ID

37018

Descrizione

Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS); ODM derived from: https://clinicaltrials.gov/show/NCT02428218

collegamento

https://clinicaltrials.gov/show/NCT02428218

Keywords

versioni (1)
  1. 30/06/19 30/06/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

30 giugno 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

Inglese

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

1 moduli  
Criteria
Descrizione

Criteria

informed consent and assent as appropriate
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
must have a body weight of ≥30 kg
Descrizione

Body Weight

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005910
must have a diagnosis of rrms as defined by the revised consensus definition for pediatric multiple sclerosis (ms)
Descrizione

Multiple Sclerosis, Relapsing-Remitting

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0751967
must be ambulatory with a converted krutzke baseline expanded disability status scale (edss) score between 0 and 5.0, inclusive
Descrizione

Ambulatory | EDSS

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0439841
UMLS CUI [2]
C0451246
key exclusion criteria:
Descrizione

Exclusion Criteria Main

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
primary progressive, secondary progressive, or progressive relapsing ms.
Descrizione

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
history of disorders mimicking ms, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
Descrizione

Demyelinating Diseases | Encephalomyelitis, Acute Disseminated | Systemic autoimmune disease | Sjogren's Syndrome | Lupus Erythematosus | Metabolic Diseases | Dystrophy | Communicable Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011303
UMLS CUI [2]
C0014059
UMLS CUI [3]
C2895206
UMLS CUI [4]
C1527336
UMLS CUI [5]
C0409974
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0333606
UMLS CUI [8]
C0009450
history of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (dmf) or fumaric acid esters.
Descrizione

Allergic Reactions Severe | Anaphylaxis Severe | Hypersensitivity Dimethyl fumarate | Hypersensitivity Fumaric Acid Esters

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0058218
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1959568
prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
Descrizione

Mitoxantrone | Cyclophosphamide | rituximab

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0393022
prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (iv) immunoglobulin, plasmapheresis or cytapheresis.
Descrizione

fingolimod | teriflunomide | natalizumab | Cyclosporine | Azathioprine | Methotrexate | mycophenolate mofetil | laquinimod | Immunoglobulins, Intravenous | Plasmapheresis | Cytapheresis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1699926
UMLS CUI [2]
C1718383
UMLS CUI [3]
C1172734
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0025677
UMLS CUI [7]
C0209368
UMLS CUI [8]
C1260208
UMLS CUI [9]
C0085297
UMLS CUI [10]
C0032134
UMLS CUI [11]
C0079186
note: other protocol defined inclusion/exclusion criteria may apply.
Descrizione

Eligibility Criteria Study Protocol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Informed Consent
Item
informed consent and assent as appropriate
boolean
C0021430 (UMLS CUI [1])
Body Weight
Item
must have a body weight of ≥30 kg
boolean
C0005910 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
must have a diagnosis of rrms as defined by the revised consensus definition for pediatric multiple sclerosis (ms)
boolean
C0751967 (UMLS CUI [1])
Ambulatory | EDSS
Item
must be ambulatory with a converted krutzke baseline expanded disability status scale (edss) score between 0 and 5.0, inclusive
boolean
C0439841 (UMLS CUI [1])
C0451246 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Demyelinating Diseases | Encephalomyelitis, Acute Disseminated | Systemic autoimmune disease | Sjogren's Syndrome | Lupus Erythematosus | Metabolic Diseases | Dystrophy | Communicable Diseases
Item
history of disorders mimicking ms, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
boolean
C0011303 (UMLS CUI [1])
C0014059 (UMLS CUI [2])
C2895206 (UMLS CUI [3])
C1527336 (UMLS CUI [4])
C0409974 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0333606 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
Allergic Reactions Severe | Anaphylaxis Severe | Hypersensitivity Dimethyl fumarate | Hypersensitivity Fumaric Acid Esters
Item
history of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (dmf) or fumaric acid esters.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0058218 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1959568 (UMLS CUI [4,2])
Mitoxantrone | Cyclophosphamide | rituximab
Item
prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
boolean
C0026259 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
fingolimod | teriflunomide | natalizumab | Cyclosporine | Azathioprine | Methotrexate | mycophenolate mofetil | laquinimod | Immunoglobulins, Intravenous | Plasmapheresis | Cytapheresis
Item
prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (iv) immunoglobulin, plasmapheresis or cytapheresis.
boolean
C1699926 (UMLS CUI [1])
C1718383 (UMLS CUI [2])
C1172734 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0209368 (UMLS CUI [7])
C1260208 (UMLS CUI [8])
C0085297 (UMLS CUI [9])
C0032134 (UMLS CUI [10])
C0079186 (UMLS CUI [11])
Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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