ID

25283

Description

Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00650156

Link

https://clinicaltrials.gov/show/NCT00650156

Keywords

Versions (1)
  1. 8/30/17 8/30/17 -
Uploaded on

August 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00650156

English

Eligibility Rheumatoid Arthritis NCT00650156

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female ages 18 years and older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
mild ra.
Description

Rheumatoid Arthritis Mild

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C2945599
body weight less than 100 kg.
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
wheelchair-bound or bedridden.
Description

Wheelchair bound | Bed-ridden

Data type

boolean

Alias
UMLS CUI [1]
C0558195
UMLS CUI [2]
C0425251
joint surgery involving joints to be assessed within this study, within two months prior to the screening visit.
Description

Operation on joint | Involvement with Clinical Trial Joints

Data type

boolean

Alias
UMLS CUI [1]
C0185132
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0022417
intra-articular, intramuscular or intravenous (iv) administration of corticosteroids within 28 days prior to the screening visit.
Description

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

Data type

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
prior treatment with any tnf antagonist, including adalimumab.
Description

Anti-tumor necrosis factor drug | adalimumab

Data type

boolean

Alias
UMLS CUI [1]
C1562242
UMLS CUI [2]
C1122087
positive tuberculin ppd 5.
Description

Mantoux positive

Data type

boolean

Alias
UMLS CUI [1]
C0032739
female subjects who are pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of hiv or of being immuno-compromised.
Description

HIV Infection | Immune system At risk

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0020962
UMLS CUI [2,2]
C1444641
history of malignancy.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
poorly controlled medical condition.
Description

Medical condition Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C3853134
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Similar models

Eligibility Rheumatoid Arthritis NCT00650156

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female ages 18 years and older.
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Mild
Item
mild ra.
boolean
C0003873 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
Body Weight
Item
body weight less than 100 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Wheelchair bound | Bed-ridden
Item
wheelchair-bound or bedridden.
boolean
C0558195 (UMLS CUI [1])
C0425251 (UMLS CUI [2])
Operation on joint | Involvement with Clinical Trial Joints
Item
joint surgery involving joints to be assessed within this study, within two months prior to the screening visit.
boolean
C0185132 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intra-articular, intramuscular or intravenous (iv) administration of corticosteroids within 28 days prior to the screening visit.
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])
Anti-tumor necrosis factor drug | adalimumab
Item
prior treatment with any tnf antagonist, including adalimumab.
boolean
C1562242 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
Mantoux positive
Item
positive tuberculin ppd 5.
boolean
C0032739 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection | Immune system At risk
Item
history of hiv or of being immuno-compromised.
boolean
C0019693 (UMLS CUI [1])
C0020962 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Malignant Neoplasms
Item
history of malignancy.
boolean
C0006826 (UMLS CUI [1])
Medical condition Poorly controlled
Item
poorly controlled medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
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