ID

37018

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02428218

Stichworte

Versionen (1)
  1. 30.06.19 30.06.19 -
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See clinicaltrials.gov

Hochgeladen am

30. Juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

Englisch

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

1 Formulare  
Criteria
Beschreibung

Criteria

informed consent and assent as appropriate
Beschreibung

Informed Consent

Datentyp

boolean

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

Body Weight

Datentyp

boolean

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

Multiple Sclerosis, Relapsing-Remitting

Datentyp

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
Beschreibung

Ambulatory | EDSS

Datentyp

boolean

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

Exclusion Criteria Main

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Mitoxantrone | Cyclophosphamide | rituximab

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Relapsing-Remitting Multiple Sclerosis NCT02428218

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