ID

34524

Descripción

An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE); ODM derived from: https://clinicaltrials.gov/show/NCT01384461

Link

https://clinicaltrials.gov/show/NCT01384461

Palabras clave

Versiones (1)
  1. 18/1/19 18/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01384461

Inglés

Eligibility Rheumatoid Arthritis NCT01384461

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe rheumatoid arthritis
Descripción

Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
roactemra/actemra treatment initiated by rheumatologist in an arthritis center for (up to 2 months prior to study entry)
Descripción

RoActemra | Actemra

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3272237
UMLS CUI [2]
C2740854
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
Descripción

Allergic Reaction Severe Investigational New Drug Component | Anaphylaxis Severe Investigational New Drug Component | Hypersensitivity Investigational New Drug Component

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C1705248
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1705248
active, severe infection or history of recurrent clinically significant infection
Descripción

Communicable Disease Severe | Recurrent infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0239998
pregnancy
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
Descripción

Investigational New Drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
methotrexate intolerance
Descripción

Intolerance to Methotrexate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0025677
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Similar models

Eligibility Rheumatoid Arthritis NCT01384461

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 disease activity, moderate | Rheumatoid Arthritis Severe
Item
moderate to severe rheumatoid arthritis
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
RoActemra | Actemra
Item
roactemra/actemra treatment initiated by rheumatologist in an arthritis center for (up to 2 months prior to study entry)
boolean
C3272237 (UMLS CUI [1])
C2740854 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Severe Investigational New Drug Component | Anaphylaxis Severe Investigational New Drug Component | Hypersensitivity Investigational New Drug Component
Item
history of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Communicable Disease Severe | Recurrent infection
Item
active, severe infection or history of recurrent clinically significant infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0239998 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Investigational New Drug
Item
treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
boolean
C0013230 (UMLS CUI [1])
Intolerance to Methotrexate
Item
methotrexate intolerance
boolean
C1744706 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
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