland;United States Of America;Egypt;Israel;Portugal;Japan |
| 3 | JPRN-jRCT2031210678 | 22/08/2022 | 18/03/2022 | A Study of Guselkumab Subcutaneous Therapy in Participants with Moderately to Severely Active Crohn's Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease - GRAVITI | Crohn Disease | Guselkumab Dose 1:Drug:Group 1: Guselkumab,Group 2: Guselkumab:Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab Dose 2:Drug:Group 1: Guselkumab:Guselkumab (Dose 2) will be administered by SC injection. Guselkumab Dose 3:Drug:Group 2: Guselkumab:Guselkumab (Dose 3) will be administered by SC injection. Placebo:Drug:Group 3: Placebo:Placebo will be administered by SC injection. | Hirotaka Numaguchi | NULL | Pending | >= 18age old | Not applicable | Both | 318 | Phase 3 | Australia;Belarus;Belgium;Bosnia And Herzegovina;Brazil;Canada;China;Croatia;Czechia;Germany;Hungary;Italy;Jordan;Korea;France;Lithuania;Netherlands;NewZealand;Poland;RussianFederation;Serbia;Slovakia;Spain;Taiwan,Province Of China;Turkey;Ukraine;United Kingdom Of Great Britain;UnitedStates Of America;Japan |
| 4 | JPRN-jRCT2031220186 | 10/08/2022 | 06/07/2022 | A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) | Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis | Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection. | Nishikawa Kazuko | NULL | Pending | >= 2age old | < 18age old | Both | 151 | Phase 3 | France;Poland;United States Of America;Japan |
| 5 | ChiCTR2200058343 | 2022-04-13 | 2022-04-07 | To investigate the effect of pancreatin on diarrhea of crohn's disease patients taking total enteral nutrition | To investigate the effect of pancreatin on diarrhea of crohn's disease patients taking total enteral nutrition | Crohn's disease | Experimental group:Take trypsin medications; | Renmin Hospital of Wuhan University | NULL | Pending | 18 | 75 | Both | Experimental group:53; | Phase 4 | China |
| 6 | ChiCTR2200058055 | 2022-04-01 | 2022-03-27 | A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease | A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease | Inflammatory bowel disease (IBD) | Hemienteral nutrition group:adalimumab biological analogues combined with partial enteral nutrition therapy;Internal nutrition group:adalimumab combined with total enteral nutrition;The adamumab group:adalimumab; | The First Affiliated Hospital of Shantou University Medical College | NULL | Pending | 18 | 75 | Both | Hemienteral nutrition group:30;Internal nutrition group:30;The adamumab group:60; | N/A | China |
| 7 | JPRN-jRCT2031210677 | 18/03/2022 | 18/03/2022 | A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn's Disease | fibrostenotic Crohn's Disease | Investigational Drug: Spesolimab, Placebo Dose: 1200 mg spesolimab or placebo every 4 weeks (Day 1 to Week 8), then 1200 mg spesolimab or placebo every 8 weeks until Week 40 Mode of Administration: intervenous | Taguchi Aya | NULL | Pending | >= 18age old | <= 75age old | Both | 3 | Phase 2 | Australia;Austria;Belgium;Brazil;Canada;China;Denmark;France;Germany;Ireland;Israel;Italy;Republic of Korea;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom;United States;Japan |
| 8 | ChiCTR2100048717 | 2021-07-01 | 2021-07-13 | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Crohn's disease | Two groups:Oral dipyridamole; | Guangzhou Women and Children's Medical Center | NULL | Pending | 3 | 18 | Both | Two groups:50; | China | |
| 9 | JPRN-UMIN000043165 | 2021/02/01 | 31/01/2021 | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Crohn's disease, Ulcerative colitis, IBDU | witching from originator infliximab to infliximab biosimilar CT-P13 | Fukuoka University Chikushi Hospital | NULL | Pending | Not applicable | Not applicable | Male and Female | 220 | Not selected | Japan |
| 10 | ChiCTR2000036845 | 2021-01-01 | 2020-08-25 | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | Crohn's disease | Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ; | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Proctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60; | Phase 4 | China |
| 11 | ChiCTR2000035737 | 2020-10-01 | 2020-08-16 | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Crohn's disease | Experimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience; | Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Experimental group:45;Control group:45; | China | |
| 12 | ChiCTR2000031344 | 2020-05-01 | 2020-03-28 | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Crohn's disease | Group 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection; | The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | Both | Group 1:35;Group 2:35; | China | |||
| 13 | ChiCTR2000029323 | 2020-03-01 | 2020-01-25 | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Crohn's disease | Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab; | Renji Hospital, School of Medicine, Shanghai Jiaotong University | NULL | Pending | 18 | 80 | Both | Experimental group:30;Control group:30; | China | |
| 14 | ChiCTR1900026091 | 2019-09-19 | 2019-09-20 | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study | Crohn's disease | Case series:infliximab; | The First Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 9 | 58 | Both | Case series:343; | China | |
| 15 | JPRN-JapicCTI-194830 | 01/7/2019 | 27/06/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's disease | Intervention name : Vedolizumab (Genetical Recombination) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | pending | BOTH | 300 | NA | Japan | ||
| 16 | ChiCTR1900023696 | 2019-07-01 | 2019-06-08 | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Chron's disease | Group 1:EBD;Group 2:EBD combined with local injection of betamethasone; | The Sixth Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 18 | 75 | Both | Group 1:45;Group 2:45; | N/A | China |
| 17 | ChiCTR1900022728 | 2019-05-01 | 2019-04-23 | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Crohn's disease | Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD; | The 7th Medical Center of the PLA General Hospital (Army general hospital) | NULL | Pending | Both | Target condition:310;Difficult condition:160 | China | |||
| 18 | EUCTR2018-003303-19-PL (EUCTR) | 15/03/2019 | 23/01/2019 | A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease. | A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHR0302 INN or Proposed INN: Pending | Reistone Biopharma Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Poland;Ukraine;China | ||
| 19 | ChiCTR1800015174 | 2018-05-01 | 2018-03-12 | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Crohn's disease | control group:placebo;Vitamin D:800IU Vitamin D; | Gudangdong General Hospital, Guangdong Academy of Medical Sciences | NULL | Pending | 18 | 75 | Both | control group:32;Vitamin D:32; | China |