ID

21726

Descripción

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT00254293

Link

https://clinicaltrials.gov/show/NCT00254293

Palabras clave

  1. 27/4/17 27/4/17 -
Subido en

27 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00254293

Eligibility Rheumatoid Arthritis NCT00254293

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet ara criteria for diagnosis of ra with active disease.
Descripción

Criteria for Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3273740
ra diagnosis for at least 1 year.
Descripción

Date of diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2316983
> = 6 swollen joints.
Descripción

Swollen joint count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451521
> = 8 tender joints.
Descripción

Tender joint count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451530
taking methotrexate (mtx) or mtx plus not more than 1 added oral dmard for > = 3 months and stable for 28 days prior to dosing.
Descripción

MTX and/ or DMARD treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0242708
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious acute or bacterial infection in last 3 months.
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
chronic or recurrent bacterial infections.
Descripción

Chronic or recurrent bacterial infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0239998
history of tb within previous 3 years or old tb not adequately treated.
Descripción

Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041296
specific lab test abnormalities
Descripción

Laboratory Test Result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2346633
history of cancer within 5 years.
Descripción

Prior Malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735088
exposure to ctla4ig (cytotoxic t-lymphocyte (t-cell)-associated antigen 4ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
Descripción

ctla4ig, belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1619966
UMLS CUI [2]
C1619962
UMLS CUI [3]
C0393022
UMLS CUI [4]
C1174995
UMLS CUI [5]
C0962603
UMLS CUI [6]
C0304229
treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, d-penicillamine or calcineurin inhibitors.
Descripción

Hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, d-penicillamine or calcineurin inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020336
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0063041
UMLS CUI [4]
C0179100
UMLS CUI [5]
C0209368
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0030817
UMLS CUI [8]
C1562036
exposure to live vaccines.
Descripción

Live vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042211

Similar models

Eligibility Rheumatoid Arthritis NCT00254293

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Criteria for Rheumatoid Arthritis
Item
meet ara criteria for diagnosis of ra with active disease.
boolean
C3273740 (UMLS CUI [1])
Date of diagnosis
Item
ra diagnosis for at least 1 year.
boolean
C2316983 (UMLS CUI [1])
Swollen joint count
Item
> = 6 swollen joints.
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
> = 8 tender joints.
boolean
C0451530 (UMLS CUI [1])
MTX and/ or DMARD treatment
Item
taking methotrexate (mtx) or mtx plus not more than 1 added oral dmard for > = 3 months and stable for 28 days prior to dosing.
boolean
C0025677 (UMLS CUI [1])
C0242708 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Infection
Item
serious acute or bacterial infection in last 3 months.
boolean
C0009450 (UMLS CUI [1])
Chronic or recurrent bacterial infections
Item
chronic or recurrent bacterial infections.
boolean
C0151317 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
Tuberculosis
Item
history of tb within previous 3 years or old tb not adequately treated.
boolean
C0041296 (UMLS CUI [1])
Laboratory Test Result
Item
specific lab test abnormalities
boolean
C2346633 (UMLS CUI [1])
Prior Malignancy
Item
history of cancer within 5 years.
boolean
C2735088 (UMLS CUI [1])
ctla4ig, belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic
Item
exposure to ctla4ig (cytotoxic t-lymphocyte (t-cell)-associated antigen 4ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
boolean
C1619966 (UMLS CUI [1])
C1619962 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C1174995 (UMLS CUI [4])
C0962603 (UMLS CUI [5])
C0304229 (UMLS CUI [6])
Hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, d-penicillamine or calcineurin inhibitors
Item
treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, d-penicillamine or calcineurin inhibitors.
boolean
C0020336 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0063041 (UMLS CUI [3])
C0179100 (UMLS CUI [4])
C0209368 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0030817 (UMLS CUI [7])
C1562036 (UMLS CUI [8])
Live vaccine
Item
exposure to live vaccines.
boolean
C0042211 (UMLS CUI [1])

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