ID

30087

Beskrivning

Juvenile Idiopathic Arthritis (JIA) Registry; ODM derived from: https://clinicaltrials.gov/show/NCT00783510

Länk

https://clinicaltrials.gov/show/NCT00783510

Nyckelord

Versioner (2)
  1. 2018-05-09 2018-05-09 -
  2. 2018-05-09 2018-05-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT00783510

Engelsk

Eligibility Juvenile Idiopathic Arthritis NCT00783510

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
for a patient enrolling into the humira® arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course jia (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course jia) who has been prescribed humira® therapy according to the local approved humira® product labeling and meets one of the following criteria:
Beskrivning

Humira Arm | Patient Pediatric | Juvenile arthritis Polyarticular Moderate | Juvenile arthritis Course Polyarticular Moderate | Juvenile arthritis Polyarticular Severe | Juvenile arthritis Course Polyarticular Severe | Arthritis Affecting Joints Quantity | Humira prescribed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1171255
UMLS CUI [1,2]
C1522541
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1521725
UMLS CUI [3,1]
C3495559
UMLS CUI [3,2]
C0240789
UMLS CUI [3,3]
C0205081
UMLS CUI [4,1]
C3495559
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C0240789
UMLS CUI [4,4]
C0205081
UMLS CUI [5,1]
C3495559
UMLS CUI [5,2]
C0240789
UMLS CUI [5,3]
C0205082
UMLS CUI [6,1]
C3495559
UMLS CUI [6,2]
C0750729
UMLS CUI [6,3]
C0240789
UMLS CUI [6,4]
C0205082
UMLS CUI [7,1]
C0003864
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0022417
UMLS CUI [7,4]
C1265611
UMLS CUI [8,1]
C1171255
UMLS CUI [8,2]
C0278329
enrolled patients are 4 to 17 years of age as per approved humira® product label with the addition of jia patients 2 to < 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
newly initiated (within 24 months of registry entry) on humira® therapy and has received continuous (no more than 70 consecutive days off drug) humira® therapy, and the physician can provide available source documentation of saes, aes of special interest, and dosing information since initiation of therapy;
Beskrivning

Humira | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information

Datatyp

boolean

Alias
UMLS CUI [1]
C1171255
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0920316
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0920316
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C1533716
or is entering after participation (within 24 months of registry entry or, if longer, continuously treated at the same site) in an abbvie humira sponsored study, regardless of age or the number of joints with symptoms of jia, and has received continuous (no more than 70 consecutive days off drug) humira® therapy and the physician can provide available source documentation of saes, aes of special interest, and dosing information since initiation of therapy.
Beskrivning

Study Subject Participation Status | Humira Clinical Trial | Humira Continuous | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1171255
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C1171255
UMLS CUI [3,2]
C0549178
UMLS CUI [4,1]
C1519255
UMLS CUI [4,2]
C0920316
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0920316
UMLS CUI [6,1]
C0178602
UMLS CUI [6,2]
C1533716
for a patient enrolling into the mtx arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course jia (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course jia) who is prescribed mtx therapy alone or in combination with other disease modifying anti-rheumatic drugs (dmards) according to the local product labeling (initiated treatment within 24 months of registry entry) and has received continuous therapy and the physician can available provide source documentation of saes, aes of special interest, and dosing information since initiation of therapy.
Beskrivning

