Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease
Item
confirmed diagnosis of systemic juvenile idiopathic arthritis as per international league against rheumatism (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 | Associated symptoms
Item
arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
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])
C0521989 (UMLS CUI [3])
Active disease
Item
active disease at the time of enrollment defined as follows:
boolean
C2707252 (UMLS CUI [1])
Arthritis Joints Quantity | Active joint count ACR Improvement Criteria
Item
at least 2 joints with active arthritis (using american college of rheumatology) acr definition of active joint)
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4067216 (UMLS CUI [2,1])
C3273747 (UMLS CUI [2,2])
Spiking temperature Intermittent fever Duration
Item
documented spiking, intermittent fever (body temperature > 38oc) for at least 1 day during the screening period within 1 week before first study drug 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 > 30 mg/l (normal range < 10 mg/l)
boolean
C0201657 (UMLS CUI [1])
Second line Pharmaceutical Preparations Excluded | Biological Response Modifiers Excluded | Immunosuppressive Agents Excluded
Item
no concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
boolean
C1710038 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Exception | Methotrexate Dose Stable | Folic Acid | Folinic acid
Item
stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
boolean
C1705847 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0016410 (UMLS CUI [3])
C0023413 (UMLS CUI [4])
Exception | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable
Item
stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
boolean
C1705847 (UMLS CUI [1])
C0003211 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Exception | Steroid therapy Dose Stable | Prednisone Oral U/day | Prednisone Oral U/day Equivalent
Item
stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
boolean
C1705847 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C3216040 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C3216040 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
Macrophage Activation Syndrome
Item
diagnosis of active macrophage-activation syndrome (mas) within the last 6 months
boolean
C1096155 (UMLS CUI [1])
Tuberculosis risk factors
Item
risk factors for tuberculosis
boolean
C0749721 (UMLS CUI [1])
Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C
Item
patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of hiv infection, hepatitis b and 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])
Eligibility Criteria Study Protocol
Item
other protocol inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])