ID

23008

Description

Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis (RA) Despite Methotrexate (MTX) Therapy in Japan; ODM derived from: https://clinicaltrials.gov/show/NCT00688103

Lien

https://clinicaltrials.gov/show/NCT00688103

Mots-clés

  1. 19/06/2017 19/06/2017 -
Téléchargé le

19 juin 2017

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00688103

Eligibility Rheumatoid Arthritis NCT00688103

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients had to be at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
fulfilled the 1987 revised classification criteria for ra by in american college of rheumatology (acr)
Description

Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
met the guidelines for the proper use of etn in japan (having at least 6 tender joints and 6 swollen joints
Description

Etanercept | Tender joint count | Swollen joint count

Type de données

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
either serum c-reactive protein more than 2 mg/dl or esr no less than 28 mm at 1 hour, with adequate safety profiles)
Description

serum C-reactive protein measurement | Erythrocyte sedimentation rate measurement

Type de données

boolean

Alias
UMLS CUI [1]
C2229674
UMLS CUI [2]
C1176468
be acr functional class i-iii
Description

Rheumatoid Arthritis Class Functional

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
have been receiving mtx 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
Description

Methotrexate U/week Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0560588
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who required concurrent use of prednisone (psl) >10 mg/day, or its equivalent, were excluded from study entry
Description

Prednisone U/day | prednisolone U/day | prednisolone equivalent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0032950
UMLS CUI [3,2]
C3242703
the start of dose increment of psl equivalents within 3 months of the study enrollment
Description

Prednisolone equivalent Dose Increment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032950
UMLS CUI [1,2]
C3242703
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1705117
experience of antirheumatic therapy except for mtx and psl equivalents
Description

Antirheumatic Agents | Methotrexate Excluded | Prednisolone equivalent Excluded

Type de données

boolean

Alias
UMLS CUI [1]
C0003191
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0032950
UMLS CUI [3,2]
C3242703
UMLS CUI [3,3]
C2828389
previous treatment with etn or any other biological treatment
Description

Etanercept | Biological treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C1531518

Similar models

Eligibility Rheumatoid Arthritis NCT00688103

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients had to be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
fulfilled the 1987 revised classification criteria for ra by in american college of rheumatology (acr)
boolean
C0003873 (UMLS CUI [1])
Etanercept | Tender joint count | Swollen joint count
Item
met the guidelines for the proper use of etn in japan (having at least 6 tender joints and 6 swollen joints
boolean
C0717758 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
serum C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
either serum c-reactive protein more than 2 mg/dl or esr no less than 28 mm at 1 hour, with adequate safety profiles)
boolean
C2229674 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Rheumatoid Arthritis Class Functional
Item
be acr functional class i-iii
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Methotrexate U/week Dose Stable
Item
have been receiving mtx 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
boolean
C0025677 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Prednisone U/day | prednisolone U/day | prednisolone equivalent
Item
patients who required concurrent use of prednisone (psl) >10 mg/day, or its equivalent, were excluded from study entry
boolean
C0032952 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
Prednisolone equivalent Dose Increment
Item
the start of dose increment of psl equivalents within 3 months of the study enrollment
boolean
C0032950 (UMLS CUI [1,1])
C3242703 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1705117 (UMLS CUI [1,4])
Antirheumatic Agents | Methotrexate Excluded | Prednisolone equivalent Excluded
Item
experience of antirheumatic therapy except for mtx and psl equivalents
boolean
C0003191 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Etanercept | Biological treatment
Item
previous treatment with etn or any other biological treatment
boolean
C0717758 (UMLS CUI [1])
C1531518 (UMLS CUI [2])

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