Eligibility Juvenile Idiopathic Arthritis NCT02165345

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Specified Completed | Clinical Trial Polyarticular juvenile idiopathic arthritis | Clinical Trial SJIA
Item
completion of either of the jigsaw studies, study wa28117 (for patients with pcjia) or study wa28118 (for patients with sjia)
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C4521004 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C1384600 (UMLS CUI [3,2])
Disorder control RoActemra Subcutaneous | Disorder control Actemra Subcutaneous
Item
adequate disease control with the use of sc roactemra/actemra, as assessed by the investigator
boolean
C0920467 (UMLS CUI [1,1])
C3272237 (UMLS CUI [1,2])
C1522438 (UMLS CUI [1,3])
C0920467 (UMLS CUI [2,1])
C2740854 (UMLS CUI [2,2])
C1522438 (UMLS CUI [2,3])
Informed Consent | Age | Informed Consent Parent | Informed Consent Guardian
Item
written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Females & males of reproductive potential Contraceptive methods
Item
for patients of reproductive potential: use of effective contraception as defined by the study protocol
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Biological agents | Exception RoActemra | Exception Actemra
Item
therapy with biologic agents (except roactemra/actemra) in the period between completion of the jigsaw study and screening for the current study
boolean
C0005515 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3272237 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2740854 (UMLS CUI [3,2])
DMARDs allowed | Methotrexate allowed | NSAIDs allowed | Adrenal Cortex Hormones Oral allowed
Item
concurrent treatment with dmards (including mtx), nsaids, and oral corticosteroids is permitted at the discretion of the investigator
boolean
C0242708 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Vaccines, Attenuated | Immunosuppressive Agents | Cyclosporine | Cyclophosphamide
Item
use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited
boolean
C0042211 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity At risk Patient safety | Operative Surgical Procedures At risk Patient safety | Finding At risk Patient safety | Comorbidity Completion of clinical trial At risk | Operative Surgical Procedures Completion of clinical trial At risk | Finding Completion of clinical trial At risk | Nervous system disorder | Kidney Disease | Liver disease | Heart Disease | Lung disease | Stomach Disease | Endocrine System Disease
Item
any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C2732579 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C2732579 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0243095 (UMLS CUI [6,1])
C2732579 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0027765 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0024115 (UMLS CUI [11])
C0038354 (UMLS CUI [12])
C0014130 (UMLS CUI [13])
Substance Use Disorders | Chemical abuse
Item
history of alcohol, drug, or chemical abuse within 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C0851847 (UMLS CUI [2])
Tuberculosis Atypical | Tuberculosis Treatment required for
Item
history of atypical tuberculosis (tb) or active tb requiring treatment within 2 years prior to screening
boolean
C0041296 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0041296 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])

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