ID

36464

Beskrivning

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02201108

Länk

https://clinicaltrials.gov/show/NCT02201108

Nyckelord

Versioner (1)
  1. 2019-05-16 2019-05-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02201108

Engelsk

Eligibility Multiple Sclerosis NCT02201108

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with relapsing multiple sclerosis are eligible. patients should meet the criteria of ms based on mcdonald criteria 2010 and international pediatric multiple sclerosis study group (ipmssg) criteria for pediatric ms, version of 2012 (5) and have:
Beskrivning

Multiple sclerosis relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0856120
at least one relapse (or attack) in the 12 months preceding randomization or
Beskrivning

Relapse Recent Quantity | Attack Recent Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1304680
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C1265611
at least two relapses (or attack) in the 24 months preceding randomization.
Beskrivning

Relapse Quantity | Attack Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1304680
UMLS CUI [2,2]
C1265611
≤17 years of age and ≥10 years of age at randomization.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.
Beskrivning

Informed Consent | Informed Consent Patient Representative | Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
edss score > 5.5 at screening or randomization visits.
Beskrivning

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
relapse within 30 days prior to randomization.
Beskrivning

Relapse Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332185
treated with:
Beskrivning

Treatment Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
Beskrivning

glatiramer acetate | Interferons | dimethyl fumarate

Datatyp

boolean

Alias
UMLS CUI [1]
C0289884
UMLS CUI [2]
C0021747
UMLS CUI [3]
C0058218
fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
Beskrivning

fingolimod | Immunoglobulins, Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C1699926
UMLS CUI [2]
C0085297
natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization,
Beskrivning

natalizumab | Immunosuppressive Agents | Biological Response Modifiers | Cyclophosphamide | Azathioprine | Cyclosporine | Methotrexate | MYCOPHENOLATE

Datatyp

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0005525
UMLS CUI [4]
C0010583
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0025677
UMLS CUI [8]
C0883242
cladribine or mitoxantrone within 2 years prior to randomization.
Beskrivning

Cladribine | Mitoxantrone

Datatyp

boolean

Alias
UMLS CUI [1]
C0092801
UMLS CUI [2]
C0026259
treated with alemtuzumab at any time.
Beskrivning

alemtuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0383429
history of hiv infection.
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
contraindication for mri.
Beskrivning

Medical contraindication MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
pregnant or breast-feeding females or those who plan to become pregnant during the study.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).
Beskrivning

Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status | Considerations Additional

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
Tillbaka till toppen

Similar models

Eligibility Multiple Sclerosis NCT02201108

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple sclerosis relapse
Item
patients with relapsing multiple sclerosis are eligible. patients should meet the criteria of ms based on mcdonald criteria 2010 and international pediatric multiple sclerosis study group (ipmssg) criteria for pediatric ms, version of 2012 (5) and have:
boolean
C0856120 (UMLS CUI [1])
Relapse Recent Quantity | Attack Recent Quantity
Item
at least one relapse (or attack) in the 12 months preceding randomization or
boolean
C0035020 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1304680 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Relapse Quantity | Attack Quantity
Item
at least two relapses (or attack) in the 24 months preceding randomization.
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1304680 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Age
Item
≤17 years of age and ≥10 years of age at randomization.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative | Informed Consent Parent | Informed Consent Guardian
Item
signed informed consent/assent obtained from patient and patient's legal representative (parents or guardians) according to local regulations.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
EDSS
Item
edss score > 5.5 at screening or randomization visits.
boolean
C0451246 (UMLS CUI [1])
Relapse Recent
Item
relapse within 30 days prior to randomization.
boolean
C0035020 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Treatment Pharmaceutical Preparations
Item
treated with:
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
glatiramer acetate | Interferons | dimethyl fumarate
Item
glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
boolean
C0289884 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0058218 (UMLS CUI [3])
fingolimod | Immunoglobulins, Intravenous
Item
fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
boolean
C1699926 (UMLS CUI [1])
C0085297 (UMLS CUI [2])
natalizumab | Immunosuppressive Agents | Biological Response Modifiers | Cyclophosphamide | Azathioprine | Cyclosporine | Methotrexate | MYCOPHENOLATE
Item
natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization,
boolean
C1172734 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0005525 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
Cladribine | Mitoxantrone
Item
cladribine or mitoxantrone within 2 years prior to randomization.
boolean
C0092801 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
alemtuzumab
Item
treated with alemtuzumab at any time.
boolean
C0383429 (UMLS CUI [1])
HIV Infection
Item
history of hiv infection.
boolean
C0019693 (UMLS CUI [1])
Medical contraindication MRI
Item
contraindication for mri.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breast-feeding females or those who plan to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent
Item
female patients of child-bearing potential not using highly effective contraceptive method (contraception in both female and male is required).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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