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])
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])