ID

13004

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00001862

Nyckelord

  1. 2016-01-11 2016-01-11 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

11 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

rheumatology criteria for jra

Datatyp

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.
Beskrivning

active anterior uveitis

Datatyp

boolean

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

Age

Datatyp

boolean

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

slit lamp biomicroscopy

Datatyp

boolean

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

compliance

Datatyp

boolean

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

childhood immunizations

Datatyp

boolean

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

current arthritis regimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0020971
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

media opacity

Datatyp

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.
Beskrivning

periocular injection of corticosteroids

Datatyp

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.
Beskrivning

disease modifying antirheumatic therapy

Datatyp

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.
Beskrivning

inflammation

Datatyp

boolean

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

be a female who is pregnant or lactating .

Datatyp

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.
Beskrivning

contraception

Datatyp

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.
Beskrivning

latanoprost

Datatyp

boolean

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

hypersensitivity to fluorescein dye

Datatyp

boolean

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

infections

Datatyp

boolean

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

spondyloarthropathy or entheseopathy

Datatyp

boolean

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

Similar models

Eligibility Juvenile Rheumatoid Arthritis NCT00001862

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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