ID

22976

Description

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00484289

Link

https://clinicaltrials.gov/show/NCT00484289

Keywords

Versions (1)
  1. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00484289

English

Eligibility Rheumatoid Arthritis NCT00484289

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participants who completed the 169 days, full study period of phase ii (im101-071) and were not administered other biologics between completion of im101-071 and registration of this long-term study.
Description

Study Subject Participation Status Clinical Trial Specified | Biological drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C0541491
the participants of the phase i study (im101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
Description

Study Subject Participation Status Clinical Trial Specified | abatacept

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C1619966
new subjects with mtx intolerance: rheumatoid arthritis (ra) patients to whom mtx cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (dmards;excluding mtx) or biologics (new subjects with mtx intolerance: ra patients who present an inadequate response to dmards).
Description

Intolerance to Methotrexate | Rheumatoid Arthritis | Antirheumatic Drugs, Disease-Modifying | Biological drugs | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0242708
UMLS CUI [4]
C0541491
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0205412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential (wocbp) who were unwilling or unable to use an acceptable method of contraception.
Description

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in japan) at registration.
Description

Biological drugs Non-Prescription | Biological drugs Investigational | abatacept

Data type

boolean

Alias
UMLS CUI [1,1]
C0541491
UMLS CUI [1,2]
C0013231
UMLS CUI [2,1]
C0541491
UMLS CUI [2,2]
C1517586
UMLS CUI [3]
C1619966
participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, d-penicillamine, cyclophosphamide, or immunoadsorption columns.
Description

leflunomide | mycophenolate mofetil | Calcineurin inhibitor | Cyclosporine | Tacrolimus | Penicillamine | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1]
C0063041
UMLS CUI [2]
C0209368
UMLS CUI [3]
C1562036
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0085149
UMLS CUI [6]
C0030817
UMLS CUI [7]
C0010583
the participants who completed phase ii (im101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (tb), with any opportunistic infections, laboratory values of hemoglobin < 8.5 g/dl, white blood cells (wbc) < 3,000/mm^3, platelets < 100,000/mm^3, serum creatinine > 2 times upper limit of normal (uln), serum alanine transaminase or aspartate aminotransferase > 2 times uln.
Description

Vasculitis | Kidney Diseases Severe Symptoms | Liver diseases Severe Symptoms | Hematological Disease Severe Symptoms | Gastrointestinal Diseases Severe Symptoms | Lung diseases Severe Symptoms | Heart Diseases Severe Symptoms | nervous system disorder Severe Symptoms | Cerebral disorder Severe Symptoms | Kidney Diseases Progressive Symptoms | Liver diseases Progressive Symptoms | Hematological Disease Progressive Symptoms | Gastrointestinal Diseases Progressive Symptoms | Lung diseases Progressive Symptoms | Heart Diseases Progressive Symptoms | nervous system disorder Progressive Symptoms | Cerebral disorder Progressive Symptoms | Kidney Diseases Uncontrolled Symptoms | Liver diseases Uncontrolled Symptoms | Hematological Disease Uncontrolled Symptoms | Gastrointestinal Diseases Uncontrolled Symptoms | Lung diseases Uncontrolled Symptoms | Heart Diseases Uncontrolled Symptoms | nervous system disorder Uncontrolled Symptoms | Cerebral disorder Uncontrolled Symptoms | Breast Carcinoma | Malignant Neoplasms | Bacterial Infections | Virus Disease | Bacterial Infection Latent | Virus Disease Latent | Communicable Disease Serious At risk Tuberculosis | Chronic infectious disease At risk Tuberculosis | Opportunistic Infections | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0042384
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1457887
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C1457887
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1457887
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C1457887
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C1457887
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C1457887
UMLS CUI [8,1]
C0027765
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C1457887
UMLS CUI [9,1]
C0234387
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C1457887
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205329
UMLS CUI [10,3]
C1457887
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205329
UMLS CUI [11,3]
C1457887
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205329
UMLS CUI [12,3]
C1457887
UMLS CUI [13,1]
C0017178
UMLS CUI [13,2]
C0205329
UMLS CUI [13,3]
C1457887
UMLS CUI [14,1]
C0024115
UMLS CUI [14,2]
C0205329
UMLS CUI [14,3]
C1457887
UMLS CUI [15,1]
C0018799
UMLS CUI [15,2]
C0205329
UMLS CUI [15,3]
C1457887
UMLS CUI [16,1]
C0027765
UMLS CUI [16,2]
C0205329
UMLS CUI [16,3]
C1457887
UMLS CUI [17,1]
C0234387
UMLS CUI [17,2]
C0205329
UMLS CUI [17,3]
C1457887
UMLS CUI [18,1]
C0022658
UMLS CUI [18,2]
C0205318
UMLS CUI [18,3]
C1457887
UMLS CUI [19,1]
C0023895
UMLS CUI [19,2]
C0205318
UMLS CUI [19,3]
C1457887
UMLS CUI [20,1]
C0018939
UMLS CUI [20,2]
C0205318
UMLS CUI [20,3]
C1457887
UMLS CUI [21,1]
C0017178
UMLS CUI [21,2]
C0205318
UMLS CUI [21,3]
C1457887
UMLS CUI [22,1]
C0024115
UMLS CUI [22,2]
C0205318
UMLS CUI [22,3]
C1457887
UMLS CUI [23,1]
C0018799
UMLS CUI [23,2]
C0205318
UMLS CUI [23,3]
C1457887
UMLS CUI [24,1]
C0027765
UMLS CUI [24,2]
C0205318
UMLS CUI [24,3]
C1457887
UMLS CUI [25,1]
C0234387
UMLS CUI [25,2]
C0205318
UMLS CUI [25,3]
C1457887
UMLS CUI [26]
C0678222
UMLS CUI [27]
C0006826
UMLS CUI [28]
C0004623
UMLS CUI [29]
C0042769
UMLS CUI [30,1]
C0004623
UMLS CUI [30,2]
C0205275
UMLS CUI [31,1]
C0042769
UMLS CUI [31,2]
C0205275
UMLS CUI [32,1]
C0009450
UMLS CUI [32,2]
C0205404
UMLS CUI [32,3]
C1444641
UMLS CUI [32,4]
C0041296
UMLS CUI [33,1]
C0151317
UMLS CUI [33,2]
C1444641
UMLS CUI [33,3]
C0041296
UMLS CUI [34]
C0029118
UMLS CUI [35]
C0518015
UMLS CUI [36]
C0023508
UMLS CUI [37]
C0032181
UMLS CUI [38]
C0700225
UMLS CUI [39]
C0151905
UMLS CUI [40]
C0151904
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Similar models

