ID

34538

Description

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT01793259

Link

https://clinicaltrials.gov/show/NCT01793259

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 1/19/19 1/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01793259

English

Eligibility Rheumatoid Arthritis NCT01793259

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age between 18 and 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
rheumatoid arthritis according to the american college of rheumatology (acr) criteria 1987 or acr/european liga against rheumatology (eular)2010
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
disease activity score (das) 28 > 2.6
Description

Disease activity score 28 joint in rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C2732493
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior or other current subcutaneous treatment with self-injection
Description

Subcutaneous administration of treatment Self-injection

Data type

boolean

Alias
UMLS CUI [1,1]
C1273555
UMLS CUI [1,2]
C4296903
prior or concomitant treatment with biologics
Description

Biological agents

Data type

boolean

Alias
UMLS CUI [1]
C0005515
contraindications to mtx treatment
Description

Medical contraindication Methotrexate treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0746573
history or diagnosis of a dermatological disease at the injection site
Description

Dermatologic disorder Injection site

Data type

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C2700396
women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.
Description

Childbearing Potential Contraceptive methods Absent | Gender Partner Childbearing Potential | Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Rheumatoid Arthritis NCT01793259

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age between 18 and 75 years
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
rheumatoid arthritis according to the american college of rheumatology (acr) criteria 1987 or acr/european liga against rheumatology (eular)2010
boolean
C0003873 (UMLS CUI [1])
Disease activity score 28 joint in rheumatoid arthritis
Item
disease activity score (das) 28 > 2.6
boolean
C2732493 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Subcutaneous administration of treatment Self-injection
Item
prior or other current subcutaneous treatment with self-injection
boolean
C1273555 (UMLS CUI [1,1])
C4296903 (UMLS CUI [1,2])
Biological agents
Item
prior or concomitant treatment with biologics
boolean
C0005515 (UMLS CUI [1])
Medical contraindication Methotrexate treatment
Item
contraindications to mtx treatment
boolean
C1301624 (UMLS CUI [1,1])
C0746573 (UMLS CUI [1,2])
Dermatologic disorder Injection site
Item
history or diagnosis of a dermatological disease at the injection site
boolean
C0037274 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Absent | Gender Partner Childbearing Potential | Gender Contraceptive methods Absent
Item
women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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