ID

31880

Description

A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs); ODM derived from: https://clinicaltrials.gov/show/NCT00891020

Link

https://clinicaltrials.gov/show/NCT00891020

Keywords

Versions (1)
  1. 10/6/18 10/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 6, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT00891020

English

Eligibility Rheumatoid Arthritis NCT00891020

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >=18 years of age;
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe active rheumatoid arthritis for >6 months;
Description

Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Data type

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy;
Description

DMARD Response Inadequate | Intolerance to DMARD

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0242708
swollen joint count (sjc) >/=4 and tender joint count (tjc) >/=4
Description

Swollen joint count | Tender joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
body weight </=150kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
current permitted non-biologic dmards must be on stable dose for >/= 7 weeks prior to baseline;
Description

DMARDs Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
Description

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0683381
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003873
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis;
Description

Rheumatoid Arthritis Functional Status Class

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
treatment with rituximab within 6 months before screening;
Description

rituximab

Data type

boolean

Alias
UMLS CUI [1]
C0393022
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
Description

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Description

Communicable Disease | Recurrent infections | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0239998
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0009450
UMLS CUI [4]
C1708385
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0003232
UMLS CUI [5,3]
C1522726
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003232
UMLS CUI [6,3]
C1527415
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT00891020

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >=18 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
moderate to severe active rheumatoid arthritis for >6 months;
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
DMARD Response Inadequate | Intolerance to DMARD
Item
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy;
boolean
C0242708 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0242708 (UMLS CUI [2,2])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) >/=4 and tender joint count (tjc) >/=4
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Body Weight
Item
body weight </=150kg
boolean
C0005910 (UMLS CUI [1])
DMARDs Dose Stable
Item
current permitted non-biologic dmards must be on stable dose for >/= 7 weeks prior to baseline;
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
boolean
C0004364 (UMLS CUI [1])
C0683381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
rituximab
Item
treatment with rituximab within 6 months before screening;
boolean
C0393022 (UMLS CUI [1])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Communicable Disease | Recurrent infections | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral
Item
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0003232 (UMLS CUI [5,2])
C1522726 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0003232 (UMLS CUI [6,2])
C1527415 (UMLS CUI [6,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial