Information:
Error:
Eligibility Juvenile Idiopathic Arthritis NCT02277444
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Juvenile arthritis
Item
diagnosis must be made per juvenile idiopathic arthritis (jia) international league of associations for rheumatology (ilar) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
boolean
C3495559 (UMLS CUI [1])
Methotrexate failed | Methotrexate Response Inadequate
Item
failure or inadequate response to at least a 3 month course of methotrexate (mtx) before screening
boolean
C0025677 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0231175 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Joints Quantity Arthritis
Item
participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at week 0 as defined by american college of rheumatology (acr) criteria
boolean
C0022417 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C-reactive protein measurement
Item
participants must have a screening c-reactive protein (crp) of >=0.1 milligram (mg)/deciliter (dl)
boolean
C0201657 (UMLS CUI [1])
Juvenile arthritis | Methotrexate Oral | Methotrexate Intramuscular | Methotrexate Subcutaneous | Methotrexate Dose Stable U/week | Relationship Body Surface Area
Item
participants must have active jia despite current use of oral, intramuscular or subcutaneous mtx (for >=3 months before screening and on a stable dose for 4 weeks) at a weekly dose of >=10 mg/meter (m)^2. participants currently on mtx (weekly 10 to 30 mg/m^2), must receive a stable dose of mtx for >=4 weeks before screening. participants with body surface area (bsa) >=1.67 m^2 must receive a minimum of 15 mg/week of mtx unless documented country or site regulations prohibit use of 15 mg of mtx per week in participants with bsa >=1.67 m^2. in situations where there is documented intolerance of doses greater than (>) 10 mg/m^2 weekly or 15 mg/week for participants with bsa >=1.67 m^2, participants may be entered into the trial on a lower dose of mtx
boolean
C3495559 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C0025677 (UMLS CUI [4,1])
C1522438 (UMLS CUI [4,2])
C0025677 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0560588 (UMLS CUI [5,4])
C0439849 (UMLS CUI [6,1])
C0005902 (UMLS CUI [6,2])
C0025677 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C0025677 (UMLS CUI [4,1])
C1522438 (UMLS CUI [4,2])
C0025677 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0560588 (UMLS CUI [5,4])
C0439849 (UMLS CUI [6,1])
C0005902 (UMLS CUI [6,2])
Antirheumatic Drugs, Disease-Modifying | Therapeutic immunosuppression
Item
participant has initiated disease-modifying antirheumatic drugs (dmards) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
boolean
C0242708 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0021079 (UMLS CUI [2])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Corticotropin Intramuscular
Item
participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001655 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001655 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
Pharmaceutical Preparations Reducing Interleukin-12 | Pharmaceutical Preparations Reducing Interleukin-23 | ustekinumab | ABT-874
Item
participant has been treated with any therapeutic agent targeted at reducing interleukin (il)-12 or il 23, including but not limited to ustekinumab and abt-874
boolean
C0013227 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0123759 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0963088 (UMLS CUI [2,3])
C1608841 (UMLS CUI [3])
C2604734 (UMLS CUI [4])
C0392756 (UMLS CUI [1,2])
C0123759 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0963088 (UMLS CUI [2,3])
C1608841 (UMLS CUI [3])
C2604734 (UMLS CUI [4])
natalizumab | efalizumab | Pharmaceutical Preparations Reducing B-Lymphocytes | Pharmaceutical Preparations Reducing T-Lymphocyte | rituximab | alemtuzumab | visilizumab
Item
participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete b or t cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
boolean
C1172734 (UMLS CUI [1])
C1174995 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C0004561 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
C0039194 (UMLS CUI [4,3])
C0393022 (UMLS CUI [5])
C0383429 (UMLS CUI [6])
C3887822 (UMLS CUI [7])
C1174995 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C0004561 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
C0039194 (UMLS CUI [4,3])
C0393022 (UMLS CUI [5])
C0383429 (UMLS CUI [6])
C3887822 (UMLS CUI [7])
alefacept
Item
participant has been treated with alefacept within 3 months before first study agent administration
boolean
C0962603 (UMLS CUI [1])