Methotrexate Arm | Patient Pediatric | Juvenile arthritis Polyarticular Moderate | Juvenile arthritis Course Polyarticular Moderate | Juvenile arthritis Polyarticular Severe | Juvenile arthritis Course Polyarticular Severe | Arthritis Affecting Joints Quantity | Methotrexate prescribed | Combined Modality Therapy | DMARD | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1522541
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1521725
UMLS CUI [3,1]
C3495559
UMLS CUI [3,2]
C0240789
UMLS CUI [3,3]
C0205081
UMLS CUI [4,1]
C3495559
UMLS CUI [4,2]
C0750729
UMLS CUI [4,3]
C0240789
UMLS CUI [4,4]
C0205081
UMLS CUI [5,1]
C3495559
UMLS CUI [5,2]
C0240789
UMLS CUI [5,3]
C0205082
UMLS CUI [6,1]
C3495559
UMLS CUI [6,2]
C0750729
UMLS CUI [6,3]
C0240789
UMLS CUI [6,4]
C0205082
UMLS CUI [7,1]
C0003864
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0022417
UMLS CUI [7,4]
C1265611
UMLS CUI [8,1]
C0025677
UMLS CUI [8,2]
C0278329
UMLS CUI [9]
C0009429
UMLS CUI [10]
C0242708
UMLS CUI [11,1]
C1519255
UMLS CUI [11,2]
C0920316
UMLS CUI [12,1]
C0877248
UMLS CUI [12,2]
C0920316
UMLS CUI [13,1]
C0178602
UMLS CUI [13,2]
C1533716
patients who were treated in the mtx arm of this registry and prematurely discontinued from the mtx arm due to being a non-responder, or became intolerant of mtx treatment or are in need of combination treatment with humira® therapy may be eligible to enroll into the humira® treatment arm if all ongoing aes/saes have been resolved, and they meet inclusion criteria and can enroll within the registry enrollment period. in case of ongoing aes/saes at the time of the treatment arm switch, the abbvie designated physician should be contacted to assess the eligibility of patient to roll into humira treatment arm.
Beskrivning

Patients Discontinued Methotrexate Arm | Disease Response Absent | Intolerance to Methotrexate | Difficulty Combined Modality Therapy Humira | Eligibility Humira Arm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0025677
UMLS CUI [1,4]
C1522541
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0025677
UMLS CUI [4,1]
C0332218
UMLS CUI [4,2]
C0009429
UMLS CUI [4,3]
C1171255
UMLS CUI [5,1]
C1548635
UMLS CUI [5,2]
C1171255
UMLS CUI [5,3]
C1522541
parent or guardian has voluntarily signed and dated an informed consent/patient authorization form, approved by an institutional review board (irb)/independent ethics committee (iec) if applicable according to local law, after the nature of the registry has been explained and the patient's parent or legal guardian has had the opportunity to ask questions. pediatric patients will be included in all discussions as per applicable local regulations in order to obtain verbal or written assent.
Beskrivning

Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients should not be enrolled into the humira® or methotrexate (mtx) arm if they cannot be prescribed and treated in accordance with the approved local humira® and/or with the local mtx product label
Beskrivning

Humira prescribing Unsuccessful | Methotrexate prescribing Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1171255
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0278329
UMLS CUI [2,3]
C1272705
patients should not be enrolled into the humira® or mtx arm if they require on-going treatment with kineret® (anakinra), orencia® (abatacept), rituxan® (rituximab), enbrel® (etanercept), and remicade® (infliximab), or any other approved biologic agents or investigational agents.
Beskrivning

Kineret | anakinra | Orencia | abatacept | Rituxan | rituximab | Enbrel | Etanercept | Remicade | infliximab | Biological Factors | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C1170364
UMLS CUI [2]
C0245109
UMLS CUI [3]
C1700021
UMLS CUI [4]
C1619966
UMLS CUI [5]
C0732355
UMLS CUI [6]
C0393022
UMLS CUI [7]
C0720193
UMLS CUI [8]
C0717758
UMLS CUI [9]
C0723012
UMLS CUI [10]
C0666743
UMLS CUI [11]
C0005515
UMLS CUI [12]
C0013230
patients should not be enrolled into the mtx arm if they have had prior treatment with any investigational agent or anti-rheumatic biologic therapy such as, but not limited to, orencia® (abatacept), enbrel® (etanercept), remicade® (infliximab), rituxan® (rituximab), or actemra® (tocilizumab)
Beskrivning

Exclusion Criteria Methotrexate Arm | Investigational New Drugs | Biological Therapy Antirheumatic | Orencia | abatacept | Enbrel | Etanercept | Remicade | infliximab | Rituxan | rituximab | Actemra | tocilizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0025677
UMLS CUI [1,3]
C1522541
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0005527
UMLS CUI [3,2]
C0003191
UMLS CUI [4]
C1700021
UMLS CUI [5]
C1619966
UMLS CUI [6]
C0720193
UMLS CUI [7]
C0717758
UMLS CUI [8]
C0723012
UMLS CUI [9]
C0666743
UMLS CUI [10]
C0732355
UMLS CUI [11]
C0393022
UMLS CUI [12]
C2740854
UMLS CUI [13]
C1609165
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Similar models

