ID

32491

Beschreibung

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA); ODM derived from: https://clinicaltrials.gov/show/NCT00886769

Link

https://clinicaltrials.gov/show/NCT00886769

Stichworte

Versionen (2)
  1. 04.11.18 04.11.18 -
  2. 05.11.18 05.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. November 2018

DOI

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Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

Englisch

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of systemic juvenile idiopathic arthritis as per ilar definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age:
Beschreibung

Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1384600
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C2599446
arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following:
Beschreibung

Arthritis Joints Quantity | Fever Daily Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015967
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0449238
evanescent nonfixed erythematous rash,
Beschreibung

Rash erythematous

Datentyp

boolean

Alias
UMLS CUI [1]
C0234913
generalized lymph node enlargement,
Beschreibung

Generalized enlarged lymph nodes

Datentyp

boolean

Alias
UMLS CUI [1]
C0476486
hepatomegaly and/ or splenomegaly,
Beschreibung

Hepatomegaly | Splenomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0019209
UMLS CUI [2]
C0038002
serositis
Beschreibung

Serositis

Datentyp

boolean

Alias
UMLS CUI [1]
C0036749
2. parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
Beschreibung

Informed Consent Parent | Informed Consent Legal Guardian | Assent Child | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
UMLS CUI [3,1]
C1879749
UMLS CUI [3,2]
C0008059
UMLS CUI [4]
C0021430
3. male and female patients aged ≥ 2 to < 20 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. active disease at the time of enrollment defined as follows:
Beschreibung

Active disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2707252
at least 2 joints with active arthritis
Beschreibung

Arthritis Joints Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
Beschreibung

Spiking temperature Intermittent fever Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424781
UMLS CUI [1,2]
C0277799
UMLS CUI [1,3]
C0449238
c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
Beschreibung

C-reactive protein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201657
5. naïve to canakinumab
Beschreibung

Therapy naive Canakinumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C2718773
6. other protocol defined inclusion criteria may apply
Beschreibung

Inclusion criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. pregnant or nursing (lactating) female patients
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
Beschreibung

Childbearing Potential | Exception Coitus Absent | Exception Use of Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009253
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0700589
3. history of hypersensitivity to study drug or to biologics.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Biological agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0005515
4. diagnosis of active macrophage-activation syndrome (mas) (ravelli, magni-manzoni and pistorio 2005) within the last 6 months
Beschreibung

Macrophage Activation Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1096155
5. with active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (hiv) infection, hepatitis b or hepatitis c infection
Beschreibung

Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0026946
UMLS CUI [3]
C0042769
UMLS CUI [4]
C1844383
UMLS CUI [5]
C1844384
UMLS CUI [6]
C1837066
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0019163
UMLS CUI [9]
C0019196
6. other protocol defined exclusion criteria may apply
Beschreibung

Exclusion Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease
Item
1. confirmed diagnosis of systemic juvenile idiopathic arthritis as per ilar definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age:
boolean
C1384600 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2599446 (UMLS CUI [2])
Arthritis Joints Quantity | Fever Daily Duration
Item
arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following:
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Rash erythematous
Item
evanescent nonfixed erythematous rash,
boolean
C0234913 (UMLS CUI [1])
Generalized enlarged lymph nodes
Item
generalized lymph node enlargement,
boolean
C0476486 (UMLS CUI [1])
Hepatomegaly | Splenomegaly
Item
hepatomegaly and/ or splenomegaly,
boolean
C0019209 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
Serositis
Item
serositis
boolean
C0036749 (UMLS CUI [1])
Informed Consent Parent | Informed Consent Legal Guardian | Assent Child | Informed Consent
Item
2. parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C1879749 (UMLS CUI [3,1])
C0008059 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
Age
Item
3. male and female patients aged ≥ 2 to < 20 years of age
boolean
C0001779 (UMLS CUI [1])
Active disease
Item
4. active disease at the time of enrollment defined as follows:
boolean
C2707252 (UMLS CUI [1])
Arthritis Joints Quantity
Item
at least 2 joints with active arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Spiking temperature Intermittent fever Duration
Item
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
boolean
C0424781 (UMLS CUI [1,1])
C0277799 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C-reactive protein measurement
Item
c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
boolean
C0201657 (UMLS CUI [1])
Therapy naive Canakinumab
Item
5. naïve to canakinumab
boolean
C0919936 (UMLS CUI [1,1])
C2718773 (UMLS CUI [1,2])
Inclusion criteria Study Protocol
Item
6. other protocol defined inclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. pregnant or nursing (lactating) female patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Coitus Absent | Exception Use of Contraceptive methods
Item
2. female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009253 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Biological agents
Item
3. history of hypersensitivity to study drug or to biologics.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
Macrophage Activation Syndrome
Item
4. diagnosis of active macrophage-activation syndrome (mas) (ravelli, magni-manzoni and pistorio 2005) within the last 6 months
boolean
C1096155 (UMLS CUI [1])
Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C
Item
5. with active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (hiv) infection, hepatitis b or hepatitis c infection
boolean
C0004623 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C1844383 (UMLS CUI [4])
C1844384 (UMLS CUI [5])
C1837066 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
C0019196 (UMLS CUI [9])
Exclusion Criteria Study Protocol
Item
6. other protocol defined exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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