Eligibility Juvenile Idiopathic Arthritis NCT01673919

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Visit Specified Completed | Benefit Due to Investigational Therapy
Item
patients who completed visit 33 (week 104) of wa19977 study and who may benefit from study drug treatment according to the investigator's assessment
boolean
C1512346 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0814225 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
RoActemra Infusion Scheduled | Actemra Infusion Scheduled
Item
patients have to receive the first roactemra/actemra infusion in this study at the week 8 visit at the latest
boolean
C3272237 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C2740854 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential | Gender Contraceptive methods
Item
females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
RoActemra Benefit Unsatisfactory | Actemra Benefit Unsatisfactory
Item
patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977
boolean
C3272237 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,3])
C2740854 (UMLS CUI [2,1])
C0814225 (UMLS CUI [2,2])
C0439856 (UMLS CUI [2,3])
Investigational New Drugs
Item
treatment with any investigational agent since the last administration of study drug in the core study wa19977
boolean
C0013230 (UMLS CUI [1])
Autoimmune Disease Rheumatic | Overlap syndrome | Exception Polyarticular Juvenile Idiopathic Arthritis, Rheumatoid Factor Positive | Exception Polyarticular Juvenile Idiopathic Arthritis, Rheumatoid Factor Negative | Exception Extended Oligoarticular Juvenile Idiopathic Arthritis
Item
patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course jia subsets: rheumatoid factor positive or negative jia or extended oligoarticular jia
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C0410000 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C3890733 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C3890205 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C3899192 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Comorbidity Significant | Medical condition Significant | Operative Surgical Procedure Significant
Item
any significant concomitant disease or medical or surgical condition
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Allergic Reaction Prior biologic therapy | Infusion related reaction Prior biologic therapy
Item
history of significant allergic or infusion reactions to prior biologic therapy
boolean
C1527304 (UMLS CUI [1,1])
C0278947 (UMLS CUI [1,2])
C0948715 (UMLS CUI [2,1])
C0278947 (UMLS CUI [2,2])
Immunodeficiency | Secondary immunodeficiency
Item
currently active primary or secondary immunodeficiency
boolean
C0021051 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
Communicable Diseases Medical contraindication RoActemra | Communicable Diseases Medical contraindication Actemra
Item
any infections with contraindications to roactemra/actemra therapy according to investigator judgment
boolean
C0009450 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C3272237 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C2740854 (UMLS CUI [2,3])
Liver function Inadequate | Renal function Inadequate | Bone Marrow function Inadequate
Item
inadequate hepatic, renal or bone marrow function
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])

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