Eligibility Juvenile Idiopathic Arthritis NCT00783510

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Humira Arm | Patient Pediatric | Juvenile arthritis Polyarticular Moderate | Juvenile arthritis Course Polyarticular Moderate | Juvenile arthritis Polyarticular Severe | Juvenile arthritis Course Polyarticular Severe | Arthritis Affecting Joints Quantity | Humira prescribed
Item
for a patient enrolling into the humira® arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course jia (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course jia) who has been prescribed humira® therapy according to the local approved humira® product labeling and meets one of the following criteria:
boolean
C1171255 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1521725 (UMLS CUI [2,2])
C3495559 (UMLS CUI [3,1])
C0240789 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C3495559 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C0240789 (UMLS CUI [4,3])
C0205081 (UMLS CUI [4,4])
C3495559 (UMLS CUI [5,1])
C0240789 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
C3495559 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C0240789 (UMLS CUI [6,3])
C0205082 (UMLS CUI [6,4])
C0003864 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0022417 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
C1171255 (UMLS CUI [8,1])
C0278329 (UMLS CUI [8,2])
Age
Item
enrolled patients are 4 to 17 years of age as per approved humira® product label with the addition of jia patients 2 to < 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry.
boolean
C0001779 (UMLS CUI [1])
Humira | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information
Item
newly initiated (within 24 months of registry entry) on humira® therapy and has received continuous (no more than 70 consecutive days off drug) humira® therapy, and the physician can provide available source documentation of saes, aes of special interest, and dosing information since initiation of therapy;
boolean
C1171255 (UMLS CUI [1])
C1519255 (UMLS CUI [2,1])
C0920316 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0920316 (UMLS CUI [3,2])
C0178602 (UMLS CUI [4,1])
C1533716 (UMLS CUI [4,2])
Study Subject Participation Status | Humira Clinical Trial | Humira Continuous | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information
Item
or is entering after participation (within 24 months of registry entry or, if longer, continuously treated at the same site) in an abbvie humira sponsored study, regardless of age or the number of joints with symptoms of jia, and has received continuous (no more than 70 consecutive days off drug) humira® therapy and the physician can provide available source documentation of saes, aes of special interest, and dosing information since initiation of therapy.
boolean
C2348568 (UMLS CUI [1])
C1171255 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1171255 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C1519255 (UMLS CUI [4,1])
C0920316 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C0920316 (UMLS CUI [5,2])
C0178602 (UMLS CUI [6,1])
C1533716 (UMLS CUI [6,2])
Methotrexate Arm | Patient Pediatric | Juvenile arthritis Polyarticular Moderate | Juvenile arthritis Course Polyarticular Moderate | Juvenile arthritis Polyarticular Severe | Juvenile arthritis Course Polyarticular Severe | Arthritis Affecting Joints Quantity | Methotrexate prescribed | Combined Modality Therapy | DMARD | Serious Adverse Event Documentation | Adverse event Documentation | Dosage Information
Item
for a patient enrolling into the mtx arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course jia (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course jia) who is prescribed mtx therapy alone or in combination with other disease modifying anti-rheumatic drugs (dmards) according to the local product labeling (initiated treatment within 24 months of registry entry) and has received continuous therapy and the physician can available provide source documentation of saes, aes of special interest, and dosing information since initiation of therapy.
boolean
C0025677 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1521725 (UMLS CUI [2,2])
C3495559 (UMLS CUI [3,1])
C0240789 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C3495559 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C0240789 (UMLS CUI [4,3])
