ID

23797

Description

Remission Induction in Very Early Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00523692

Link

https://clinicaltrials.gov/show/NCT00523692

Keywords

Versions (1)
  1. 7/13/17 7/13/17 -
Uploaded on

July 13, 2017

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 NCT00523692

English

Eligibility Rheumatoid Arthritis NCT00523692

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age over 18 years
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0001779
synovial swelling of at least 1 joint confirmed by clinical assessment
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0221608
duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0436359
UMLS CUI [1,2]
C0683381
seropositivity for rf and anti-ccp ab
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C0035448
UMLS CUI [1,2]
C1138802
women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0009862
female subjects of childbearing potential must test negative for pregnancy
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous history of inflammatory arthritis.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0003864
previous use of dmards or anti-tnf-agents.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0281481
any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0021368
clinical evidence of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to study entry.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C1610637
administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0042211
a history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0410808
UMLS CUI [1,2]
C0003232
known infection with hiv, hepatitis b, or hepatitis c.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
a serious infection that in the opinion of the investigator precludes receipt of a tnf blocking agent.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C3714514
serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of tnf-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (nyha grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis).
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1]
C0012634
bleeding disorder of the use of anti-coagulants
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C0005779
any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence).
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any other contraindication to etanercept, methotrexate or parenteral depomedrone.
Description

ID.18

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0717758
patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than twice the upper limit of normal, and serum creatinine >150 micromoles/litre.
Description

ID.19

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0518015
UMLS CUI [1,3]
C0427547
UMLS CUI [1,4]
C0600061
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT00523692

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
synovial swelling of at least 1 joint confirmed by clinical assessment
boolean
C0221608 (UMLS CUI [1])
ID.3
Item
duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.
boolean
C0436359 (UMLS CUI [1,1])
C0683381 (UMLS CUI [1,2])
ID.4
Item
seropositivity for rf and anti-ccp ab
boolean
C0035448 (UMLS CUI [1,1])
C1138802 (UMLS CUI [1,2])
ID.5
Item
women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study.
boolean
C0009862 (UMLS CUI [1])
ID.6
Item
female subjects of childbearing potential must test negative for pregnancy
boolean
C0032961 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
previous history of inflammatory arthritis.
boolean
C0003864 (UMLS CUI [1])
ID.8
Item
previous use of dmards or anti-tnf-agents.
boolean
C0242708 (UMLS CUI [1,1])
C0281481 (UMLS CUI [1,2])
ID.9
Item
any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
boolean
C0021368 (UMLS CUI [1])
ID.10
Item
clinical evidence of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to study entry.
boolean
C1610637 (UMLS CUI [1])
ID.11
Item
administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial.
boolean
C0042211 (UMLS CUI [1])
ID.12
Item
a history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
boolean
C0410808 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
ID.13
Item
known infection with hiv, hepatitis b, or hepatitis c.
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
ID.14
Item
a serious infection that in the opinion of the investigator precludes receipt of a tnf blocking agent.
boolean
C3714514 (UMLS CUI [1])
ID.15
Item
serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of tnf-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (nyha grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis).
boolean
C0012634 (UMLS CUI [1])
ID.16
Item
bleeding disorder of the use of anti-coagulants
boolean
C0003280 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
ID.17
Item
any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence).
boolean
C0006826 (UMLS CUI [1])
ID.18
Item
any other contraindication to etanercept, methotrexate or parenteral depomedrone.
boolean
C0522473 (UMLS CUI [1,1])
C0717758 (UMLS CUI [1,2])
ID.19
Item
patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than twice the upper limit of normal, and serum creatinine >150 micromoles/litre.
boolean
C0201899 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
C0427547 (UMLS CUI [1,3])
C0600061 (UMLS CUI [1,4])
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