Eligibility Rheumatoid Arthritis NCT00484289

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status Clinical Trial Specified | Biological drugs
Item
the participants who completed the 169 days, full study period of phase ii (im101-071) and were not administered other biologics between completion of im101-071 and registration of this long-term study.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0541491 (UMLS CUI [2])
Study Subject Participation Status Clinical Trial Specified | abatacept
Item
the participants of the phase i study (im101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1619966 (UMLS CUI [2])
Intolerance to Methotrexate | Rheumatoid Arthritis | Antirheumatic Drugs, Disease-Modifying | Biological drugs | Response Inadequate
Item
new subjects with mtx intolerance: rheumatoid arthritis (ra) patients to whom mtx cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (dmards;excluding mtx) or biologics (new subjects with mtx intolerance: ra patients who present an inadequate response to dmards).
boolean
C1744706 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0242708 (UMLS CUI [3])
C0541491 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0205412 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
women of childbearing potential (wocbp) who were unwilling or unable to use an acceptable method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Biological drugs Non-Prescription | Biological drugs Investigational | abatacept
Item
participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in japan) at registration.
boolean
C0541491 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C0541491 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1619966 (UMLS CUI [3])
Investigational New Drugs
Item
participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest).
boolean
C0013230 (UMLS CUI [1])
leflunomide | mycophenolate mofetil | Calcineurin inhibitor | Cyclosporine | Tacrolimus | Penicillamine | Cyclophosphamide
Item
participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, d-penicillamine, cyclophosphamide, or immunoadsorption columns.
boolean
C0063041 (UMLS CUI [1])
C0209368 (UMLS CUI [2])
C1562036 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0085149 (UMLS CUI [5])
C0030817 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
Vasculitis | Kidney Diseases Severe Symptoms | Liver diseases Severe Symptoms | Hematological Disease Severe Symptoms | Gastrointestinal Diseases Severe Symptoms | Lung diseases Severe Symptoms | Heart Diseases Severe Symptoms | nervous system disorder Severe Symptoms | Cerebral disorder Severe Symptoms | Kidney Diseases Progressive Symptoms | Liver diseases Progressive Symptoms | Hematological Disease Progressive Symptoms | Gastrointestinal Diseases Progressive Symptoms | Lung diseases Progressive Symptoms | Heart Diseases Progressive Symptoms | nervous system disorder Progressive Symptoms | Cerebral disorder Progressive Symptoms | Kidney Diseases Uncontrolled Symptoms | Liver diseases Uncontrolled Symptoms | Hematological Disease Uncontrolled Symptoms | Gastrointestinal Diseases Uncontrolled Symptoms | Lung diseases Uncontrolled Symptoms | Heart Diseases Uncontrolled Symptoms | nervous system disorder Uncontrolled Symptoms | Cerebral disorder Uncontrolled Symptoms | Breast Carcinoma | Malignant Neoplasms | Bacterial Infections | Virus Disease | Bacterial Infection Latent | Virus Disease Latent | Communicable Disease Serious At risk Tuberculosis | Chronic infectious disease At risk Tuberculosis | Opportunistic Infections | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
