ID

34510

Descrição

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00754572

Link

https://clinicaltrials.gov/show/NCT00754572

Palavras-chave

  1. 18/01/2019 18/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00754572

Eligibility Rheumatoid Arthritis NCT00754572

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients >=18 years with moderate to severe active ra for at least 6 months;
Descrição

Age | Moderate rheumatoid arthritis Disease length | Rheumatoid Arthritis Severe Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C2368567
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0003873
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0872146
swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
Descrição

Swollen joint count | Tender joint count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
inadequate response to stable dose of mtx;
Descrição

Methotrexate Dose Stable | Poor response to treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C1320680
patients of reproductive potential must be using a reliable means of contraception.
Descrição

Females & males of reproductive potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra;
Descrição

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
patients with functional class iv ra;
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
diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than ra;
Descrição

Juvenile rheumatoid arthritis | Rheumatoid Arthritis Relationship Age | Inflammatory joint disease Except Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3714757
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0001779
UMLS CUI [3,1]
C0683381
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0003873
prior treatment failure with anti-tumor necrosis factor agent;
Descrição

Anti-tumor necrosis factor therapy failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0281481
UMLS CUI [1,2]
C0231175
pregnant or breastfeeding women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Rheumatoid Arthritis NCT00754572

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Moderate rheumatoid arthritis Disease length | Rheumatoid Arthritis Severe Disease length
Item
patients >=18 years with moderate to severe active ra for at least 6 months;
boolean
C0001779 (UMLS CUI [1])
C2368567 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0003873 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0872146 (UMLS CUI [3,3])
Swollen joint count | Tender joint count
Item
swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Methotrexate Dose Stable | Poor response to treatment
Item
inadequate response to stable dose of mtx;
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1320680 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods
Item
patients of reproductive potential must be using a reliable means of contraception.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than ra;
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Rheumatoid Arthritis Functional Status Class
Item
patients with functional class iv ra;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Juvenile rheumatoid arthritis | Rheumatoid Arthritis Relationship Age | Inflammatory joint disease Except Rheumatoid Arthritis
Item
diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than ra;
boolean
C3714757 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0001779 (UMLS CUI [2,3])
C0683381 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0003873 (UMLS CUI [3,3])
Anti-tumor necrosis factor therapy failed
Item
prior treatment failure with anti-tumor necrosis factor agent;
boolean
C0281481 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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