ID

31853

Description

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521); ODM derived from: https://clinicaltrials.gov/show/NCT00724672

Link

https://clinicaltrials.gov/show/NCT00724672

Keywords

Versions (1)
  1. 10/4/18 10/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00724672

English

Eligibility Rheumatoid Arthritis NCT00724672

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have active ra (das28 >5.1)
Description

Rheumatoid Arthritis Disease activity score das28

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C4481729
must have x-ray evidence of an erosive disease,
Description

Bone erosion X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0587240
UMLS CUI [1,2]
C0034571
must be eligible for but have never received any anti-tnf treatment,
Description

Patient Eligible Anti-TNF therapy | Anti-TNF therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0281481
UMLS CUI [2,1]
C0281481
UMLS CUI [2,2]
C0332197
must fulfill the 1987 criteria of the american college of rheumatology classification criteria for a diagnosis of ra, for at least 3 months,
Description

ACR Criteria Fulfill Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0003873
must have failed standard therapy (methotrexate or leflunomide).
Description

Standard therapy failed | Methotrexate | leflunomide

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0063041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
must not be a women who is pregnant or breastfeeding,
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
must not have a history of any malignancy,
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
must not have an active infection,
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
must not be prone to infection,
Description

Susceptibility Communicable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0220898
UMLS CUI [1,2]
C0009450
must not have tuberculosis, hepatitis b, hepatitis c, or hiv,
Description

Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
must not have septic arthritis of a native prosthetic joint within the last 12 months,
Description

Arthritis, Infectious | Joint Prosthesis Native

Data type

boolean

Alias
UMLS CUI [1]
C0003869
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C0175649
UMLS CUI [2,3]
C0302891
must not have nyha grade 3 or 4 heart failure,
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
must not have a history of demyelinating disease or systemic lupus erythematosis.
Description

Demyelinating Disease | Lupus Erythematosus, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0011303
UMLS CUI [2]
C0024141
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Similar models

Eligibility Rheumatoid Arthritis NCT00724672

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Disease activity score das28
Item
must have active ra (das28 >5.1)
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Bone erosion X-ray
Item
must have x-ray evidence of an erosive disease,
boolean
C0587240 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Patient Eligible Anti-TNF therapy | Anti-TNF therapy Absent
Item
must be eligible for but have never received any anti-tnf treatment,
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0281481 (UMLS CUI [1,3])
C0281481 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ACR Criteria Fulfill Rheumatoid Arthritis
Item
must fulfill the 1987 criteria of the american college of rheumatology classification criteria for a diagnosis of ra, for at least 3 months,
boolean
C3273747 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Standard therapy failed | Methotrexate | leflunomide
Item
must have failed standard therapy (methotrexate or leflunomide).
boolean
C2936643 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2])
C0063041 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
must not be a women who is pregnant or breastfeeding,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms
Item
must not have a history of any malignancy,
boolean
C0006826 (UMLS CUI [1])
Communicable Disease
Item
must not have an active infection,
boolean
C0009450 (UMLS CUI [1])
Susceptibility Communicable Disease
Item
must not be prone to infection,
boolean
C0220898 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
must not have tuberculosis, hepatitis b, hepatitis c, or hiv,
boolean
C0041296 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
Arthritis, Infectious | Joint Prosthesis Native
Item
must not have septic arthritis of a native prosthetic joint within the last 12 months,
boolean
C0003869 (UMLS CUI [1])
C0022417 (UMLS CUI [2,1])
C0175649 (UMLS CUI [2,2])
C0302891 (UMLS CUI [2,3])
Heart failure New York Heart Association Classification
Item
must not have nyha grade 3 or 4 heart failure,
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Demyelinating Disease | Lupus Erythematosus, Systemic
Item
must not have a history of demyelinating disease or systemic lupus erythematosis.
boolean
C0011303 (UMLS CUI [1])
C0024141 (UMLS CUI [2])
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