Information:
Error:
ID
13096
Description
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00195663
Link
https://clinicaltrials.gov/show/NCT00195663
Keywords
Versions (1)
- 1/15/16 1/15/16 -
Uploaded on
January 15, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Early Rheumatoid Arthritis NCT00195663
Eligibility Early Rheumatoid Arthritis NCT00195663
- StudyEvent: Eligibility
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Eligibility Early Rheumatoid Arthritis NCT00195663
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
age, health status, history
Item
subject was age 18 or older and in good health (investigator discretion) with a recent stable medical history.
boolean
C0001779 (UMLS CUI [1])
C0018759 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0018759 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
rheumatoid arthritis
Item
diagnosis of rheumatoid arthritis (ra) as defined by the 1987-revised american college of rheumatology (acr) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (rf) positivity, erythrocyte sedimentation rate (esr) >= 28 mm/1h or c-reactive protein (crp) >= 1.5 mg/dl
boolean
C0003873 (UMLS CUI [1])
diagnosis age
Item
chronic arthritis diagnosed before the age of 16
boolean
C0011900 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
dmard
Item
preceding treatment with mtx, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (dmards)
boolean
C0242708 (UMLS CUI [1])
anti-tumor necrosis factor
Item
subject previously received anti-tumor necrosis factor (tnf) therapy
boolean
C0281481 (UMLS CUI [1])
wheelchair bedridden
Item
permanently wheelchair-bound or bedridden patients
boolean
C0043143 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
C0741453 (UMLS CUI [2])
unsuitable
Item
subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
boolean
C3844399 (UMLS CUI [1])
pregnancy, breastfeeding
Item
female subject who is pregnant or breast-feeding or considering becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])