ID

32491

Descripción

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

Palabras clave

Versiones (2)
  1. 4/11/18 4/11/18 -
  2. 5/11/18 5/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

Inglés

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

1 formularios  
Inclusion Criteria
Descripción

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:
Descripción

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

Tipo de datos

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:
Descripción

Arthritis Joints Quantity | Fever Daily Duration

Tipo de datos

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,
Descripción

Rash erythematous

Tipo de datos

boolean

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

Generalized enlarged lymph nodes

Tipo de datos

boolean

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

Hepatomegaly | Splenomegaly

Tipo de datos

boolean

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

Serositis

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Age

Tipo de datos

boolean

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

Active disease

Tipo de datos

boolean

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

Arthritis Joints Quantity

Tipo de datos

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
Descripción

Spiking temperature Intermittent fever Duration

Tipo de datos

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)
Descripción

C-reactive protein measurement

Tipo de datos

boolean

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

Therapy naive Canakinumab

Tipo de datos

boolean

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

Inclusion criteria Study Protocol

Tipo de datos

boolean

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

Exclusion Criteria

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

Criteria Fulfill

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Biological agents

Tipo de datos

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
Descripción

Macrophage Activation Syndrome

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
Volver a la parte superior de la página

Similar models

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00886769

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial