ID

19204

Descrição

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00235859

Link

https://clinicaltrials.gov/show/NCT00235859

Palavras-chave

Versões (1)
  1. 12/12/2016 12/12/2016 -
Transferido a

12 de dezembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00235859

Inglês

Eligibility Rheumatoid Arthritis NCT00235859

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet acr criteria for diagnosis of active ra and have at >6 swollen joints and >9 tender joints
Descrição

Rheumatoid Arthritis | Joint swelling Quantity | Joints tender Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0152031
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0240094
UMLS CUI [3,2]
C1265611
subjects must have received at least one prior dmard besides mtx, but may have had efficacy failures on no more than four standard dmards other than mtx
Descrição

Disease-Modifying Antirheumatic Drugs Quantity | Effectiveness failed Quantity | Methotrexate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1280519
UMLS CUI [2,2]
C0231175
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0025677
therapy with mtx for at least 6 months prior to screening and on a stable dose of mtx for at least 4 weeks prior to screening visit
Descrição

Methotrexate Duration | Methotrexate Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
age 18 years and older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with any tnf antagonist, including adalimumab
Descrição

Tumor necrosis factor alpha (TNF-) inhibitors | adalimumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3653350
UMLS CUI [2]
C1122087
history of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (tb), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
Descrição

Substance Use Disorders Clinical Significance | Intravenous Drug Abuse | Listeriosis | Tuberculosis | Lymphoma | leukemia | Malignant Neoplasms | Basal cell carcinoma Treated Successful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0086181
UMLS CUI [3]
C0023860
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0024299
UMLS CUI [6]
C0023418
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C0007117
UMLS CUI [8,2]
C1522326
UMLS CUI [8,3]
C1272703
subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-cd4 antibody, within 6 months prior to the screening evaluation, prior treatment with any tnf antagonist, including adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
Descrição

Vaccines, Attenuated | Investigational New Drugs | Biological Factors Investigational | Anti-CD4 Monoclonal Antibody | Tumor necrosis factor alpha (TNF-) inhibitors | adalimumab | Exposure to Alkylating Agents | Exposure to Chlorambucil | Exposure to Cyclophosphamide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C1517586
UMLS CUI [4]
C3831519
UMLS CUI [5]
C3653350
UMLS CUI [6]
C1122087
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0002073
UMLS CUI [8,1]
C0332157
UMLS CUI [8,2]
C0008163
UMLS CUI [9,1]
C0332157
UMLS CUI [9,2]
C0010583
chest x-ray with calcified granuloma and/or pleural scarring
Descrição

Calcified granuloma Plain chest X-ray | Pleural scarring Plain chest X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0333404
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0577703
UMLS CUI [2,2]
C0039985
positive tb skin test, rt23 dose skin test, >5 mm at 48 to 72 hours
Descrição

TB skin test result Positive | Tuberculin Test Purified protein derivative - RT23

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0848706
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0041290
UMLS CUI [2,2]
C0444605
unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
Descrição

Myocardial Ischemia Unstable | Inflammatory Bowel Diseases | Peptic Ulcer | Cerebrovascular accident Recent | Medical condition Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0030920
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C3853134
intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
Descrição

intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
female who is pregnant or breast-feeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Rheumatoid Arthritis NCT00235859

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Joint swelling Quantity | Joints tender Quantity
Item
meet acr criteria for diagnosis of active ra and have at >6 swollen joints and >9 tender joints
boolean
C0003873 (UMLS CUI [1])
C0152031 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0240094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Disease-Modifying Antirheumatic Drugs Quantity | Effectiveness failed Quantity | Methotrexate
Item
subjects must have received at least one prior dmard besides mtx, but may have had efficacy failures on no more than four standard dmards other than mtx
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1280519 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3])
Methotrexate Duration | Methotrexate Dose Stable
Item
therapy with mtx for at least 6 months prior to screening and on a stable dose of mtx for at least 4 weeks prior to screening visit
boolean
C0025677 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age
Item
age 18 years and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor necrosis factor alpha (TNF-) inhibitors | adalimumab
Item
prior treatment with any tnf antagonist, including adalimumab
boolean
C3653350 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
Substance Use Disorders Clinical Significance | Intravenous Drug Abuse | Listeriosis | Tuberculosis | Lymphoma | leukemia | Malignant Neoplasms | Basal cell carcinoma Treated Successful
Item
history of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (tb), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
boolean
C0038586 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0086181 (UMLS CUI [2])
C0023860 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0024299 (UMLS CUI [5])
C0023418 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0007117 (UMLS CUI [8,1])
C1522326 (UMLS CUI [8,2])
C1272703 (UMLS CUI [8,3])
Vaccines, Attenuated | Investigational New Drugs | Biological Factors Investigational | Anti-CD4 Monoclonal Antibody | Tumor necrosis factor alpha (TNF-) inhibitors | adalimumab | Exposure to Alkylating Agents | Exposure to Chlorambucil | Exposure to Cyclophosphamide
Item
subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-cd4 antibody, within 6 months prior to the screening evaluation, prior treatment with any tnf antagonist, including adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
boolean
C0042211 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0005515 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C3831519 (UMLS CUI [4])
C3653350 (UMLS CUI [5])
C1122087 (UMLS CUI [6])
C0332157 (UMLS CUI [7,1])
C0002073 (UMLS CUI [7,2])
C0332157 (UMLS CUI [8,1])
C0008163 (UMLS CUI [8,2])
C0332157 (UMLS CUI [9,1])
C0010583 (UMLS CUI [9,2])
Calcified granuloma Plain chest X-ray | Pleural scarring Plain chest X-ray
Item
chest x-ray with calcified granuloma and/or pleural scarring
boolean
C0333404 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0577703 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
TB skin test result Positive | Tuberculin Test Purified protein derivative - RT23
Item
positive tb skin test, rt23 dose skin test, >5 mm at 48 to 72 hours
boolean
C0848706 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0041290 (UMLS CUI [2,1])
C0444605 (UMLS CUI [2,2])
Myocardial Ischemia Unstable | Inflammatory Bowel Diseases | Peptic Ulcer | Cerebrovascular accident Recent | Medical condition Poorly controlled
Item
unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
boolean
C0151744 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0021390 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0038454 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C3843040 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
female who is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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