ID

31880

Descrição

A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs); ODM derived from: https://clinicaltrials.gov/show/NCT00891020

Link

https://clinicaltrials.gov/show/NCT00891020

Palavras-chave

Versões (1)
  1. 06/10/2018 06/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00891020

Inglês

Eligibility Rheumatoid Arthritis NCT00891020

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >=18 years of age;
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe active rheumatoid arthritis for >6 months;
Descrição

Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy;
Descrição

DMARD Response Inadequate | Intolerance to DMARD

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0242708
swollen joint count (sjc) >/=4 and tender joint count (tjc) >/=4
Descrição

Swollen joint count | Tender joint count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
body weight </=150kg
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
current permitted non-biologic dmards must be on stable dose for >/= 7 weeks prior to baseline;
Descrição

DMARDs Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
Descrição

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0683381
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003873
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis;
Descrição

Rheumatoid Arthritis Functional Status Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
treatment with rituximab within 6 months before screening;
Descrição

rituximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0393022
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
Descrição

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Descrição

Communicable Disease | Recurrent infections | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0239998
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0009450
UMLS CUI [4]
C1708385
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0003232
UMLS CUI [5,3]
C1522726
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003232
UMLS CUI [6,3]
C1527415
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Similar models

Eligibility Rheumatoid Arthritis NCT00891020

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >=18 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
moderate to severe active rheumatoid arthritis for >6 months;
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
DMARD Response Inadequate | Intolerance to DMARD
Item
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy;
boolean
C0242708 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0242708 (UMLS CUI [2,2])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) >/=4 and tender joint count (tjc) >/=4
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Body Weight
Item
body weight </=150kg
boolean
C0005910 (UMLS CUI [1])
DMARDs Dose Stable
Item
current permitted non-biologic dmards must be on stable dose for >/= 7 weeks prior to baseline;
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
boolean
C0004364 (UMLS CUI [1])
C0683381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
rituximab
Item
treatment with rituximab within 6 months before screening;
boolean
C0393022 (UMLS CUI [1])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Communicable Disease | Recurrent infections | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral
Item
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0003232 (UMLS CUI [5,2])
C1522726 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0003232 (UMLS CUI [6,2])
C1527415 (UMLS CUI [6,3])
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