Abatacept subcutaneous (DrugBank: Abatacept)
26 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 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
19 | ライソゾーム病 | 0 |
41 | 巨細胞性動脈炎 | 0 |
44 | 多発血管炎性肉芽腫症 | 0 |
46 | 悪性関節リウマチ | 7 |
49 | 全身性エリテマトーデス | 0 |
50 | 皮膚筋炎/多発性筋炎 | 2 |
51 | 全身性強皮症 | 0 |
53 | シェーグレン症候群 | 1 |
55 | 再発性多発軟骨炎 | 0 |
60 | 再生不良性貧血 | 0 |
65 | 原発性免疫不全症候群 | 0 |
84 | サルコイドーシス | 0 |
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 0 |
95 | 自己免疫性肝炎 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
107 | 若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)] | 0 |
160 | 先天性魚鱗癬 | 0 |
164 | 眼皮膚白皮症 | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
271 | 強直性脊椎炎 | 0 |
284 | ダイアモンド・ブラックファン貧血 | 0 |
285 | ファンコニ貧血 | 0 |
300 | IgG4関連疾患 | 0 |
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-JapicCTI-153081 | 01/8/2015 | 26/11/2015 | Effects of Abatacept in Patients With Early Rheumatoid Arthritis | A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive | Rheumatoid Arthritis | Intervention name : Abatacept + Methotrexate Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Control intervention name : Methotrexate Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally Control intervention name : Abatacept Placebo Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week Control intervention name : Methotrexate Placebo Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week | Bristol-Myers Squibb K.K. | NULL | complete | 18 | BOTH | 1000 | Phase 3 | NULL | |
2 | NCT01142726 (ClinicalTrials.gov) | December 2010 | 3/6/2010 | Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA | Rheumatoid Arthritis | Drug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 511 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway |
3 | EUCTR2010-018674-20-DE (EUCTR) | 05/11/2010 | 17/08/2010 | Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA) | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 3b | United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden | ||
4 | EUCTR2010-018674-20-DK (EUCTR) | 05/11/2010 | 21/09/2010 | Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA) | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 3b | United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Denmark;Australia;South Africa;Germany;Korea, Republic of;Sweden | ||
5 | EUCTR2010-018674-20-FI (EUCTR) | 13/10/2010 | 23/08/2010 | Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA) | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01. | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 3b | United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden | ||
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 |
6 | EUCTR2010-018674-20-BE (EUCTR) | 23/09/2010 | 19/08/2010 | Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination with Methotrexate in Adults with very early Rheumatoid Arthritis (RA) | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating protocol amendment 01 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 3 | United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden | ||
7 | EUCTR2010-018674-20-SE (EUCTR) | 16/09/2010 | 20/08/2010 | Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA) | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01 | Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 3b | France;United States;Mexico;Canada;Finland;Denmark;Australia;Russian Federation;Germany;Italy;Korea, Republic of;Sweden |
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 | NCT02971683 (ClinicalTrials.gov) | March 13, 2017 | 21/11/2016 | Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM) | Polymyositis;Dermatomyositis;Autoimmune Necrotizing Myopathy;Overlap Myositis;Juvenile Myositis Above the Age of 18 | Drug: Abatacept subcutaneous;Drug: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Sweden;Hungary |
2 | JPRN-JapicCTI-173670 | 01/3/2017 | 09/08/2017 | Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM) | Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18 | Intervention name : Abatacept INN of the intervention : Abatacept Dosage And administration of the intervention : Abatacept subcutaneous + Standard Treatment Control intervention name : Placebo Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment | Bristol-Myers Squibb K.K. | NULL | recruiting | 18 | BOTH | 150 | Phase 3 | NULL |
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-JapicCTI-173521 | 01/2/2017 | 24/02/2017 | A Phase 3 study of Abatacept in Patients with Primary Sjogrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens Syndrome | Primary Sjogrens Syndrome | Intervention name : Abatacept INN of the intervention : Abatacept Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week Control intervention name : Abatacept Placebo Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week | Bristol-Myers Squibb K.K. | NULL | complete | 18 | BOTH | 172 | Phase 3 | NULL |