C0205081 (UMLS CUI [4,4])
C3495559 (UMLS CUI [5,1])
C0240789 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
C3495559 (UMLS CUI [6,1])
C0750729 (UMLS CUI [6,2])
C0240789 (UMLS CUI [6,3])
C0205082 (UMLS CUI [6,4])
C0003864 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0022417 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
C0025677 (UMLS CUI [8,1])
C0278329 (UMLS CUI [8,2])
C0009429 (UMLS CUI [9])
C0242708 (UMLS CUI [10])
C1519255 (UMLS CUI [11,1])
C0920316 (UMLS CUI [11,2])
C0877248 (UMLS CUI [12,1])
C0920316 (UMLS CUI [12,2])
C0178602 (UMLS CUI [13,1])
C1533716 (UMLS CUI [13,2])
Patients Discontinued Methotrexate Arm | Disease Response Absent | Intolerance to Methotrexate | Difficulty Combined Modality Therapy Humira | Eligibility Humira Arm
Item
patients who were treated in the mtx arm of this registry and prematurely discontinued from the mtx arm due to being a non-responder, or became intolerant of mtx treatment or are in need of combination treatment with humira® therapy may be eligible to enroll into the humira® treatment arm if all ongoing aes/saes have been resolved, and they meet inclusion criteria and can enroll within the registry enrollment period. in case of ongoing aes/saes at the time of the treatment arm switch, the abbvie designated physician should be contacted to assess the eligibility of patient to roll into humira treatment arm.
boolean
C0030705 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
C1704632 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C0332218 (UMLS CUI [4,1])
C0009429 (UMLS CUI [4,2])
C1171255 (UMLS CUI [4,3])
C1548635 (UMLS CUI [5,1])
C1171255 (UMLS CUI [5,2])
C1522541 (UMLS CUI [5,3])
Informed Consent Parent | Informed Consent Guardian
Item
parent or guardian has voluntarily signed and dated an informed consent/patient authorization form, approved by an institutional review board (irb)/independent ethics committee (iec) if applicable according to local law, after the nature of the registry has been explained and the patient's parent or legal guardian has had the opportunity to ask questions. pediatric patients will be included in all discussions as per applicable local regulations in order to obtain verbal or written assent.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Humira prescribing Unsuccessful | Methotrexate prescribing Unsuccessful
Item
patients should not be enrolled into the humira® or methotrexate (mtx) arm if they cannot be prescribed and treated in accordance with the approved local humira® and/or with the local mtx product label
boolean
C1171255 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Kineret | anakinra | Orencia | abatacept | Rituxan | rituximab | Enbrel | Etanercept | Remicade | infliximab | Biological Factors | Investigational New Drugs
Item
patients should not be enrolled into the humira® or mtx arm if they require on-going treatment with kineret® (anakinra), orencia® (abatacept), rituxan® (rituximab), enbrel® (etanercept), and remicade® (infliximab), or any other approved biologic agents or investigational agents.
boolean
C1170364 (UMLS CUI [1])
C0245109 (UMLS CUI [2])
C1700021 (UMLS CUI [3])
C1619966 (UMLS CUI [4])
C0732355 (UMLS CUI [5])
C0393022 (UMLS CUI [6])
C0720193 (UMLS CUI [7])
C0717758 (UMLS CUI [8])
C0723012 (UMLS CUI [9])
C0666743 (UMLS CUI [10])
C0005515 (UMLS CUI [11])
C0013230 (UMLS CUI [12])
Exclusion Criteria Methotrexate Arm | Investigational New Drugs | Biological Therapy Antirheumatic | Orencia | abatacept | Enbrel | Etanercept | Remicade | infliximab | Rituxan | rituximab | Actemra | tocilizumab
Item
patients should not be enrolled into the mtx arm if they have had prior treatment with any investigational agent or anti-rheumatic biologic therapy such as, but not limited to, orencia® (abatacept), enbrel® (etanercept), remicade® (infliximab), rituxan® (rituximab), or actemra® (tocilizumab)
boolean
C0680251 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C0005527 (UMLS CUI [3,1])
C0003191 (UMLS CUI [3,2])
C1700021 (UMLS CUI [4])
C1619966 (UMLS CUI [5])
C0720193 (UMLS CUI [6])
C0717758 (UMLS CUI [7])
C0723012 (UMLS CUI [8])
C0666743 (UMLS CUI [9])
C0732355 (UMLS CUI [10])
C0393022 (UMLS CUI [11])
C2740854 (UMLS CUI [12])
C1609165 (UMLS CUI [13])
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