ID

32493

Description

An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.; ODM derived from: https://clinicaltrials.gov/show/NCT00891046

Link

https://clinicaltrials.gov/show/NCT00891046

Keywords

Versions (1)
  1. 11/5/18 11/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic Juvenile Idiopathic Arthritis NCT00891046

English

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00891046

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients from study cacz885g2305 or cacz885g2301 who achieved an adapted acr pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum acr pediatric 30 response was not maintained after day 15 and intervention is deemed necessary by the investigator, or patients in study cacz885g2301 who are not eligible to enter part ii (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or responder patients in part i or part ii who had not flared when cacz885g2301 was stopped, or cacz885g2301 patients who were responders in part i but experienced a flare in part ii.
Description

Patients Clinical Trial Specified | Response ACR Improvement Criteria | Canakinumab Dose Initial | Clinical Deterioration | Patient need for Intervention | Adrenal Cortex Hormones Criteria failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C3273747
UMLS CUI [3,1]
C2718773
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205265
UMLS CUI [4]
C4505323
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0184661
UMLS CUI [6,1]
C0001617
UMLS CUI [6,2]
C0243161
UMLS CUI [6,3]
C0231175
treatment-naïve patients need to meet the following criteria:
Description

Therapy naive | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1384600
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C2599446
male and female patients aged ≥ 2 to < 20 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
active disease at the time of enrollment defined as having 2 or more of the following:
Description

Active disease

Data type

boolean

Alias
UMLS CUI [1]
C2707252
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day during the screening period and within 1 week before first canakinumab dose
Description

Spiking temperature Intermittent fever Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0424781
UMLS CUI [1,2]
C0277799
UMLS CUI [1,3]
C0449238
at least 2 joints with active arthritis
Description

Arthritis Joints Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
and c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l) rash serositis lymphadenopathy hepatosplenomegaly
Description

C-reactive protein measurement | Exanthema | Serositis | Lymphadenopathy | Hepatosplenomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0015230
UMLS CUI [3]
C0036749
UMLS CUI [4]
C0497156
UMLS CUI [5]
C0019214
naïve to canakinumab
Description

Therapy naive Canakinumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C2718773
other protocol-defined inclusion criteria may apply
Description

Inclusion criteria Study Protocol

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergy or hypersensitivity to study drug
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
with active or recurrent bacterial, fungal or viral infections at time of enrollment
Description

Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection

Data type

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
other protocol inclusion/exclusion criteria may apply
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Systemic Juvenile Idiopathic Arthritis NCT00891046

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Clinical Trial Specified | Response ACR Improvement Criteria | Canakinumab Dose Initial | Clinical Deterioration | Patient need for Intervention | Adrenal Cortex Hormones Criteria failed
Item
patients from study cacz885g2305 or cacz885g2301 who achieved an adapted acr pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum acr pediatric 30 response was not maintained after day 15 and intervention is deemed necessary by the investigator, or patients in study cacz885g2301 who are not eligible to enter part ii (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or responder patients in part i or part ii who had not flared when cacz885g2301 was stopped, or cacz885g2301 patients who were responders in part i but experienced a flare in part ii.
boolean
C0030705 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C3273747 (UMLS CUI [2,2])
C2718773 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205265 (UMLS CUI [3,3])
C4505323 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C0184661 (UMLS CUI [5,2])
C0001617 (UMLS CUI [6,1])
C0243161 (UMLS CUI [6,2])
C0231175 (UMLS CUI [6,3])
Therapy naive | Criteria Fulfill
Item
treatment-naïve patients need to meet the following criteria:
boolean
C0919936 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease
Item
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])
Age
Item
male and female patients aged ≥ 2 to < 20 years of age
boolean
C0001779 (UMLS CUI [1])
Active disease
Item
active disease at the time of enrollment defined as having 2 or more of the following:
boolean
C2707252 (UMLS CUI [1])
Spiking temperature Intermittent fever Duration
Item
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day during the screening period and within 1 week before first canakinumab dose
boolean
C0424781 (UMLS CUI [1,1])
C0277799 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
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])
C-reactive protein measurement | Exanthema | Serositis | Lymphadenopathy | Hepatosplenomegaly
Item
and c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l) rash serositis lymphadenopathy hepatosplenomegaly
boolean
C0201657 (UMLS CUI [1])
C0015230 (UMLS CUI [2])
C0036749 (UMLS CUI [3])
C0497156 (UMLS CUI [4])
C0019214 (UMLS CUI [5])
Therapy naive Canakinumab
Item
naïve to canakinumab
boolean
C0919936 (UMLS CUI [1,1])
C2718773 (UMLS CUI [1,2])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
history of allergy or hypersensitivity to study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection
Item
with active or recurrent bacterial, fungal or viral infections at time of enrollment
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])
Exclusion Criteria Study Protocol
Item
other protocol inclusion/exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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