ID

31877

Descripción

Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00850343

Link

https://clinicaltrials.gov/show/NCT00850343

Palabras clave

Versiones (1)
  1. 6/10/18 6/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Rheumatoid Arthritis NCT00850343

Inglés

Eligibility Rheumatoid Arthritis NCT00850343

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who participated in study 275-08-003 and meet all of the criteria described below.
Descripción

Study Subject Participation Status | Clinical Trial Specified | Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C1550543
patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24.
Descripción

ACR Criteria failed | Clinical Trial Specified Premature Discontinued | Clinical Trial Specified Completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C4018905
UMLS CUI [2,4]
C1444662
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205369
UMLS CUI [3,3]
C0205197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who experienced an important protocol deviation as mentioned below during study 275-08-003.
Descripción

Protocol Deviation Important

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C3898777
patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines).
Descripción

Live Vaccine | Exception Influenza | Exception Pneumococcal vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021400
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0358314
patients who were found to have tuberculosis on a chest x-ray during study 275-08-003.
Descripción

Tuberculosis Chest X-ray

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0039985
patients who required treatment for the same infection at two or more different times during study 275-08-003
Descripción

Communicable Disease Same | Treatment required for Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0445247
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C1265611
women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032992
patients whom the investigator has decided to be inappropriate for participation in the study
Descripción

Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
Volver a la parte superior de la página

Similar models

Eligibility Rheumatoid Arthritis NCT00850343

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Specified | Criteria Fulfill
Item
subjects who participated in study 275-08-003 and meet all of the criteria described below.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
ACR Criteria failed | Clinical Trial Specified Premature Discontinued | Clinical Trial Specified Completed
Item
patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24.
boolean
C3273747 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Protocol Deviation Important
Item
patients who experienced an important protocol deviation as mentioned below during study 275-08-003.
boolean
C1705236 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
Live Vaccine | Exception Influenza | Exception Pneumococcal vaccine
Item
patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines).
boolean
C0042211 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021400 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0358314 (UMLS CUI [3,2])
Tuberculosis Chest X-ray
Item
patients who were found to have tuberculosis on a chest x-ray during study 275-08-003.
boolean
C0041296 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Communicable Disease Same | Treatment required for Quantity
Item
patients who required treatment for the same infection at two or more different times during study 275-08-003
boolean
C0009450 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate
Item
patients whom the investigator has decided to be inappropriate for participation in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial