ID

40517

Beschreibung

An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study; ODM derived from: https://clinicaltrials.gov/show/NCT01727986

Link

https://clinicaltrials.gov/show/NCT01727986

Stichworte

  1. 29.04.20 29.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. April 2020

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Juvenile Idiopathic Arthritis NCT01727986

Eligibility Juvenile Idiopathic Arthritis NCT01727986

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beschreibung

Age | Visit Specified Completed | Juvenile arthritis | Clinical Response RoActemra | Clinical Response Actemra | Absent Adverse Event | Adverse event Severe Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1512346
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C0205197
UMLS CUI [3]
C3495559
UMLS CUI [4,1]
C4055223
UMLS CUI [4,2]
C3272237
UMLS CUI [5,1]
C4055223
UMLS CUI [5,2]
C2740854
UMLS CUI [6]
C2699517
UMLS CUI [7,1]
C0877248
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0332197
females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Beschreibung

Childbearing Potential Contraceptive methods | Gender Partner Childbearing Potential | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977
Beschreibung

RoActemra Benefit Unsatisfactory | Actemra Benefit Unsatisfactory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272237
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0439856
UMLS CUI [2,1]
C2740854
UMLS CUI [2,2]
C0814225
UMLS CUI [2,3]
C0439856
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
Beschreibung

Investigational New Drugs | Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0008976
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2]
C0410000
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3890733
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3890205
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3899192
patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
any significant concomitant disease or medical or surgical condition
Beschreibung

Comorbidity Significant | Medical condition Significant | Operative Surgical Procedure Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0750502
history of significant allergic or infusion reactions to prior biologic therapy
Beschreibung

Allergic Reaction Prior biologic therapy | Infusion related reaction Prior biologic therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0278947
UMLS CUI [2,1]
C0948715
UMLS CUI [2,2]
C0278947
currently active primary or secondary immunodeficiency
Beschreibung

Immunodeficiency | Secondary immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0398795
current abuse of alcohol, drugs or chemical abuse
Beschreibung

Substance Use Disorders | Chemical abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0851847
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
Beschreibung

Communicable Disease | Subacute infectious disease | Chronic infectious disease | Recurrent infection | Epstein-Barr Virus Infection allowed | Herpes zoster disease allowed | Recurrent urinary tract infection allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0275519
UMLS CUI [3]
C0151317
UMLS CUI [4]
C0239998
UMLS CUI [5,1]
C0149678
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0019360
UMLS CUI [6,2]
C0683607
UMLS CUI [7,1]
C0262655
UMLS CUI [7,2]
C0683607
positive for latent tuberculosis (tb)
Beschreibung

Latent Tuberculosis Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1609538
UMLS CUI [1,2]
C1514241
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
Beschreibung

Asthma | Patient need for Adrenal Cortex Hormones Oral | Patient need for Adrenal Cortex Hormones Parenteral

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C1518896
inadequate hepatic, renal or bone marrow function
Beschreibung

Liver function Inadequate | Renal function Inadequate | Bone Marrow function Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [3,3]
C0205412

Ähnliche Modelle

Eligibility Juvenile Idiopathic Arthritis NCT01727986

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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