ID

40516

Beschreibung

A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study; ODM derived from: https://clinicaltrials.gov/show/NCT01673919

Link

https://clinicaltrials.gov/show/NCT01673919

Stichworte

Versionen (1)
  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 NCT01673919

Englisch

Eligibility Juvenile Idiopathic Arthritis NCT01673919

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who completed visit 33 (week 104) of wa19977 study and who may benefit from study drug treatment according to the investigator's assessment
Beschreibung

Visit Specified Completed | Benefit Due to Investigational Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0949266
patients have to receive the first roactemra/actemra infusion in this study at the week 8 visit at the latest
Beschreibung

RoActemra Infusion Scheduled | Actemra Infusion Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272237
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C2740854
UMLS CUI [2,2]
C0574032
UMLS CUI [2,3]
C0205539
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
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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
any infections with contraindications to roactemra/actemra therapy according to investigator judgment
Beschreibung

Communicable Diseases Medical contraindication RoActemra | Communicable Diseases Medical contraindication Actemra

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C3272237
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C2740854
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
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Ähnliche Modelle

Eligibility Juvenile Idiopathic Arthritis NCT01673919

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