ID

19194

Beschreibung

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00235833

Link

https://clinicaltrials.gov/show/NCT00235833

Stichworte

Versionen (1)
  1. 12.12.16 12.12.16 -
Hochgeladen am

12. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00235833

Englisch

Eligibility Rheumatoid Arthritis NCT00235833

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participation in the prior adalimumab study
Beschreibung

Study Subject Participation Status Clinical Trial adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1122087
body weight less than 100 kg.
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
subject's who wished to continue the study drug administration
Beschreibung

Investigational New Drug Administration Continue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0549178
females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
Beschreibung

Gender Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject who experienced any of the following during the prior adalimumab sc dosing study:
Beschreibung

Clinical Trial adalimumab subcutaneous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1122087
UMLS CUI [1,3]
C1522438
advanced or poorly controlled diabetes
Beschreibung

Diabetes Mellitus Advanced | Diabetes mellitus poor control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0860161
any poorly controlled medical condition
Beschreibung

Medical condition Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C3853134
intra-articular, intramuscular or iv administration of corticosteroids
Beschreibung

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

Datentyp

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
joint surgery.
Beschreibung

Operation on joint

Datentyp

boolean

Alias
UMLS CUI [1]
C0185132
a subject who has been prescribed excluded medications during previous adalimumab study.
Beschreibung

Pharmaceutical Preparations Excluded prescribed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0278329
history of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (tb), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
Beschreibung

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

Datentyp

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
a subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
Beschreibung

Chronic infectious disease | Communicable Disease | Communicable Disease Episode Major | Hospitalization Required | Antibiotics Intravenous Patient need for | Antibiotics Oral chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C0205164
UMLS CUI [4]
C1708385
UMLS CUI [5,1]
C0003232
UMLS CUI [5,2]
C1522726
UMLS CUI [5,3]
C0686904
UMLS CUI [6,1]
C0003232
UMLS CUI [6,2]
C1527415
UMLS CUI [6,3]
C0205191
preexisting or recent onset of central nervous system (cns) demyelinating disorders.
Beschreibung

Demyelinating disease of central nervous system Pre-existing | Demyelinating disease of central nervous system Onset Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011302
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0011302
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0332185
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00235833

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status Clinical Trial adalimumab
Item
participation in the prior adalimumab study
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1122087 (UMLS CUI [1,3])
Body Weight
Item
body weight less than 100 kg.
boolean
C0005910 (UMLS CUI [1])
Investigational New Drug Administration Continue
Item
subject's who wished to continue the study drug administration
boolean
C0013230 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Gender Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
boolean
C0079399 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Clinical Trial adalimumab subcutaneous
Item
a subject who experienced any of the following during the prior adalimumab sc dosing study:
boolean
C0008976 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
C1522438 (UMLS CUI [1,3])
Diabetes Mellitus Advanced | Diabetes mellitus poor control
Item
advanced or poorly controlled diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0860161 (UMLS CUI [2])
Medical condition Poorly controlled
Item
any poorly controlled medical condition
boolean
C3843040 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intra-articular, intramuscular or iv administration of corticosteroids
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])
Operation on joint
Item
joint surgery.
boolean
C0185132 (UMLS CUI [1])
Pharmaceutical Preparations Excluded prescribed
Item
a subject who has been prescribed excluded medications during previous adalimumab study.
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
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, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (tb), lymphoma, leukemia, or 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])
Chronic infectious disease | Communicable Disease | Communicable Disease Episode Major | Hospitalization Required | Antibiotics Intravenous Patient need for | Antibiotics Oral chronic
Item
a subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
C0003232 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C0686904 (UMLS CUI [5,3])
C0003232 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0205191 (UMLS CUI [6,3])
Demyelinating disease of central nervous system Pre-existing | Demyelinating disease of central nervous system Onset Recent
Item
preexisting or recent onset of central nervous system (cns) demyelinating disorders.
boolean
C0011302 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0011302 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
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