Eligibility Juvenile Idiopathic Arthritis NCT01727986

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Visit Specified Completed | Juvenile arthritis | Clinical Response RoActemra | Clinical Response Actemra | Absent Adverse Event | Adverse event Severe Absent
Item
patients 9 to 18 years of age who completed visit 33 (week 104) of wa19977 study with at least jia acr30 clinical response to roactemra/actemra relative to baseline in wa19977, with no aes, saes or conditions that lead to unacceptable risk of continued treatment
boolean
C0001779 (UMLS CUI [1])
C1512346 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C3495559 (UMLS CUI [3])
C4055223 (UMLS CUI [4,1])
C3272237 (UMLS CUI [4,2])
C4055223 (UMLS CUI [5,1])
C2740854 (UMLS CUI [5,2])
C2699517 (UMLS CUI [6])
C0877248 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
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 | Study Subject Participation Status | Clinical Trial
Item
treatment with any investigational agent since the last administration of study drug in the core study wa19977 or current participation in another clinical trial except wa19977
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
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])
Substance Use Disorders | Chemical abuse
Item
current abuse of alcohol, drugs or chemical abuse
boolean
C0038586 (UMLS CUI [1])
C0851847 (UMLS CUI [2])
Communicable Disease | Subacute infectious disease | Chronic infectious disease | Recurrent infection | Epstein-Barr Virus Infection allowed | Herpes zoster disease allowed | Recurrent urinary tract infection allowed
Item
known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with epstein barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
boolean
C0009450 (UMLS CUI [1])
C0275519 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0239998 (UMLS CUI [4])
C0149678 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0019360 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0262655 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
Latent Tuberculosis Positive
Item
positive for latent tuberculosis (tb)
boolean
C1609538 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Asthma | Patient need for Adrenal Cortex Hormones Oral | Patient need for Adrenal Cortex Hormones Parenteral
Item
currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study
boolean
C0004096 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1518896 (UMLS CUI [3,3])
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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