ID

31862

Description

Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT00791921

Link

https://clinicaltrials.gov/show/NCT00791921

Keywords

Versions (1)
  1. 10/5/18 10/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00791921

English

Eligibility Rheumatoid Arthritis NCT00791921

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have a diagnosis of adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria.
Description

Adult onset Rheumatoid Arthritis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1853562
UMLS CUI [1,2]
C0003873
UMLS CUI [1,3]
C0449238
subjects must have active ra disease as defined by:
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
at least 6 tender joints and 6 swollen joints
Description

Tender joint count | Swollen joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2]
C0451521
esr of 28 mm/hour or crp of 2.0 mg/dl
Description

Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C1176468
UMLS CUI [2]
C0201657
subjects who have failed to respond or have been resistant to at least one dmard (including mtx)
Description

DMARD Quantity Unresponsive to Treatment | DMARD Quantity Resistant | Methotrexate Unresponsive to Treatment | Methotrexate Resistant

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332325
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0025677
UMLS CUI [4,2]
C0332325
subjects in whom mtx cannot be administered for any of the reasons(incomplete response/safety concerns)
Description

Methotrexate Unsuccessful | Response Incomplete | Patient safety Concerns

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205257
UMLS CUI [3,1]
C1113679
UMLS CUI [3,2]
C2699424
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have a diagnosis of any other inflammatory arthritis
Description

Arthritis Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
Description

Arthritis Secondary Noninflammatory | Osteoarthritis | Fibromyalgia

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0442743
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0016053
patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
Description

Demyelinating disease of central nervous system | Convulsive disorder Central Nervous System | Multiple Sclerosis | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0011302
UMLS CUI [2,1]
C0234972
UMLS CUI [2,2]
C3714787
UMLS CUI [3]
C0026769
UMLS CUI [4]
C0014544
patients who have nyha (new york heart association) class iii or iv congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients who currently have, or who have a history of, tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
Description

High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205404
patients who currently have, or who have a history of, malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
female patients who are breastfeeding or pregnant, who are of childbearing potential
Description

Pregnancy | Breast Feeding | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
patients who previously received treatment with 2 or more anti-tnfα drugs or who previously failed to respond to treatment with 1 or more aint-tnfα drugs.
Description

Anti-TNF alpha drug Quantity | Anti-TNF alpha drug Quantity Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1562242
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205269
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Similar models

Eligibility Rheumatoid Arthritis NCT00791921

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult onset Rheumatoid Arthritis Duration
Item
subjects must have a diagnosis of adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria.
boolean
C1853562 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Rheumatoid Arthritis
Item
subjects must have active ra disease as defined by:
boolean
C0003873 (UMLS CUI [1])
Tender joint count | Swollen joint count
Item
at least 6 tender joints and 6 swollen joints
boolean
C0451530 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
esr of 28 mm/hour or crp of 2.0 mg/dl
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
DMARD Quantity Unresponsive to Treatment | DMARD Quantity Resistant | Methotrexate Unresponsive to Treatment | Methotrexate Resistant
Item
subjects who have failed to respond or have been resistant to at least one dmard (including mtx)
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0242708 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332325 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0025677 (UMLS CUI [4,1])
C0332325 (UMLS CUI [4,2])
Methotrexate Unsuccessful | Response Incomplete | Patient safety Concerns
Item
subjects in whom mtx cannot be administered for any of the reasons(incomplete response/safety concerns)
boolean
C0025677 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C1113679 (UMLS CUI [3,1])
C2699424 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Arthritis Other
Item
patients who have a diagnosis of any other inflammatory arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Arthritis Secondary Noninflammatory | Osteoarthritis | Fibromyalgia
Item
patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
boolean
C0003864 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0442743 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2])
C0016053 (UMLS CUI [3])
Demyelinating disease of central nervous system | Convulsive disorder Central Nervous System | Multiple Sclerosis | Epilepsy
Item
patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
boolean
C0011302 (UMLS CUI [1])
C0234972 (UMLS CUI [2,1])
C3714787 (UMLS CUI [2,2])
C0026769 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
Congestive heart failure New York Heart Association Classification
Item
patients who have nyha (new york heart association) class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tuberculosis
Item
patients who currently have, or who have a history of, tuberculosis
boolean
C0041296 (UMLS CUI [1])
High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious
Item
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Malignant Neoplasms
Item
patients who currently have, or who have a history of, malignancy
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential
Item
female patients who are breastfeeding or pregnant, who are of childbearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Anti-TNF alpha drug Quantity | Anti-TNF alpha drug Quantity Unresponsive to Treatment
Item
patients who previously received treatment with 2 or more anti-tnfα drugs or who previously failed to respond to treatment with 1 or more aint-tnfα drugs.
boolean
C1562242 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1562242 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
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