Information:
Fel:
ID
21726
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00254293
Nyckelord
Versioner (1)
- 2017-04-27 2017-04-27 -
Uppladdad den
27 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00254293
Eligibility Rheumatoid Arthritis NCT00254293
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00254293
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C0242708 (UMLS CUI [2])
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])
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])
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])
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])