ID

34557

Beschrijving

Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01559103

Link

https://clinicaltrials.gov/show/NCT01559103

Trefwoorden

  1. 19-01-19 19-01-19 -
Houder van rechten

see on clinicaltrials.gov

Geüploaded op

19 januari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01559103

Eligibility Rheumatoid Arthritis NCT01559103

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
active rheumatoid arthritis (ra) for 6 months or more.
Beschrijving

ID.1

Datatype

boolean

males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
Beschrijving

ID.2

Datatype

boolean

body mass index (bmi) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
Beschrijving

ID.3

Datatype

boolean

males, unless surgically sterile, must use 2 effective methods of birth control from day 1 through follow-up.
Beschrijving

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
Beschrijving

ID.5

Datatype

boolean

history of liver disease, bilirubin elevations, or gilbert's syndrome.
Beschrijving

ID.6

Datatype

boolean

any systematic inflammatory condition in addition to ra (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
Beschrijving

ID.7

Datatype

boolean

current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
Beschrijving

ID.8

Datatype

boolean

intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
Beschrijving

ID.9

Datatype

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT01559103

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
active rheumatoid arthritis (ra) for 6 months or more.
boolean
ID.2
Item
males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
boolean
ID.3
Item
body mass index (bmi) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
boolean
ID.4
Item
males, unless surgically sterile, must use 2 effective methods of birth control from day 1 through follow-up.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
history or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
boolean
ID.6
Item
history of liver disease, bilirubin elevations, or gilbert's syndrome.
boolean
ID.7
Item
any systematic inflammatory condition in addition to ra (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
boolean
ID.8
Item
current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
boolean
ID.9
Item
intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
boolean

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