Apremilast 30 mg ( DrugBank: Apremilast )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 1 |
| 56 | ベーチェット病 | 4 |
| 107 | 若年性特発性関節炎 | 8 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | NCT01285310 (ClinicalTrials.gov) | December 9, 2010 | 19/11/2010 | Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Rheumatoid Arthritis | Drug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | N/A | All | 237 | Phase 2 | United States;Czechia;Poland;Spain;Czech Republic |
56. ベーチェット病
臨床試験数 : 81 / 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
| 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 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis | Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG 407 INN or Proposed INN: Apremilast | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland | ||
| 2 | EUCTR2019-002787-27-GR (EUCTR) | 20/05/2021 | 07/05/2021 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Israel;Netherlands;Switzerland | ||
| 3 | EUCTR2019-002787-27-FR (EUCTR) | 18/12/2020 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Israel;Netherlands;Switzerland | |||
| 4 | EUCTR2019-002787-27-NL (EUCTR) | 11/02/2021 | Apremilast study in children with active oral ulcers associated with Behçet’s Disease | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN) | Subjects with active Behçet’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Spain;Israel;Netherlands;United Kingdom;Switzerland;Italy |
107. 若年性特発性関節炎
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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 | EUCTR2022-003024-41-ES (EUCTR) | 25/01/2023 | 25/11/2022 | Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis | Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG 407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG 407 INN or Proposed INN: Apremilast | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Greece;Spain;Turkey;Israel;United Kingdom;Italy;Switzerland | ||
| 2 | EUCTR2019-002788-88-GR (EUCTR) | 14/04/2022 | 01/02/2022 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Poland;Belgium;Austria;Netherlands;Italy | ||
| 3 | EUCTR2019-002788-88-NL (EUCTR) | 23/09/2021 | 18/02/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands;Italy | ||
| 4 | EUCTR2019-002788-88-FR (EUCTR) | 15/04/2021 | 18/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Austria;Netherlands | ||
| 5 | EUCTR2019-002788-88-IT (EUCTR) | 11/03/2021 | 20/05/2021 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) - PEAPOD | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast 20 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE Product Name: Apremilast 30 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Trade Name: OTEZLA - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG Product Name: Apremilast 10 mg Product Code: [AMG407] INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: [AMG407] INN or Proposed INN: Apremilast | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Spain;Belgium;Austria;Netherlands;Germany;Italy | ||
| 6 | EUCTR2019-002788-88-AT (EUCTR) | 11/01/2021 | 05/11/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Greece;Poland;Belgium;Austria;Netherlands;Italy | ||
| 7 | EUCTR2019-002788-88-BE (EUCTR) | 15/12/2020 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | Belgium;Austria;Netherlands | |||
| 8 | EUCTR2019-002788-88-PL (EUCTR) | 28/01/2022 | Apremilast Study in Children with Active Juvenile Psoriatic Arthritis | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD) | Juvenile psoriatic arthritis MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Otezla Product Name: Apremilast 10 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 20 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Trade Name: Otezla Product Name: Apremilast 30 mg Product Code: AMG-407 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: AMG407 INN or Proposed INN: Apremilast | Amgen Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Belgium;Poland;Austria;Netherlands;Italy |