Subcutaneous abatacept (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 | 1 |
| 44 | 多発血管炎性肉芽腫症 | 0 |
| 46 | 悪性関節リウマチ | 8 |
| 49 | 全身性エリテマトーデス | 0 |
| 50 | 皮膚筋炎／多発性筋炎 | 0 |
| 51 | 全身性強皮症 | 2 |
| 53 | シェーグレン症候群 | 5 |
| 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 | 3 |
| 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 | NCT03192969 (ClinicalTrials.gov) | July 15, 2017 | 14/6/2017 | A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA) | A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Abatacept;Other: Placebo;Drug: Glucocorticoid Treatment | Bristol-Myers Squibb | NULL | Withdrawn | 50 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Denmark;Estonia;France;Germany;Greece;Ireland;Italy;Netherlands;Poland;Romania;Serbia;Spain;Sweden;Switzerland;United Kingdom |
| 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 | NCT02557100 (ClinicalTrials.gov) | November 19, 2015 | 4/9/2015 | Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis | A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 80 | Phase 4 | United States;Canada;Mexico;Algeria |
| 2 | NCT02598466 (ClinicalTrials.gov) | July 2015 | 4/11/2015 | Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa | Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa | Rheumatoid Arthritis | Drug: Abatacept | Bristol-Myers Squibb | Hexor, South Africa | Completed | 18 Years | N/A | Both | 69 | N/A | NULL |
| 3 | JPRN-UMIN000015175 | 2014/07/01 | 17/09/2014 | Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. | Rheumatoid Arthritis | Subcutaneous Tocilizumab 162mg every other week. Subcutaneous Abatacept 125mg every week. | St.Marianna University School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 120 | Not selected | Japan | |
| 4 | NCT02053727 (ClinicalTrials.gov) | July 2014 | 6/11/2013 | Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background | Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial. | Rheumatoid Arthritis;Chronic Hepatitis B | Drug: Abatacept;Drug: Placebo | University of California, Los Angeles | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United States |
| 5 | NCT01333878 (ClinicalTrials.gov) | March 2011 | 7/4/2011 | Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage | An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray | Rheumatoid Arthritis | Biological: Subcutaneous Abatacept | Orrin M Troum, M.D. and Medical Associates | Bristol-Myers Squibb | Completed | 18 Years | N/A | Both | 12 | Phase 2;Phase 3 | United States |
| 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 | NCT01299961 (ClinicalTrials.gov) | March 2011 | 18/2/2011 | Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis | Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: abatacept | University of California, Los Angeles | NULL | Completed | 18 Years | N/A | All | 25 | Phase 3 | United States |
| 7 | NCT00929864 (ClinicalTrials.gov) | October 2009 | 29/6/2009 | Abatacept Versus Adalimumab Head-to-Head | A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Abatacept;Drug: Adalimumab | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 869 | Phase 3 | United States;Argentina;Canada;Chile;Peru |
| 8 | NCT00547521 (ClinicalTrials.gov) | December 2007 | 19/10/2007 | Phase IIIB Subcutaneous Abatacept Monotherapy Study | A Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate | Rheumatoid Arthritis (RA) | Drug: abatacept;Drug: Methotrexate (MTX) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 119 | Phase 3 | United States;Australia;Mexico;South Africa;Brazil;Canada;Peru |
| 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 | EUCTR2014-005323-27-GB (EUCTR) | 16/09/2015 | 29/09/2015 | A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosis | A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET) | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 18.0;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | University of Michigan | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Canada;Italy;United Kingdom | |||
| 2 | NCT02161406 (ClinicalTrials.gov) | September 2014 | 3/6/2014 | A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis | A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial. | Diffuse Cutaneous Systemic Sclerosis | Drug: Abatacept;Drug: Placebo | Dinesh Khanna, MD, MS | Bristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID) | Completed | 18 Years | N/A | All | 88 | Phase 2 | United States;Canada;United Kingdom |
| 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 | EUCTR2016-001948-19-SE (EUCTR) | 02/02/2017 | 19/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 2 | 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 | |
| 3 | EUCTR2016-001948-19-CZ (EUCTR) | 28/12/2016 | 27/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | |||
| 4 | NCT02915159 (ClinicalTrials.gov) | December 6, 2016 | 23/9/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome | Sjogrens Disease | Biological: Abatacept;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 250 | Phase 3 | United States;Argentina;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Sweden;Canada;Czech Republic |
| 5 | EUCTR2016-001948-19-FR (EUCTR) | 02/12/2016 | 07/11/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of |
| 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 | EUCTR2016-001948-19-SE (EUCTR) | 02/02/2017 | 19/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2016-001948-19-CZ (EUCTR) | 28/12/2016 | 27/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | |||
| 3 | EUCTR2016-001948-19-FR (EUCTR) | 02/12/2016 | 07/11/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of |