ID

23029

Description

The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.; ODM derived from: https://clinicaltrials.gov/show/NCT01270087

Link

https://clinicaltrials.gov/show/NCT01270087

Keywords

  1. 6/20/17 6/20/17 -
Uploaded on

June 20, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01270087

Eligibility Rheumatoid Arthritis NCT01270087

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of rheumatoid arthritis
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
fulfillment of the american college of rheumatology 1987 criteria for rheumatoid arthritis
Description

Rheumatoid Arthritis Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
active disease despite treatment with at least one disease modifying anti-rheumatic drug
Description

Disease-Modifying Antirheumatic Drugs Quantity | Persistent Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C2983415
treatment with adalimumab indicated according to the the patient's rheumatologist
Description

Indication adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1122087
at least six swollen joints in 28-joint index
Description

Swollen joint Quantity Disease activity score using 28 joint count

Data type

boolean

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2711347
crp > 8 mg / l within the last three months
Description

C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201657
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with anti-tnf drugs in the last three months
Description

Anti-tumor necrosis factor alpha drug

Data type

boolean

Alias
UMLS CUI [1]
C1562242
treatment with intravenous corticosteroids within fourteen days
Description

Adrenal Cortex Hormones Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522726
ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
Description

Adrenal Cortex Hormones Oral High dose | Prednisolone U/day equivalent | Adrenal Cortex Hormones Oral High dose Treatment completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0444956
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C3242703
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0444956
UMLS CUI [3,4]
C0580352
severe bleeding disorder
Description

Blood Coagulation Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205082
extensive or refractory leg ulcers
Description

Leg Ulcer Extensive | Leg Ulcer refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C0023223
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0023223
UMLS CUI [2,2]
C0205269
severe peripheral vascular disease
Description

Peripheral Vascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082

Similar models

Eligibility Rheumatoid Arthritis NCT01270087

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
clinical diagnosis of rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis Criteria Fulfill
Item
fulfillment of the american college of rheumatology 1987 criteria for rheumatoid arthritis
boolean
C0003873 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Disease-Modifying Antirheumatic Drugs Quantity | Persistent Disease
Item
active disease despite treatment with at least one disease modifying anti-rheumatic drug
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2983415 (UMLS CUI [2])
Indication adalimumab
Item
treatment with adalimumab indicated according to the the patient's rheumatologist
boolean
C3146298 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
Swollen joint Quantity Disease activity score using 28 joint count
Item
at least six swollen joints in 28-joint index
boolean
C0152031 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2711347 (UMLS CUI [1,3])
C-reactive protein measurement
Item
crp > 8 mg / l within the last three months
boolean
C0201657 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Anti-tumor necrosis factor alpha drug
Item
treatment with anti-tnf drugs in the last three months
boolean
C1562242 (UMLS CUI [1])
Adrenal Cortex Hormones Intravenous
Item
treatment with intravenous corticosteroids within fourteen days
boolean
C0001617 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Adrenal Cortex Hormones Oral High dose | Prednisolone U/day equivalent | Adrenal Cortex Hormones Oral High dose Treatment completed
Item
ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C3242703 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0444956 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
Blood Coagulation Disorder Severe
Item
severe bleeding disorder
boolean
C0005779 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Leg Ulcer Extensive | Leg Ulcer refractory
Item
extensive or refractory leg ulcers
boolean
C0023223 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0023223 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Peripheral Vascular Disease Severe
Item
severe peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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