ID

22934

Description

Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00369928

Link

https://clinicaltrials.gov/show/NCT00369928

Keywords

Versions (1)
  1. 6/17/17 6/17/17 -
Uploaded on

June 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00369928

English

Eligibility Rheumatoid Arthritis NCT00369928

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet american college of rheumatology (acr) criteria for rheumatoid arthritis
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
disease duration of at least 6 months
Description

disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
must be treated with methotrexate for at least 24 weeks
Description

Methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C0025677
at least 6 swollen joints and 6 tender joints
Description

Swollen joint count | Tender joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
washout required for other disease modifying anti-rheumatic drugs (dmards)
Description

Antirheumatic Drugs, Disease-Modifying | Washout Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0686904
women of childbearing age and all males must use acceptable method of birth control
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
malignancies
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
abnormal electrocardiograms as described in the protocol
Description

Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
current infection or recurrent infections or immunodeficiency
Description

Communicable Disease | Recurrent infections | Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0239998
UMLS CUI [3]
C0021051
liver diseases and abnormalities in liver function tests as described in the protocol
Description

Liver diseases | Liver function tests abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151766
autoimmune diseases other than ra except sjogren's syndrome secondary to ra;
Description

Autoimmune Diseases | Rheumatoid Arthritis | Sjogren's Syndrome Secondary to Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C1527336
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0003873
history of demyelization diseases
Description

Demyelinating Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011303
any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
Description

Condition Study Subject Participation Status Unfavorable | Laboratory Results Changed status Important | Disease Changed status Important

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0443172
UMLS CUI [2,3]
C3898777
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0443172
UMLS CUI [3,3]
C3898777
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Similar models

Eligibility Rheumatoid Arthritis NCT00369928

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
meet american college of rheumatology (acr) criteria for rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1])
disease length
Item
disease duration of at least 6 months
boolean
C0872146 (UMLS CUI [1])
Methotrexate
Item
must be treated with methotrexate for at least 24 weeks
boolean
C0025677 (UMLS CUI [1])
Swollen joint count | Tender joint count
Item
at least 6 swollen joints and 6 tender joints
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Antirheumatic Drugs, Disease-Modifying | Washout Patient need for
Item
washout required for other disease modifying anti-rheumatic drugs (dmards)
boolean
C0242708 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of childbearing age and all males must use acceptable method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Tuberculosis
Item
tuberculosis
boolean
C0041296 (UMLS CUI [1])
Malignant Neoplasms
Item
malignancies
boolean
C0006826 (UMLS CUI [1])
Electrocardiogram abnormal
Item
abnormal electrocardiograms as described in the protocol
boolean
C0522055 (UMLS CUI [1])
Communicable Disease | Recurrent infections | Immunologic Deficiency Syndromes
Item
current infection or recurrent infections or immunodeficiency
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0021051 (UMLS CUI [3])
Liver diseases | Liver function tests abnormal
Item
liver diseases and abnormalities in liver function tests as described in the protocol
boolean
C0023895 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
Autoimmune Diseases | Rheumatoid Arthritis | Sjogren's Syndrome Secondary to Rheumatoid Arthritis
Item
autoimmune diseases other than ra except sjogren's syndrome secondary to ra;
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C1527336 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0003873 (UMLS CUI [3,3])
Demyelinating Diseases
Item
history of demyelization diseases
boolean
C0011303 (UMLS CUI [1])
Condition Study Subject Participation Status Unfavorable | Laboratory Results Changed status Important | Disease Changed status Important
Item
any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C1254595 (UMLS CUI [2,1])
C0443172 (UMLS CUI [2,2])
C3898777 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0443172 (UMLS CUI [3,2])
C3898777 (UMLS CUI [3,3])
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