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
Showing 1 to 10 of 170 diseases
| 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 | NCT05442567 (ClinicalTrials.gov) | May 2, 2023 | 30/6/2022 | A Study of Vedolizumab in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) A Study of Vedolizumabin Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) ... | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ... | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab IV;Other: No Intervention | Takeda | NULL | Not yet recruiting | 3 Years | 17 Years | All | 240 | Phase 3 | NULL |
| 2 | EUCTR2021-000630-34-GR (EUCTR) | 13/01/2023 | 11/11/2022 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ... | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ... | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ... | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ... | ||
| 3 | EUCTR2021-000630-34-HR (EUCTR) | 27/12/2022 | 05/01/2023 | A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ... | A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ... | Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ... | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ... | ||
| 4 | EUCTR2022-000837-17-NL (EUCTR) | 07/12/2022 | 29/09/2022 | Lengthening of vedolizumab injections based on drug concentrations in patients with inflammatory bowel disease Lengthening of vedolizumabinjections based on drug concentrations in patients with inflammatory bowe ... | Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study - SILVER-study Subcutaneous vedolizumabdrug de-escalation using therapeutic drug monitoring in inflammatory bowel d ... | Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - D ... | Trade Name: Vedolizumab, Entyvio | Amsterdam UMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Netherlands | ||
| 5 | JPRN-jRCT2071210031 | 30/04/2022 | 01/06/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ... | Crohn's Disease | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >=30 kg will be included in this arm group Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this armgroup. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W Induction Period: Participants >=30 kg, Vedolizumab300 mg Vedolizumab300 mg, intravenous (IV) infusio ... | Shikamura Mitsuhiro | NULL | Recruiting | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania;New Zealand;Poland;Romania;Slovakia;Russia;Ukraine;Spain;United Kingdom;China;Japan United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania ... |
| 6 | NCT04804540 (ClinicalTrials.gov) | December 29, 2021 | 15/3/2021 | A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease | A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizu ... | Ulcerative Colitis;Crohn Disease | Drug: Vedolizumab IV | Takeda | NULL | Active, not recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | India |
| 7 | EUCTR2020-004301-31-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ... | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - - A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ... | Moderately to severely active Crohn's disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderately to severely active Crohn's disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ... | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO- 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - ... | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ... | ||
| 8 | EUCTR2020-004301-31-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ... | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ... | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ... | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovaki ... | ||
| 9 | EUCTR2020-004301-31-HR (EUCTR) | 17/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ... | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ... | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ... | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ... | ||
| 10 | EUCTR2020-004301-31-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ... | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ... | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ... | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ... | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ... |