ID

16895

Description

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00579878

Link

https://clinicaltrials.gov/show/NCT00579878

Keywords

  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00579878

Eligibility Rheumatoid Arthritis NCT00579878

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater or 19 years and less than or 80 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
duration of disease greater or equal to 6 months
Description

Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
diagnosis of ra with criteria
Description

Rheumatoid arthritis: Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0242801
negative urine pregnancy test
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
be capable of understanding and giving written, voluntary informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must present with at least six swollen and six tender joints at the screening evaluation
Description

Number of tender joints

Data type

boolean

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C0449788
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients treated previously with leflunomide
Description

Leflunomide

Data type

boolean

Alias
UMLS CUI [1]
C0063041
patients that have been treated with methotrexate in combination with any of the study drugs
Description

Methotrexate in combination with study drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0304229
patients with a history of allergy to, or any history of significant clinical or laboratory adverse experience associated with any of the study drugs
Description

Hypersensitivity: Study Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
doses of oral steroids that are either unstable or greater than 10mg/day
Description

Steroids: Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0178602
stage iv disease or other significant disease including chest x-rays that show evidence of rheumatoid lung disease. stage iv disease is defined as x-ray evidence of cartilage/bone destruction with fibrous or bony ankylosis; creatinine greater than 2.0mg/dl, ast or alt greater normal
Description

Grade of disease and rheumatoid lung disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C2889132
any significant liver, renal , hematologic, pulmonary, cardiovascular disease (including uncontrolled hypertension), any active peptic ulcer disease, or visual problems including a recent decrease in acuity, retinal disease, or macular degeneration
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients who are not willing to abstain from alcohol consumption
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
patients that are unable to understand the study procedures and/or give written informed consent.
Description

Cognitive Function and Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0392335
UMLS CUI [2]
C0021430

Similar models

Eligibility Rheumatoid Arthritis NCT00579878

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater or 19 years and less than or 80 years old
boolean
C0001779 (UMLS CUI [1])
Disease length
Item
duration of disease greater or equal to 6 months
boolean
C0872146 (UMLS CUI [1])
Rheumatoid arthritis: Criteria
Item
diagnosis of ra with criteria
boolean
C0003873 (UMLS CUI [1,1])
C0242801 (UMLS CUI [1,2])
Pregnancy Test
Item
negative urine pregnancy test
boolean
C0032976 (UMLS CUI [1])
Informed Consent
Item
be capable of understanding and giving written, voluntary informed consent
boolean
C0021430 (UMLS CUI [1])
Number of tender joints
Item
must present with at least six swollen and six tender joints at the screening evaluation
boolean
C0240094 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Leflunomide
Item
patients treated previously with leflunomide
boolean
C0063041 (UMLS CUI [1])
Methotrexate in combination with study drugs
Item
patients that have been treated with methotrexate in combination with any of the study drugs
boolean
C0025677 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Hypersensitivity: Study Drug
Item
patients with a history of allergy to, or any history of significant clinical or laboratory adverse experience associated with any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Steroids: Dosage
Item
doses of oral steroids that are either unstable or greater than 10mg/day
boolean
C0038317 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Grade of disease and rheumatoid lung disease
Item
stage iv disease or other significant disease including chest x-rays that show evidence of rheumatoid lung disease. stage iv disease is defined as x-ray evidence of cartilage/bone destruction with fibrous or bony ankylosis; creatinine greater than 2.0mg/dl, ast or alt greater normal
boolean
C0441800 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C2889132 (UMLS CUI [2])
Comorbidity
Item
any significant liver, renal , hematologic, pulmonary, cardiovascular disease (including uncontrolled hypertension), any active peptic ulcer disease, or visual problems including a recent decrease in acuity, retinal disease, or macular degeneration
boolean
C0009488 (UMLS CUI [1])
Alcohol consumption
Item
patients who are not willing to abstain from alcohol consumption
boolean
C0001948 (UMLS CUI [1])
Gynaecological status
Item
women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Cognitive Function and Informed Consent
Item
patients that are unable to understand the study procedures and/or give written informed consent.
boolean
C0392335 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

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