ID

31950

Descripción

Applications for Methotrexate Optimization in Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01038349

Link

https://clinicaltrials.gov/show/NCT01038349

Palabras clave

Versiones (1)
  1. 9/10/18 9/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01038349

Inglés

Eligibility Rheumatoid Arthritis NCT01038349

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to read, understand, and sign the informed consent form
Descripción

Able to read Informed Consent | Comprehension Informed Consent | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0021430
UMLS CUI [3]
C0021430
able to read, write, and speak english
Descripción

Able to read English Language | Able to write English Language | Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0564215
UMLS CUI [3,2]
C0376245
≥18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with ra within past 24 months (waiver)
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
taking oral methotrexate therapy for a minimum of 3 months
Descripción

Methotrexate Oral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3216566
considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing mtx dose or changing route of delivery, or adding or switching dmards (including but not limited to biologic dmards)
Descripción

Methotrexate | Response Insufficient | Therapy change Anticipated | Change Methotrexate Dosage | Change Drug Administration Route | DMARDs | Biologic DMARDs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231180
UMLS CUI [3,1]
C3665894
UMLS CUI [3,2]
C3840775
UMLS CUI [4,1]
C0392747
UMLS CUI [4,2]
C0025677
UMLS CUI [4,3]
C0178602
UMLS CUI [5,1]
C0392747
UMLS CUI [5,2]
C0013153
UMLS CUI [6]
C0242708
UMLS CUI [7]
C4055380
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure of the study center, study physician or study patient to the avise pg laboratory test
Descripción

Study Subject Participation Status | Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0022885
patients with known abnormal hepatic and or hematological parameters
Descripción

Parameters Hepatic Abnormal | Parameters Hematologic Abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205054
UMLS CUI [1,3]
C0205161
UMLS CUI [2,1]
C0449381
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C0205161
use of prednisone >10mg/day (or its equivalent)
Descripción

Prednisone U/day | Prednisone Equivalent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
rheumatologic diagnosis other than primary ra
Descripción

Rheumatic disease | Exception Rheumatoid Arthritis Primary

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [2,3]
C0205225
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Similar models

Eligibility Rheumatoid Arthritis NCT01038349

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Able to read Informed Consent | Comprehension Informed Consent | Informed Consent
Item
able to read, understand, and sign the informed consent form
boolean
C0586740 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Able to read English Language | Able to write English Language | Able to speak English Language
Item
able to read, write, and speak english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0564215 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Age
Item
≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
diagnosed with ra within past 24 months (waiver)
boolean
C0003873 (UMLS CUI [1])
Methotrexate Oral
Item
taking oral methotrexate therapy for a minimum of 3 months
boolean
C3216566 (UMLS CUI [1])
Methotrexate | Response Insufficient | Therapy change Anticipated | Change Methotrexate Dosage | Change Drug Administration Route | DMARDs | Biologic DMARDs
Item
considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing mtx dose or changing route of delivery, or adding or switching dmards (including but not limited to biologic dmards)
boolean
C0025677 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
C3665894 (UMLS CUI [3,1])
C3840775 (UMLS CUI [3,2])
C0392747 (UMLS CUI [4,1])
C0025677 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0392747 (UMLS CUI [5,1])
C0013153 (UMLS CUI [5,2])
C0242708 (UMLS CUI [6])
C4055380 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Laboratory Procedures
Item
prior exposure of the study center, study physician or study patient to the avise pg laboratory test
boolean
C2348568 (UMLS CUI [1])
C0022885 (UMLS CUI [2])
Parameters Hepatic Abnormal | Parameters Hematologic Abnormal
Item
patients with known abnormal hepatic and or hematological parameters
boolean
C0449381 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0449381 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
Prednisone U/day | Prednisone Equivalent
Item
use of prednisone >10mg/day (or its equivalent)
boolean
C0032952 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Rheumatic disease | Exception Rheumatoid Arthritis Primary
Item
rheumatologic diagnosis other than primary ra
boolean
C0035435 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
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