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

Lien

https://clinicaltrials.gov/show/NCT00195663

Mots-clés

  1. 15/01/2016 15/01/2016 -
Téléchargé le

15 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Early Rheumatoid Arthritis NCT00195663

Eligibility Early Rheumatoid Arthritis NCT00195663

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject was age 18 or older and in good health (investigator discretion) with a recent stable medical history.
Description

age, health status, history

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018759
UMLS CUI [3]
C0262926
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
Description

rheumatoid arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic arthritis diagnosed before the age of 16
Description

diagnosis age

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0001779
preceding treatment with mtx, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (dmards)
Description

dmard

Type de données

boolean

Alias
UMLS CUI [1]
C0242708
subject previously received anti-tumor necrosis factor (tnf) therapy
Description

anti-tumor necrosis factor

Type de données

boolean

Alias
UMLS CUI [1]
C0281481
permanently wheelchair-bound or bedridden patients
Description

wheelchair bedridden

Type de données

boolean

Alias
UMLS CUI [1]
C0043143
UMLS CUI [2]
C0741453
subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Description

unsuitable

Type de données

boolean

Alias
UMLS CUI [1]
C3844399
female subject who is pregnant or breast-feeding or considering becoming pregnant
Description

pregnancy, breastfeeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Early Rheumatoid Arthritis NCT00195663

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
diagnosis age
Item
chronic arthritis diagnosed before the age of 16
boolean
C0011900 (UMLS CUI [1,1])
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])
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])

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