ID

22970

Description

Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00425321

Link

https://clinicaltrials.gov/show/NCT00425321

Keywords

  1. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00425321

Eligibility Rheumatoid Arthritis NCT00425321

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
Description

Rheumatoid Arthritis disease length | Tender joint count | Swollen joint count

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
methotrexate treatment for 6 months
Description

Methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C0025677
at least 10mg/wk and stable dose for at least 8 weeks
Description

Dose Stable U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0560588
negative tb screening
Description

Tuberculosis test negative

Data type

boolean

Alias
UMLS CUI [1]
C2242735
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of other disease-modifying anti-rheumatic drugs (dmards) (other than methotrexate mtx)
Description

Antirheumatic Drugs, Disease-Modifying | Methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0025677
previous use of more than 1 anti-tnf (tumor necrosis factor) agent
Description

Anti-tumor necrosis factor alpha drug Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C1265611
previous use of cytotoxics, p38 mapkinase inhibitor, anti-cd4 antibody
Description

Cytotoxic agent | MAP kinase p38 inhibitor | Anti-CD4 Monoclonal Antibody

Data type

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2,1]
C1120843
UMLS CUI [2,2]
C0243077
UMLS CUI [3]
C3831519
receipt of live vaccine within 1 month of study drug
Description

Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
Description

Communicable Disease Serious | Chronic infectious disease | Recurrent infections | Opportunistic Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0239998
UMLS CUI [4]
C0029118
other clinically significant disease of other organ system
Description

Disease Clinical Significance Organ system

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0460002

Similar models

Eligibility Rheumatoid Arthritis NCT00425321

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis disease length | Tender joint count | Swollen joint count
Item
patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
Methotrexate
Item
methotrexate treatment for 6 months
boolean
C0025677 (UMLS CUI [1])
Dose Stable U/week
Item
at least 10mg/wk and stable dose for at least 8 weeks
boolean
C0178602 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
Tuberculosis test negative
Item
negative tb screening
boolean
C2242735 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antirheumatic Drugs, Disease-Modifying | Methotrexate
Item
use of other disease-modifying anti-rheumatic drugs (dmards) (other than methotrexate mtx)
boolean
C0242708 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
Anti-tumor necrosis factor alpha drug Quantity
Item
previous use of more than 1 anti-tnf (tumor necrosis factor) agent
boolean
C1562242 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Cytotoxic agent | MAP kinase p38 inhibitor | Anti-CD4 Monoclonal Antibody
Item
previous use of cytotoxics, p38 mapkinase inhibitor, anti-cd4 antibody
boolean
C0304497 (UMLS CUI [1])
C1120843 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C3831519 (UMLS CUI [3])
Vaccines, Attenuated
Item
receipt of live vaccine within 1 month of study drug
boolean
C0042211 (UMLS CUI [1])
Communicable Disease Serious | Chronic infectious disease | Recurrent infections | Opportunistic Infection
Item
serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151317 (UMLS CUI [2])
C0239998 (UMLS CUI [3])
C0029118 (UMLS CUI [4])
Disease Clinical Significance Organ system
Item
other clinically significant disease of other organ system
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,3])

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