ID

37147

Descripción

Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan; ODM derived from: https://clinicaltrials.gov/show/NCT02335606

Link

https://clinicaltrials.gov/show/NCT02335606

Palabras clave

Versiones (1)
  1. 4/7/19 4/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02335606

Inglés

Eligibility Rheumatoid Arthritis NCT02335606

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥ 20 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
who give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
confirmed diagnosis of ra (as defined by american college of rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
who self-pay or who are reimbursed by bnhi for abatacept treatment
Descripción

Self-pay | Reimbursement National Health Insurance | abatacept

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3530213
UMLS CUI [2,1]
C0021684
UMLS CUI [2,2]
C0027452
UMLS CUI [3]
C1619966
with latent tb or who are receiving anti-tb treatment (inh 300 mg, qd) 1 month prior to using abatacept and continuously up to a total of 9 months willing to follow taiwan risk management plan guidelines as required by taiwan health authorities
Descripción

Latent Tuberculosis | Antitubercular Agents U/day | Adherence Risk Management Plan

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1609538
UMLS CUI [2,1]
C0003448
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2699091
are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
Descripción

Abatacept | Abatacept Absent | Abatacept Initiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1619966
UMLS CUI [2,1]
C1619966
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1619966
UMLS CUI [3,2]
C1704686
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
with active tb
Descripción

Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041296
hbsag (+)and/or anti-hcv(+) and/or hbv dna(+)
Descripción

Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | Hepatitis B DNA assay positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C1168040
have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
Descripción

Malignant Neoplasms | Exception Malignant Neoplasm Treated | Exception Neoplasm Free of Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
are allergic to abatacept
Descripción

Hypersensitivity Abatacept

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1619966
enrolled in other ra clinical studies
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Rheumatoid Arthritis NCT02335606

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
≥ 20 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
who give informed consent
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis
Item
confirmed diagnosis of ra (as defined by american college of rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
boolean
C0003873 (UMLS CUI [1])
Self-pay | Reimbursement National Health Insurance | abatacept
Item
who self-pay or who are reimbursed by bnhi for abatacept treatment
boolean
C3530213 (UMLS CUI [1])
C0021684 (UMLS CUI [2,1])
C0027452 (UMLS CUI [2,2])
C1619966 (UMLS CUI [3])
Latent Tuberculosis | Antitubercular Agents U/day | Adherence Risk Management Plan
Item
with latent tb or who are receiving anti-tb treatment (inh 300 mg, qd) 1 month prior to using abatacept and continuously up to a total of 9 months willing to follow taiwan risk management plan guidelines as required by taiwan health authorities
boolean
C1609538 (UMLS CUI [1])
C0003448 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1510802 (UMLS CUI [3,1])
C2699091 (UMLS CUI [3,2])
Abatacept | Abatacept Absent | Abatacept Initiation
Item
are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
boolean
C1619966 (UMLS CUI [1])
C1619966 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1619966 (UMLS CUI [3,1])
C1704686 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tuberculosis
Item
with active tb
boolean
C0041296 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | Hepatitis B DNA assay positive
Item
hbsag (+)and/or anti-hcv(+) and/or hbv dna(+)
boolean
C0149709 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1168040 (UMLS CUI [3])
Malignant Neoplasms | Exception Malignant Neoplasm Treated | Exception Neoplasm Free of Duration
Item
have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Hypersensitivity Abatacept
Item
are allergic to abatacept
boolean
C0020517 (UMLS CUI [1,1])
C1619966 (UMLS CUI [1,2])
Study Subject Participation Status
Item
enrolled in other ra clinical studies
boolean
C2348568 (UMLS CUI [1])
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