ID

31840

Descrição

Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00639834

Link

https://clinicaltrials.gov/show/NCT00639834

Palavras-chave

Versões (1)
  1. 01/10/2018 01/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

1 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00639834

Inglês

Eligibility Rheumatoid Arthritis NCT00639834

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have met acr criteria for the diagnosis of rheumatoid arthritis (ra)
Descrição

ACR Criteria Fulfill Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0003873
must have active ra
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
must be treated with methotrexate (mtx) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
Descrição

Methotrexate U/week Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0560588
UMLS CUI [1,3]
C0205360
all other dmards or biologics must be discontinued at least 28 days prior to study drug administration and: 1) leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
Descrição

DMARDs To be stopped | Biological agents To be stopped | Leflunomide To be stopped | Infliximab To be stopped | Adalimumab To be stopped | Abatacept To be stopped

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0063041
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C0666743
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C1122087
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C1619966
UMLS CUI [6,2]
C1272691
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
both rheumatoid factor and anti-ccp negative
Descrição

Rheumatoid factor negative | Anti-CCP Negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0427391
UMLS CUI [2,1]
C4318437
UMLS CUI [2,2]
C1513916
prior treatment with any b-cell depleting therapy
Descrição

B-cell depletion therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1171324
any other mab or ig-based fusion proteins 56 days or less prior to visit
Descrição

Fusion protein Immunoglobulin Based

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162768
UMLS CUI [1,2]
C0021027
UMLS CUI [1,3]
C1705938
history of or current inflammatory joint disease other than ra
Descrição

Inflammatory joint disease | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
neuropathies or neurovasculopathies that might interfere with pain evaluation
Descrição

Neuropathy Interferes with Evaluation Pain | Neurovascular Disorder Interferes with Evaluation Pain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0030193
UMLS CUI [2,1]
C3898144
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0030193
complications of ra or other disease
Descrição

Complications Rheumatoid Arthritis | Disease complications

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C0544688
any other autoimmune disease other than ra
Descrição

Autoimmune Disease | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
acute or chronic infection
Descrição

Communicable Disease | Chronic infectious disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
clinically significant disease requiring
Descrição

Disease Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
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Similar models

Eligibility Rheumatoid Arthritis NCT00639834

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ACR Criteria Fulfill Rheumatoid Arthritis
Item
must have met acr criteria for the diagnosis of rheumatoid arthritis (ra)
boolean
C3273747 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Rheumatoid Arthritis
Item
must have active ra
boolean
C0003873 (UMLS CUI [1])
Methotrexate U/week Stable
Item
must be treated with methotrexate (mtx) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
boolean
C0025677 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
DMARDs To be stopped | Biological agents To be stopped | Leflunomide To be stopped | Infliximab To be stopped | Adalimumab To be stopped | Abatacept To be stopped
Item
all other dmards or biologics must be discontinued at least 28 days prior to study drug administration and: 1) leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
boolean
C0242708 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0063041 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0666743 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C1122087 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C1619966 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Rheumatoid factor negative | Anti-CCP Negative
Item
both rheumatoid factor and anti-ccp negative
boolean
C0427391 (UMLS CUI [1])
C4318437 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
B-cell depletion therapy
Item
prior treatment with any b-cell depleting therapy
boolean
C1171324 (UMLS CUI [1])
Fusion protein Immunoglobulin Based
Item
any other mab or ig-based fusion proteins 56 days or less prior to visit
boolean
C0162768 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of or current inflammatory joint disease other than ra
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Neuropathy Interferes with Evaluation Pain | Neurovascular Disorder Interferes with Evaluation Pain
Item
neuropathies or neurovasculopathies that might interfere with pain evaluation
boolean
C0442874 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C3898144 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
Complications Rheumatoid Arthritis | Disease complications
Item
complications of ra or other disease
boolean
C0009566 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0544688 (UMLS CUI [2])
Autoimmune Disease | Exception Rheumatoid Arthritis
Item
any other autoimmune disease other than ra
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Communicable Disease | Chronic infectious disease
Item
acute or chronic infection
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Disease Clinical Significance
Item
clinically significant disease requiring
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
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