ID

37069

Descrição

ACTH Gel Therapy in Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02030028

Link

https://clinicaltrials.gov/show/NCT02030028

Palavras-chave

  1. 01/07/2019 01/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

1 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT02030028

Eligibility Rheumatoid Arthritis NCT02030028

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 year of age and older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ra diagnosis by american college of rheumatology criteria
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
active disease (cdai > 10)
Descrição

Disease Clinical disease activity index CDAI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3870066
have received at least are biologic agent for at least 6 months
Descrição

Biological agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005515
may or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
Descrição

Steroids Oral U/day | Prednisone Equivalent | Steroids Oral Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332197
no current active infections requiring antibiotics
Descrição

Absence Communicable Disease Requirement Antibiotics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0003232
patients must be on stable doses of ra therapies (e.g., methotrexate or other ra therapies for at least 4 weeks prior to baseline visit)
Descrição

Therapy Rheumatoid Arthritis | Methotrexate Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
unable or unwilling to give informed consent
Descrição

Informed Consent Unable | Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
have an active infection requiring the use of antibiotics
Descrição

Communicable Disease Requirement Antibiotics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
women who are pregnant
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
uncontrolled hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
abnormal renal function
Descrição

Abnormal renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151746
abnormal liver function as defined by and increased alanine transaminase (alt,) and aspartate aminotransferase (ast) that is greater than 5 times normal.
Descrição

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904

Similar models

Eligibility Rheumatoid Arthritis NCT02030028

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 year of age and older
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
ra diagnosis by american college of rheumatology criteria
boolean
C0003873 (UMLS CUI [1])
Disease Clinical disease activity index CDAI
Item
active disease (cdai > 10)
boolean
C0012634 (UMLS CUI [1,1])
C3870066 (UMLS CUI [1,2])
Biological agents
Item
have received at least are biologic agent for at least 6 months
boolean
C0005515 (UMLS CUI [1])
Steroids Oral U/day | Prednisone Equivalent | Steroids Oral Absent
Item
may or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0038317 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Absence Communicable Disease Requirement Antibiotics
Item
no current active infections requiring antibiotics
boolean
C0332197 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0003232 (UMLS CUI [1,4])
Therapy Rheumatoid Arthritis | Methotrexate Dose Stable
Item
patients must be on stable doses of ra therapies (e.g., methotrexate or other ra therapies for at least 4 weeks prior to baseline visit)
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Communicable Disease Requirement Antibiotics
Item
have an active infection requiring the use of antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Pregnancy
Item
women who are pregnant
boolean
C0032961 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
abnormal liver function as defined by and increased alanine transaminase (alt,) and aspartate aminotransferase (ast) that is greater than 5 times normal.
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])

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