Abatacept placebo ( DrugBank: Abatacept )


2 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3
53シェーグレン症候群1

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-153081
26/11/201526/11/2015Effects of Abatacept in Patients With Early Rheumatoid ArthritisA 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 ArthritisIntervention name : Abatacept + Methotrexate
INN of the intervention : 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
INN of the control intervention : Methotrexate
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
INN of the control intervention : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
INN of the control intervention : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week
Bristol-Myers Squibb K.K.ONO PHARMACEUTICAL CO., LTD.complete18BOTH1000Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
2NCT02504268
(ClinicalTrials.gov)
September 3, 201520/7/2015Effects of Abatacept in Patients With Early Rheumatoid ArthritisA 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 NaiveRheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/AAll994Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates
3NCT01142726
(ClinicalTrials.gov)
December 20103/6/2010Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid ArthritisA 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 RARheumatoid ArthritisDrug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placeboBristol-Myers SquibbNULLCompleted18 YearsN/AAll511Phase 3United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway

53. シェーグレン症候群


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-173521
01/2/201724/02/2017A Phase 3 study of Abatacept in Patients with Primary Sjogrens SyndromeA 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 SyndromeIntervention 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.NULLcomplete18BOTH172Phase 3NULL