ID

13004

Description

TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00001862

Link

https://clinicaltrials.gov/show/NCT00001862

Keywords

  1. 1/11/16 1/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet american college of rheumatology criteria for jra.
Description

rheumatology criteria for jra

Data type

boolean

Alias
UMLS CUI [1]
C3714757
have active anterior uveitis defined as the presence of inflammatory cells (grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of tid or higher.
Description

active anterior uveitis

Data type

boolean

Alias
UMLS CUI [1]
C0042164
be between 2 and 18 years, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells.
Description

slit lamp biomicroscopy

Data type

boolean

Alias
UMLS CUI [1]
C0419360
be able to comply with study requirements.
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
be up to date on all recommended childhood immunizations.
Description

childhood immunizations

Data type

boolean

Alias
UMLS CUI [1]
C0020971
have been using current arthritis regimen for at least 8 weeks prior to enrollment.
Description

current arthritis regimen

Data type

boolean

Alias
UMLS CUI [1]
C0020971
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a media opacity that precludes assessment of anterior chamber inflammation.
Description

media opacity

Data type

boolean

Alias
UMLS CUI [1]
C0010038
have a periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation.
Description

periocular injection of corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0001617
be currently receiving disease modifying antirheumatic therapy (dmard), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week.
Description

disease modifying antirheumatic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003191
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0025677
have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
Description

inflammation

Data type

boolean

Alias
UMLS CUI [1]
C0021368
be a female who is pregnant or lactating .
Description

be a female who is pregnant or lactating .

Data type

boolean

Alias
UMLS CUI [1]
C0032961
refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
have used latanoprost within two weeks prior to enrollment, or have a current or likely need for latanoprost during the course of the study.
Description

latanoprost

Data type

boolean

Alias
UMLS CUI [1]
C0090306
have hypersensitivity to fluorescein dye.
Description

hypersensitivity to fluorescein dye

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0060520
have active serious infections or history of recurring serious infections.
Description

infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
evidence of spondyloarthropathy or entheseopathy.
Description

spondyloarthropathy or entheseopathy

Data type

boolean

Alias
UMLS CUI [1]
C0949691
UMLS CUI [2]
C0242490

Similar models

Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
rheumatology criteria for jra
Item
meet american college of rheumatology criteria for jra.
boolean
C3714757 (UMLS CUI [1])
active anterior uveitis
Item
have active anterior uveitis defined as the presence of inflammatory cells (grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of tid or higher.
boolean
C0042164 (UMLS CUI [1])
Age
Item
be between 2 and 18 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
slit lamp biomicroscopy
Item
be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells.
boolean
C0419360 (UMLS CUI [1])
compliance
Item
be able to comply with study requirements.
boolean
C1321605 (UMLS CUI [1])
childhood immunizations
Item
be up to date on all recommended childhood immunizations.
boolean
C0020971 (UMLS CUI [1])
current arthritis regimen
Item
have been using current arthritis regimen for at least 8 weeks prior to enrollment.
boolean
C0020971 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
media opacity
Item
have a media opacity that precludes assessment of anterior chamber inflammation.
boolean
C0010038 (UMLS CUI [1])
periocular injection of corticosteroids
Item
have a periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation.
boolean
C0001617 (UMLS CUI [1])
disease modifying antirheumatic therapy
Item
be currently receiving disease modifying antirheumatic therapy (dmard), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week.
boolean
C0003191 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
inflammation
Item
have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
boolean
C0021368 (UMLS CUI [1])
be a female who is pregnant or lactating .
Item
be a female who is pregnant or lactating .
boolean
C0032961 (UMLS CUI [1])
contraception
Item
refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists.
boolean
C0700589 (UMLS CUI [1])
latanoprost
Item
have used latanoprost within two weeks prior to enrollment, or have a current or likely need for latanoprost during the course of the study.
boolean
C0090306 (UMLS CUI [1])
hypersensitivity to fluorescein dye
Item
have hypersensitivity to fluorescein dye.
boolean
C0020517 (UMLS CUI [1,1])
C0060520 (UMLS CUI [1,2])
infections
Item
have active serious infections or history of recurring serious infections.
boolean
C0009450 (UMLS CUI [1])
spondyloarthropathy or entheseopathy
Item
evidence of spondyloarthropathy or entheseopathy.
boolean
C0949691 (UMLS CUI [1])
C0242490 (UMLS CUI [2])

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