ID

31843

Beskrivning

A Study of ARRY-438162 in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00650767

Länk

https://clinicaltrials.gov/show/NCT00650767

Nyckelord

Versioner (1)
  1. 2018-10-02 2018-10-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00650767

Engelsk

Eligibility Rheumatoid Arthritis NCT00650767

1 Formulär  
Criteria
Beskrivning

Criteria

diagnosis of rheumatoid arthritis, based on the american college of rheumatology (acr) 1987 revised criteria, prior to first dose of study drug.
Beskrivning

Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
Beskrivning

Methotrexate Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
Beskrivning

Folate Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178638
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
no prior use of biological agents for the treatment of rheumatoid arthritis.
Beskrivning

Biological agents Absent Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0003873
additional criteria exist.
Beskrivning

Inclusion criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
Beskrivning

Arthritis Interferes with Disease Assessment | Osteoarthritis Affecting Treatment Effectiveness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0087113
a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
Beskrivning

Kidney Disease Severe | Liver disease Severe | Hematological Disease Severe | Gastrointestinal Disease Severe | Endocrine System Disease Severe | Lung disease Severe | Heart Disease Severe | Nervous system disorder Severe | Kidney Disease Progressive | Liver disease Progressive | Hematological Disease Progressive | Gastrointestinal Disease Progressive | Endocrine System Disease Progressive | Lung disease Progressive | Heart Disease Progressive | Nervous system disorder Progressive | Kidney Disease Uncontrolled | Liver disease Uncontrolled | Hematological Disease Uncontrolled | Gastrointestinal Disease Uncontrolled | Endocrine System Disease Uncontrolled | Lung disease Uncontrolled | Heart Disease Uncontrolled | Nervous system disorder Uncontrolled | Rheumatoid arthritis with systemic involvement Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0018939
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0027765
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C0205329
UMLS CUI [10,1]
C0023895
UMLS CUI [10,2]
C0205329
UMLS CUI [11,1]
C0018939
UMLS CUI [11,2]
C0205329
UMLS CUI [12,1]
C0017178
UMLS CUI [12,2]
C0205329
UMLS CUI [13,1]
C0014130
UMLS CUI [13,2]
C0205329
UMLS CUI [14,1]
C0024115
UMLS CUI [14,2]
C0205329
UMLS CUI [15,1]
C0018799
UMLS CUI [15,2]
C0205329
UMLS CUI [16,1]
C0027765
UMLS CUI [16,2]
C0205329
UMLS CUI [17,1]
C0022658
UMLS CUI [17,2]
C0205318
UMLS CUI [18,1]
C0023895
UMLS CUI [18,2]
C0205318
UMLS CUI [19,1]
C0018939
UMLS CUI [19,2]
C0205318
UMLS CUI [20,1]
C0017178
UMLS CUI [20,2]
C0205318
UMLS CUI [21,1]
C0014130
UMLS CUI [21,2]
C0205318
UMLS CUI [22,1]
C0024115
UMLS CUI [22,2]
C0205318
UMLS CUI [23,1]
C0018799
UMLS CUI [23,2]
C0205318
UMLS CUI [24,1]
C0027765
UMLS CUI [24,2]
C0205318
UMLS CUI [25,1]
C0494896
UMLS CUI [25,2]
C0205082
additional criteria exist.
Beskrivning

Exclusion Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT00650767

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Rheumatoid Arthritis
Item
diagnosis of rheumatoid arthritis, based on the american college of rheumatology (acr) 1987 revised criteria, prior to first dose of study drug.
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dose Stable
Item
patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Folate Dose Stable
Item
patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
boolean
C0178638 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Biological agents Absent Rheumatoid Arthritis
Item
no prior use of biological agents for the treatment of rheumatoid arthritis.
boolean
C0005515 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Inclusion criteria Additional
Item
additional criteria exist.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthritis Interferes with Disease Assessment | Osteoarthritis Affecting Treatment Effectiveness
Item
diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0029408 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0087113 (UMLS CUI [2,3])
Kidney Disease Severe | Liver disease Severe | Hematological Disease Severe | Gastrointestinal Disease Severe | Endocrine System Disease Severe | Lung disease Severe | Heart Disease Severe | Nervous system disorder Severe | Kidney Disease Progressive | Liver disease Progressive | Hematological Disease Progressive | Gastrointestinal Disease Progressive | Endocrine System Disease Progressive | Lung disease Progressive | Heart Disease Progressive | Nervous system disorder Progressive | Kidney Disease Uncontrolled | Liver disease Uncontrolled | Hematological Disease Uncontrolled | Gastrointestinal Disease Uncontrolled | Endocrine System Disease Uncontrolled | Lung disease Uncontrolled | Heart Disease Uncontrolled | Nervous system disorder Uncontrolled | Rheumatoid arthritis with systemic involvement Severe
Item
a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018939 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0014130 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0027765 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0205329 (UMLS CUI [9,2])
C0023895 (UMLS CUI [10,1])
C0205329 (UMLS CUI [10,2])
C0018939 (UMLS CUI [11,1])
C0205329 (UMLS CUI [11,2])
C0017178 (UMLS CUI [12,1])
C0205329 (UMLS CUI [12,2])
C0014130 (UMLS CUI [13,1])
C0205329 (UMLS CUI [13,2])
C0024115 (UMLS CUI [14,1])
C0205329 (UMLS CUI [14,2])
C0018799 (UMLS CUI [15,1])
C0205329 (UMLS CUI [15,2])
C0027765 (UMLS CUI [16,1])
C0205329 (UMLS CUI [16,2])
C0022658 (UMLS CUI [17,1])
C0205318 (UMLS CUI [17,2])
C0023895 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C0018939 (UMLS CUI [19,1])
C0205318 (UMLS CUI [19,2])
C0017178 (UMLS CUI [20,1])
C0205318 (UMLS CUI [20,2])
C0014130 (UMLS CUI [21,1])
C0205318 (UMLS CUI [21,2])
C0024115 (UMLS CUI [22,1])
C0205318 (UMLS CUI [22,2])
C0018799 (UMLS CUI [23,1])
C0205318 (UMLS CUI [23,2])
C0027765 (UMLS CUI [24,1])
C0205318 (UMLS CUI [24,2])
C0494896 (UMLS CUI [25,1])
C0205082 (UMLS CUI [25,2])
Exclusion Criteria Additional
Item
additional criteria exist.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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