ID

31986

Descripción

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT01224418

Link

https://clinicaltrials.gov/show/NCT01224418

Palabras clave

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

See clinicaltrials.gov

Subido en

10 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 NCT01224418

Inglés

Eligibility Rheumatoid Arthritis NCT01224418

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with more than 6 months history of rheumatoid arthritis according to acr criteria
Descripción

Rheumatoid Arthritis Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
patients who have been treated unsuccessfully to more than single dmards including methotrexate at the discretion of investigator
Descripción

DMARDs Quantity Treatment unsuccessful | Methotrexate Treatment unsuccessful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0438286
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0438286
esr ≥ 30 mm/h or crp ≥ 1.0 mg/dl (esr: erythrocyte sedimentation rate, crp: c-reactive protein)
Descripción

Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176468
UMLS CUI [2]
C0201657
patients are required to have at least 3 of 66 joints assessed as swollen
Descripción

Swollen joint count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451521
patients are required to have at least 6 of 68 joints assessed as painful with pressure
Descripción

Painful joints With Pressure Count

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1306345
UMLS CUI [1,4]
C0750480
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Breast Feeding Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C1301732
previous experience of tacrolimus (ointment excluded)
Descripción

Tacrolimus | Ointment Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085149
UMLS CUI [2,1]
C0028912
UMLS CUI [2,2]
C0332196
renal impairment or serum creatinine > 1.4 mg/dl
Descripción

Renal Insufficiency | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, sgot/sgpt > 2x upper limit normal
Descripción

Liver Failure | Viral hepatitis | Non-viral hepatitis | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0042721
UMLS CUI [3]
C4268643
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0151904
UMLS CUI [6]
C0151905
patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:blood glucose level >110mg/dl before the meal and >200mg/dl after the meal hba1c > 6.4%
Descripción

Pancreatitis | Impaired glucose tolerance | Glucose Complication | Blood glucose measurement ante cibus | Blood glucose measurement Postprandial | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0271650
UMLS CUI [3,1]
C0017725
UMLS CUI [3,2]
C0009566
UMLS CUI [4,1]
C0392201
UMLS CUI [4,2]
C1550738
UMLS CUI [5,1]
C0392201
UMLS CUI [5,2]
C0376674
UMLS CUI [6]
C0474680
cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
Descripción

Heart Disease | Myocardial Ischemia | Cardiac Arrhythmia Treatment required for | Heart failure | Cardiac complication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0151744
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0161816
other investigational drug within last 30 days
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
Descripción

infliximab | adalimumab | leflunomide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C1122087
UMLS CUI [3]
C0063041
Volver a la parte superior de la página

Similar models

Eligibility Rheumatoid Arthritis NCT01224418

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Disease length
Item
patients with more than 6 months history of rheumatoid arthritis according to acr criteria
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
DMARDs Quantity Treatment unsuccessful | Methotrexate Treatment unsuccessful
Item
patients who have been treated unsuccessfully to more than single dmards including methotrexate at the discretion of investigator
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0438286 (UMLS CUI [2,2])
Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
esr ≥ 30 mm/h or crp ≥ 1.0 mg/dl (esr: erythrocyte sedimentation rate, crp: c-reactive protein)
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
Swollen joint count
Item
patients are required to have at least 3 of 66 joints assessed as swollen
boolean
C0451521 (UMLS CUI [1])
Painful joints With Pressure Count
Item
patients are required to have at least 6 of 68 joints assessed as painful with pressure
boolean
C0003862 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1306345 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Breast Feeding Planned
Item
pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Tacrolimus | Ointment Excluded
Item
previous experience of tacrolimus (ointment excluded)
boolean
C0085149 (UMLS CUI [1])
C0028912 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment or serum creatinine > 1.4 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver Failure | Viral hepatitis | Non-viral hepatitis | Liver Cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, sgot/sgpt > 2x upper limit normal
boolean
C0085605 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C4268643 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0151904 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
Pancreatitis | Impaired glucose tolerance | Glucose Complication | Blood glucose measurement ante cibus | Blood glucose measurement Postprandial | Hemoglobin A1c measurement
Item
patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:blood glucose level >110mg/dl before the meal and >200mg/dl after the meal hba1c > 6.4%
boolean
C0030305 (UMLS CUI [1])
C0271650 (UMLS CUI [2])
C0017725 (UMLS CUI [3,1])
C0009566 (UMLS CUI [3,2])
C0392201 (UMLS CUI [4,1])
C1550738 (UMLS CUI [4,2])
C0392201 (UMLS CUI [5,1])
C0376674 (UMLS CUI [5,2])
C0474680 (UMLS CUI [6])
Heart Disease | Myocardial Ischemia | Cardiac Arrhythmia Treatment required for | Heart failure | Cardiac complication
Item
cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
boolean
C0018799 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4])
C0161816 (UMLS CUI [5])
Investigational New Drugs
Item
other investigational drug within last 30 days
boolean
C0013230 (UMLS CUI [1])
infliximab | adalimumab | leflunomide
Item
patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
boolean
C0666743 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
C0063041 (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