ID

19211

Description

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00235872

Link

https://clinicaltrials.gov/show/NCT00235872

Keywords

Versions (1)
  1. 12/12/16 12/12/16 -
Uploaded on

December 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00235872

English

Eligibility Rheumatoid Arthritis NCT00235872

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participation and completion until week 24 of the prior adalimumab dose-ranging study.
Description

Study Subject Participation Status | Clinical Trial adalimumab

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1122087
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.
Description

Gender Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Data type

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
female subjects tested negative in pregnancy test (serum test) at week 24 in prior adalimumab study, if capable of pregnancy.
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject who experienced any of the following during prior study:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
advanced or poorly controlled diabetes
Description

Diabetes Mellitus Advanced | Diabetes mellitus poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0860161
joint surgery (joint evaluated in this study)
Description

Operation on joint

Data type

boolean

Alias
UMLS CUI [1]
C0185132
a subject who has been prescribed excluded medications during prior study.
Description

Pharmaceutical Preparations Excluded prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0278329
history of following during prior study:
Description

Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0262926
clinically significant drug or alcohol abuse
Description

Substance Use Disorders Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2826293
intravenous (iv) drug abuse
Description

Intravenous Drug Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0086181
active infection with listeria or tuberculosis (tb)
Description

Listeriosis | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0023860
UMLS CUI [2]
C0041296
lymphoma, leukemia
Description

Lymphoma | leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0023418
and, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
Description

Malignant Neoplasms | Basal cell carcinoma Treated Successful

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
a subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
Description

Vaccines, Attenuated | Attenuated Vaccines Planned

Data type

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2,1]
C0042211
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Rheumatoid Arthritis NCT00235872

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Clinical Trial adalimumab
Item
participation and completion until week 24 of the prior adalimumab dose-ranging study.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1122087 (UMLS CUI [2,2])
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])
Childbearing Potential Serum pregnancy test negative
Item
female subjects tested negative in pregnancy test (serum test) at week 24 in prior adalimumab study, if capable of pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
criteria Fulfill
Item
a subject who experienced any of the following during prior study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
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])
Operation on joint
Item
joint surgery (joint evaluated in this study)
boolean
C0185132 (UMLS CUI [1])
Pharmaceutical Preparations Excluded prescribed
Item
a subject who has been prescribed excluded medications during prior study.
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
Medical History
Item
history of following during prior study:
boolean
C0262926 (UMLS CUI [1])
Substance Use Disorders Clinical Significance
Item
clinically significant drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Intravenous Drug Abuse
Item
intravenous (iv) drug abuse
boolean
C0086181 (UMLS CUI [1])
Listeriosis | Tuberculosis
Item
active infection with listeria or tuberculosis (tb)
boolean
C0023860 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Lymphoma | leukemia
Item
lymphoma, leukemia
boolean
C0024299 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma Treated Successful
Item
and, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
Vaccines, Attenuated | Attenuated Vaccines Planned
Item
a subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
boolean
C0042211 (UMLS CUI [1])
C0042211 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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