ID

12559

Beschrijving

Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA); ODM derived from: https://clinicaltrials.gov/show/NCT00570661

Link

https://clinicaltrials.gov/show/NCT00570661

Trefwoorden

Versies (1)
  1. 30-11-15 30-11-15 -
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30 november 2015

DOI

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Creative Commons BY 4.0
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Eligibility Active Systemic Onset JIA NCT00570661

Engels

Eligibility Active Systemic NCT00570661

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
established diagnosis of systemic sojia according to ilar criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
Beschrijving

Systemic onset JIA

Datatype

boolean

Alias
UMLS CUI [1]
C1384600
active disease for at least one month prior to enrolment as defined by the following criteria:
Beschrijving

active disease

Datatype

boolean

Alias
UMLS CUI [1]
C2707252
presence of arthritis plus at least one of the following:
Beschrijving

presence of arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003864
fever, defined as a body temperature >= 37,5 c degree at least once a day during at least five consecutive days or presence of typical sojia intermittent temperature chart
Beschrijving

fever defined as a body temperature >= 37,5 c degree

Datatype

boolean

Alias
UMLS CUI [1]
C0015967
rash, defined by presence of typical sojia salmon pink rash on the trunk and elsewhere during the febrile episodes
Beschrijving

salmon pink rash during the febrile episodes

Datatype

boolean

Alias
UMLS CUI [1]
C2081434
serositis (pericarditis, pleuritis, peritonitis) confirmed by ultrasound and/or x-ray exploration or by presence of typical ecg findings in the case of pericarditis
Beschrijving

serositis

Datatype

boolean

Alias
UMLS CUI [1]
C0036749
UMLS CUI [2]
C0032231
UMLS CUI [3]
C0031046
lymphadenopathy, defined by lymph nodes enlargement to 1,5 cm or more localized anywhere within the body, and/or hepatomegaly and/or splenomegaly, confirmed by ultrasound evaluation and established after comparison to age standards for organ size
Beschrijving

lymphadenopathy,hepatomegaly,splenomegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0497156
UMLS CUI [2]
C0019209
UMLS CUI [3]
C0038002
esr >= 20 mm/h (first hour) and/or crp >= 10 mg/l. in the absence of arthritis, two definite or one definite and one probable diagnostic criteria plus esr >=20 mm/h (first hour) and/or crp >=10 mg/l
Beschrijving

esr >= 20 mm/h (first hour) and/or crp >= 10 mg/l. in the absence of arthritis, two definite or one definite and one probable diagnostic criteria plus esr >=20 mm/h (first hour) and/or crp >=10 mg/l

Datatype

boolean

Alias
UMLS CUI [1]
C1176468
UMLS CUI [2]
C0201657
UMLS CUI [3]
C0679228
age at enrolment between 2 and 25 years
Beschrijving

age at enrolment

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2348568
age at first sojia diagnosis < 16 years
Beschrijving

age at first sojia diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0011900
previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to >= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
Beschrijving

previously introduced standard treatment of disease with steroids without satisfactory effect

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1442989
6. in case of concomitant methotrexate treatment, it has to be on stable dose >= 10mg/m2 weekly for al least 4 weeks before pt enrollment
Beschrijving

methotrexate treatment on stable dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0746573
UMLS CUI [1,2]
C0205360
previous treatment with biologics, if any, during at least three months without satisfactory effect or with drug intolerability, discontinued for at least the period specified below before patient's enrolment:
Beschrijving

previous treatment with biologics discontinued for at least the period specified below

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1744706
UMLS CUI [3]
C0005527
two months for etanercept
Beschrijving

etanercept

Datatype

boolean

Alias
UMLS CUI [1]
C0717758
six months for infliximab
Beschrijving

infliximab

Datatype

boolean

Alias
UMLS CUI [1]
C0666743
other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half lives
Beschrijving

other disease-modifying anti-rheumatic drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0242708
concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient's enrolment
Beschrijving

nonsteroidal anti-inflammatory drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205360
female of childbearing potential, using safe contraceptive measures
Beschrijving

contraceptive measures

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
signed written informed consent before starting any study procedure
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing clinical relevant viral infection
Beschrijving

eg.: herpes zoster, ebstein barr, cmv, systemic fungal infections or history of recurrent serious bacterial infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
history of macrophage activation syndrome
Beschrijving

macrophage activation syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C1096155
clinically significant illness i.e. any condition (including laboratory abnormalities) that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
Beschrijving

clinically significant illness that places the patient to unacceptable risk

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
4. psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
Beschrijving

psychiatric illness/social situations that would limit compliance with study medication and protocol requirements

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
congenital heart and/or central nervous system disorders
Beschrijving

congenital heart and/or central nervous system disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0852095
UMLS CUI [2]
C0152021
inherited metabolic diseases
Beschrijving

inherited metabolic diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019247
UMLS CUI [1,2]
C0025517
positive serological testing for anti hcv, anti hiv and hbsag (to be performed at screening)
Beschrijving

positive serological testing for anti hcv, anti hiv and hbsag

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0149709
pregnant or lactating women
Beschrijving

pregnant or lactating women

Datatype

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
presence of malignancy
Beschrijving

presence of malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
Beschrijving

coronary disease, cardiac rhythm abnormalities or congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018802
qtc interval > 450 msec at screening evaluation
Beschrijving

qtc interval

Datatype

boolean

Alias
UMLS CUI [1]
C0489625
serum magnesium and potassium below the lln at screening
Beschrijving

serum magnesium and potassium below the lln at screening

Datatype

boolean

Alias
UMLS CUI [1]
C0202125
UMLS CUI [2]
C0302353
unavoidable concomitant treatment with any drug known for potential risk of causing torsades de pointes
Beschrijving

concomitant treatment with any drug known for potential risk of causing torsades de pointes

