ID

40508

Description

A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA); ODM derived from: https://clinicaltrials.gov/show/NCT01544114

Link

https://clinicaltrials.gov/show/NCT01544114

Keywords

Versions (1)
  1. 4/28/20 4/28/20 -
Copyright Holder

See clinicaltrials.gov

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April 28, 2020

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License

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis (JIA) NCT01544114

English

Eligibility Juvenile Idiopathic Arthritis (JIA) NCT01544114

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
Description

Informed Consent Parent | Informed Consent Legal Guardian | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
UMLS CUI [3]
C0021430
male and female adolescents aged 12 to 16 years at the time of enrollment.
Description

Adolescent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0205653
UMLS CUI [2]
C0001779
diagnosed with jia, including all the ilar jia subtypes: oligoarthritis, polyarthritis (both rf+ and rf-), psoriatic arthritis, enthesitis-related arthritis,undifferentiated arthritis, and systemic arthritis.
Description

Juvenile arthritis | Oligoarticular Arthritis | Polyarthritis Rheumatoid factor positive | Polyarthritis Rheumatoid factor negative | Arthritis, Psoriatic | Enthesitis-Related Arthritis | Undifferentiated Juvenile Idiopathic Arthritis | Systemic onset juvenile chronic arthritis

Data type

boolean

Alias
UMLS CUI [1]
C3495559
UMLS CUI [2]
C3892044
UMLS CUI [3,1]
C0162323
UMLS CUI [3,2]
C0151379
UMLS CUI [4,1]
C0162323
UMLS CUI [4,2]
C0427391
UMLS CUI [5]
C0003872
UMLS CUI [6]
C3495919
UMLS CUI [7]
C3897245
UMLS CUI [8]
C1384600
based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with vimovo.
Description

Vimovo

Data type

boolean

Alias
UMLS CUI [1]
C2918032
body weight >31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.
Description

Body Weight | Body mass index percentile per age

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C3838397
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
in systemic jia patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
Description

Systemic onset juvenile chronic arthritis | Feature Systemic | Fever | Exanthema | Other Coding | Serositis | Lymphadenopathy | Macrophage Activation Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1384600
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0015967
UMLS CUI [4]
C0015230
UMLS CUI [5]
C3846158
UMLS CUI [6]
C0036749
UMLS CUI [7]
C0497156
UMLS CUI [8]
C1096155
currently taking (ie, within 4 weeks prior to start of drug) naproxen >20 mg/kg/day or >1000 mg total daily dose.
Description

Naproxen U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0027396
UMLS CUI [1,2]
C0456683
hemoglobin ≤8.5 g/dl.
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
Description

Cardiovascular Disease | Cerebrovascular Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.
Description

Liver diseases | Kidney Diseases | Lung diseases | Disorder of eye | Nervous system disorder | Other medical condition At risk Patient | Medical History | History of prior surgery | Physical Examination | Laboratory examination

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0015397
UMLS CUI [5]
C0027765
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0030705
UMLS CUI [7]
C0262926
UMLS CUI [8]
C0744961
UMLS CUI [9]
C0031809
UMLS CUI [10]
C0260877
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Similar models

Eligibility Juvenile Idiopathic Arthritis (JIA) NCT01544114

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent Parent | Informed Consent Legal Guardian | Informed Consent
Item
parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Adolescent | Age
Item
male and female adolescents aged 12 to 16 years at the time of enrollment.
boolean
C0205653 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Juvenile arthritis | Oligoarticular Arthritis | Polyarthritis Rheumatoid factor positive | Polyarthritis Rheumatoid factor negative | Arthritis, Psoriatic | Enthesitis-Related Arthritis | Undifferentiated Juvenile Idiopathic Arthritis | Systemic onset juvenile chronic arthritis
Item
diagnosed with jia, including all the ilar jia subtypes: oligoarthritis, polyarthritis (both rf+ and rf-), psoriatic arthritis, enthesitis-related arthritis,undifferentiated arthritis, and systemic arthritis.
boolean
C3495559 (UMLS CUI [1])
C3892044 (UMLS CUI [2])
C0162323 (UMLS CUI [3,1])
C0151379 (UMLS CUI [3,2])
C0162323 (UMLS CUI [4,1])
C0427391 (UMLS CUI [4,2])
C0003872 (UMLS CUI [5])
C3495919 (UMLS CUI [6])
C3897245 (UMLS CUI [7])
C1384600 (UMLS CUI [8])
Vimovo
Item
based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with vimovo.
boolean
C2918032 (UMLS CUI [1])
Body Weight | Body mass index percentile per age
Item
body weight >31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.
boolean
C0005910 (UMLS CUI [1])
C3838397 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic onset juvenile chronic arthritis | Feature Systemic | Fever | Exanthema | Other Coding | Serositis | Lymphadenopathy | Macrophage Activation Syndrome
Item
in systemic jia patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
boolean
C1384600 (UMLS CUI [1])
C2348519 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0015967 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0036749 (UMLS CUI [6])
C0497156 (UMLS CUI [7])
C1096155 (UMLS CUI [8])
Naproxen U/day
Item
currently taking (ie, within 4 weeks prior to start of drug) naproxen >20 mg/kg/day or >1000 mg total daily dose.
boolean
C0027396 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin ≤8.5 g/dl.
boolean
C0518015 (UMLS CUI [1])
Cardiovascular Disease | Cerebrovascular Disorder
Item
individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Liver diseases | Kidney Diseases | Lung diseases | Disorder of eye | Nervous system disorder | Other medical condition At risk Patient | Medical History | History of prior surgery | Physical Examination | Laboratory examination
Item
any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0015397 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C3843040 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0030705 (UMLS CUI [6,3])
C0262926 (UMLS CUI [7])
C0744961 (UMLS CUI [8])
C0031809 (UMLS CUI [9])
C0260877 (UMLS CUI [10])
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