ID

31859

Descripción

A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood; ODM derived from: https://clinicaltrials.gov/show/NCT00781469

Link

https://clinicaltrials.gov/show/NCT00781469

Palabras clave

Versiones (1)
  1. 4/10/18 4/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 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 NCT00781469

Inglés

Eligibility Rheumatoid Arthritis NCT00781469

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult men and non-pregnant, non-lactating women between 18 and 75 years of age. sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
Descripción

Adult | Gender | Age | Pregnancy Absent | Breast Feeding Absent | Gender Sexually active Childbearing Potential Absent | Childbearing Potential Sexually active Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0006147
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C3831118
UMLS CUI [6,4]
C0332197
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0241028
UMLS CUI [7,3]
C0700589
body weight greater >40 kg and <120 kg with a body mass index (bmi) between 19-31 kg/m2
Descripción

Body Weight | Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
clinical history of rheumatoid arthritis as defined by acr criteria
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
Descripción

Childbearing Potential Urine pregnancy test negative | Exception Hysterectomy | Exception Bilateral oophorectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020699
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0278321
for populations b and c only
Descripción

Population Roman letter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0439102
currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only dmard (no changes in dosing regimen for 4 weeks prior to screening).
Descripción

Methotrexate Dose Stable U/week | Antirheumatic Drugs, Disease-Modifying

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2]
C0242708
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an acute illness within 2 weeks prior to the study
Descripción

Acute illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4061114
history of drug abuse within 2 years
Descripción

Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
donation of blood in excess of 500 ml within 56 days prior to the first dose of study medication
Descripción

Blood Donation Excess

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
for group a only
Descripción

Group Roman letter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0439102
prior treatment with disease modifying anti-rheumatic agents or biologicals.
Descripción

Prior Therapy | Antirheumatic Drugs, Disease-Modifying | Biological agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0005515
Volver a la parte superior de la página

Similar models

Eligibility Rheumatoid Arthritis NCT00781469

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age | Pregnancy Absent | Breast Feeding Absent | Gender Sexually active Childbearing Potential Absent | Childbearing Potential Sexually active Contraceptive methods
Item
adult men and non-pregnant, non-lactating women between 18 and 75 years of age. sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C3831118 (UMLS CUI [6,3])
C0332197 (UMLS CUI [6,4])
C3831118 (UMLS CUI [7,1])
C0241028 (UMLS CUI [7,2])
C0700589 (UMLS CUI [7,3])
Body Weight | Body mass index
Item
body weight greater >40 kg and <120 kg with a body mass index (bmi) between 19-31 kg/m2
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Rheumatoid Arthritis
Item
clinical history of rheumatoid arthritis as defined by acr criteria
boolean
C0003873 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Exception Hysterectomy | Exception Bilateral oophorectomy
Item
negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020699 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0278321 (UMLS CUI [3,2])
Population Roman letter
Item
for populations b and c only
boolean
C1257890 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Methotrexate Dose Stable U/week | Antirheumatic Drugs, Disease-Modifying
Item
currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only dmard (no changes in dosing regimen for 4 weeks prior to screening).
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute illness
Item
history of an acute illness within 2 weeks prior to the study
boolean
C4061114 (UMLS CUI [1])
Drug abuse
Item
history of drug abuse within 2 years
boolean
C0013146 (UMLS CUI [1])
Blood Donation Excess
Item
donation of blood in excess of 500 ml within 56 days prior to the first dose of study medication
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
Group Roman letter
Item
for group a only
boolean
C1257890 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Prior Therapy | Antirheumatic Drugs, Disease-Modifying | Biological agents
Item
prior treatment with disease modifying anti-rheumatic agents or biologicals.
boolean
C1514463 (UMLS CUI [1])
C0242708 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
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