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0040479
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Similar models

Eligibility Active Systemic NCT00570661

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Systemic onset JIA
Item
established diagnosis of systemic sojia according to ilar criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents.
boolean
C1384600 (UMLS CUI [1])
active disease
Item
active disease for at least one month prior to enrolment as defined by the following criteria:
boolean
C2707252 (UMLS CUI [1])
presence of arthritis
Item
presence of arthritis plus at least one of the following:
boolean
C0003864 (UMLS CUI [1])
fever defined as a body temperature >= 37,5 c degree
Item
fever, defined as a body temperature >= 37,5 c degree at least once a day during at least five consecutive days or presence of typical sojia intermittent temperature chart
boolean
C0015967 (UMLS CUI [1])
salmon pink rash during the febrile episodes
Item
rash, defined by presence of typical sojia salmon pink rash on the trunk and elsewhere during the febrile episodes
boolean
C2081434 (UMLS CUI [1])
serositis
Item
serositis (pericarditis, pleuritis, peritonitis) confirmed by ultrasound and/or x-ray exploration or by presence of typical ecg findings in the case of pericarditis
boolean
C0036749 (UMLS CUI [1])
C0032231 (UMLS CUI [2])
C0031046 (UMLS CUI [3])
lymphadenopathy,hepatomegaly,splenomegaly
Item
lymphadenopathy, defined by lymph nodes enlargement to 1,5 cm or more localized anywhere within the body, and/or hepatomegaly and/or splenomegaly, confirmed by ultrasound evaluation and established after comparison to age standards for organ size
boolean
C0497156 (UMLS CUI [1])
C0019209 (UMLS CUI [2])
C0038002 (UMLS CUI [3])
esr >= 20 mm/h (first hour) and/or crp >= 10 mg/l. in the absence of arthritis, two definite or one definite and one probable diagnostic criteria plus esr >=20 mm/h (first hour) and/or crp >=10 mg/l
Item
esr >= 20 mm/h (first hour) and/or crp >= 10 mg/l. in the absence of arthritis, two definite or one definite and one probable diagnostic criteria plus esr >=20 mm/h (first hour) and/or crp >=10 mg/l
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
C0679228 (UMLS CUI [3])
age at enrolment
Item
age at enrolment between 2 and 25 years
boolean
C0001779 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
age at first sojia diagnosis
Item
age at first sojia diagnosis < 16 years
boolean
C0001779 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
previously introduced standard treatment of disease with steroids without satisfactory effect
Item
previously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to >= 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient's enrolment
boolean
C0040808 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
methotrexate treatment on stable dose
Item
6. in case of concomitant methotrexate treatment, it has to be on stable dose >= 10mg/m2 weekly for al least 4 weeks before pt enrollment
boolean
C0746573 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
previous treatment with biologics discontinued for at least the period specified below
Item
previous treatment with biologics, if any, during at least three months without satisfactory effect or with drug intolerability, discontinued for at least the period specified below before patient's enrolment:
boolean
C2347852 (UMLS CUI [1])
C1744706 (UMLS CUI [2])
C0005527 (UMLS CUI [3])
etanercept
Item
two months for etanercept
boolean
C0717758 (UMLS CUI [1])
infliximab
Item
six months for infliximab
boolean
C0666743 (UMLS CUI [1])
other disease-modifying anti-rheumatic drugs
Item
other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half lives
boolean
C0242708 (UMLS CUI [1])
nonsteroidal anti-inflammatory drugs
Item
concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient's enrolment
boolean
C0003211 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
contraceptive measures
Item
female of childbearing potential, using safe contraceptive measures
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
signed written informed consent before starting any study procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
viral infection
Item
ongoing clinical relevant viral infection
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
macrophage activation syndrome
Item
history of macrophage activation syndrome
boolean
C1096155 (UMLS CUI [1])
clinically significant illness that places the patient to unacceptable risk
Item
clinically significant illness i.e. any condition (including laboratory abnormalities) that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
Item
4. psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
congenital heart and/or central nervous system disorders
Item
congenital heart and/or central nervous system disorders
boolean
C0852095 (UMLS CUI [1])
C0152021 (UMLS CUI [2])
inherited metabolic diseases
Item
inherited metabolic diseases
boolean
C0019247 (UMLS CUI [1,1])
C0025517 (UMLS CUI [1,2])
positive serological testing for anti hcv, anti hiv and hbsag
Item
positive serological testing for anti hcv, anti hiv and hbsag (to be performed at screening)
boolean
C0019699 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
pregnant or lactating women
Item
pregnant or lactating women
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
presence of malignancy
Item
presence of malignancy
boolean
C0006826 (UMLS CUI [1])
coronary disease, cardiac rhythm abnormalities or congestive heart failure
Item
any previous evidence, irrespective of its severity, of coronary disease, cardiac rhythm abnormalities or congestive heart failure
boolean
C0010068 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
qtc interval
Item
qtc interval > 450 msec at screening evaluation
boolean
C0489625 (UMLS CUI [1])
serum magnesium and potassium below the lln at screening
Item
serum magnesium and potassium below the lln at screening
boolean
C0202125 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
concomitant treatment with any drug known for potential risk of causing torsades de pointes
Item
unavoidable concomitant treatment with any drug known for potential risk of causing torsades de pointes
boolean
C2347852 (UMLS CUI [1])
C0040479 (UMLS CUI [2])
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