the participants who completed phase ii (im101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (tb), with any opportunistic infections, laboratory values of hemoglobin < 8.5 g/dl, white blood cells (wbc) < 3,000/mm^3, platelets < 100,000/mm^3, serum creatinine > 2 times upper limit of normal (uln), serum alanine transaminase or aspartate aminotransferase > 2 times uln.
boolean
C0042384 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1457887 (UMLS CUI [3,3])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1457887 (UMLS CUI [4,3])
C0017178 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1457887 (UMLS CUI [5,3])
C0024115 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1457887 (UMLS CUI [6,3])
C0018799 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1457887 (UMLS CUI [7,3])
C0027765 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C1457887 (UMLS CUI [8,3])
C0234387 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C1457887 (UMLS CUI [9,3])
C0022658 (UMLS CUI [10,1])
C0205329 (UMLS CUI [10,2])
C1457887 (UMLS CUI [10,3])
C0023895 (UMLS CUI [11,1])
C0205329 (UMLS CUI [11,2])
C1457887 (UMLS CUI [11,3])
C0018939 (UMLS CUI [12,1])
C0205329 (UMLS CUI [12,2])
C1457887 (UMLS CUI [12,3])
C0017178 (UMLS CUI [13,1])
C0205329 (UMLS CUI [13,2])
C1457887 (UMLS CUI [13,3])
C0024115 (UMLS CUI [14,1])
C0205329 (UMLS CUI [14,2])
C1457887 (UMLS CUI [14,3])
C0018799 (UMLS CUI [15,1])
C0205329 (UMLS CUI [15,2])
C1457887 (UMLS CUI [15,3])
C0027765 (UMLS CUI [16,1])
C0205329 (UMLS CUI [16,2])
C1457887 (UMLS CUI [16,3])
C0234387 (UMLS CUI [17,1])
C0205329 (UMLS CUI [17,2])
C1457887 (UMLS CUI [17,3])
C0022658 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C1457887 (UMLS CUI [18,3])
C0023895 (UMLS CUI [19,1])
C0205318 (UMLS CUI [19,2])
C1457887 (UMLS CUI [19,3])
C0018939 (UMLS CUI [20,1])
C0205318 (UMLS CUI [20,2])
C1457887 (UMLS CUI [20,3])
C0017178 (UMLS CUI [21,1])
C0205318 (UMLS CUI [21,2])
C1457887 (UMLS CUI [21,3])
C0024115 (UMLS CUI [22,1])
C0205318 (UMLS CUI [22,2])
C1457887 (UMLS CUI [22,3])
C0018799 (UMLS CUI [23,1])
C0205318 (UMLS CUI [23,2])
C1457887 (UMLS CUI [23,3])
C0027765 (UMLS CUI [24,1])
C0205318 (UMLS CUI [24,2])
C1457887 (UMLS CUI [24,3])
C0234387 (UMLS CUI [25,1])
C0205318 (UMLS CUI [25,2])
C1457887 (UMLS CUI [25,3])
C0678222 (UMLS CUI [26])
C0006826 (UMLS CUI [27])
C0004623 (UMLS CUI [28])
C0042769 (UMLS CUI [29])
C0004623 (UMLS CUI [30,1])
C0205275 (UMLS CUI [30,2])
C0042769 (UMLS CUI [31,1])
C0205275 (UMLS CUI [31,2])
C0009450 (UMLS CUI [32,1])
C0205404 (UMLS CUI [32,2])
C1444641 (UMLS CUI [32,3])
C0041296 (UMLS CUI [32,4])
C0151317 (UMLS CUI [33,1])
C1444641 (UMLS CUI [33,2])
C0041296 (UMLS CUI [33,3])
C0029118 (UMLS CUI [34])
C0518015 (UMLS CUI [35])
C0023508 (UMLS CUI [36])
C0032181 (UMLS CUI [37])
C0700225 (UMLS CUI [38])
C0151905 (UMLS CUI [39])
C0151904 (UMLS CUI [40])
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