ID

37069

Description

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

Link

https://clinicaltrials.gov/show/NCT02030028

Keywords

Versions (1)
  1. 7/1/19 7/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02030028

English

Eligibility Rheumatoid Arthritis NCT02030028

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 year of age and older
Description

Age

Data type

boolean

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

Rheumatoid Arthritis

Data type

boolean

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

Disease Clinical disease activity index CDAI

Data type

boolean

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

Biological agents

Data type

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
Description

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

Data type

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
Description

Absence Communicable Disease Requirement Antibiotics

Data type

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)
Description

Therapy Rheumatoid Arthritis | Methotrexate Dose Stable

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Description

Age

Data type

boolean

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

Informed Consent Unable | Informed Consent Unwilling

Data type

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
Description

Communicable Disease Requirement Antibiotics

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
abnormal renal function
Description

Abnormal renal function

Data type

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.
Description

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

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

Eligibility Rheumatoid Arthritis NCT02030028

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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