ID

31778

Descrição

A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a; ODM derived from: https://clinicaltrials.gov/show/NCT00771043

Link

https://clinicaltrials.gov/show/NCT00771043

Palavras-chave

Versões (1)
  1. 27/09/2018 27/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00771043

Inglês

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00771043

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of rrms.
Descrição

Multiple Sclerosis, Relapsing-Remitting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
patients with unilateral aon consistent with multiple sclerosis (ms).
Descrição

Optic Neuritis Unilateral Consistent with Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0029134
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0026769
treatment with intravenous methylprednisolone (ivmp) at 1gm daily for three days after the onset of aon, without a taper, and completed within 14 days of the aon symptom onset.
Descrição

Methylprednisolone Intravenous U/day | Status post Onset of Optic Neuritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025815
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0029134
age 18-55 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
expanded disability status scale (edss) 0 to 5.0.
Descrição

EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
understand and sign informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or presence of progressive multifocal leukoencephalopathy (pml).
Descrição

Leukoencephalopathy, Progressive Multifocal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023524
diagnosis of primary progressive multiple sclerosis (ppms) or secondary progressive multiple sclerosis (spms).
Descrição

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
immune-compromised in the judgment of the investigator.
Descrição

Immune system Impaired

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020962
UMLS CUI [1,2]
C0221099
history of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or sponsor, would preclude participation in the study.
Descrição

Illness Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
Descrição

Disorder of eye | Diabetes Mellitus | Macular degeneration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015397
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0024437
previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (on) with the most recent on symptom onset being less than 12 months ago.
Descrição

Optic Disc Edema Severe | Optic disc hemorrhage Severe | Optic Neuritis Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2930835
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0474362
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0029134
UMLS CUI [3,2]
C1265611
previous treatment with > 1 disease modifying therapy (dmt).
Descrição

Disease Modification Therapy Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1265611
previous treatment with investigational products for ms, immunosuppressant or cytotoxic therapy.
Descrição

Investigational New Drugs Multiple Sclerosis | Immunosuppressive Agents | Cytotoxic therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0026769
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0677881
previous treatment with tysabri®
Descrição

Tysabri

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1529600
women who are not postmenopausal, surgically sterile, or willing to practice contraception.
Descrição

Gender | Postmenopausal state Absent | Female Sterilization Absent | Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
women pregnant, breast feeding, or planning to become pregnant.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
involved with other study protocol simultaneously without prior approval.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
determined not suitable for study participation by investigator and/or sponsor.
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00771043

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
diagnosis of rrms.
boolean
C0751967 (UMLS CUI [1])
Optic Neuritis Unilateral Consistent with Multiple Sclerosis
Item
patients with unilateral aon consistent with multiple sclerosis (ms).
boolean
C0029134 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
Methylprednisolone Intravenous U/day | Status post Onset of Optic Neuritis
Item
treatment with intravenous methylprednisolone (ivmp) at 1gm daily for three days after the onset of aon, without a taper, and completed within 14 days of the aon symptom onset.
boolean
C0025815 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0029134 (UMLS CUI [2,3])
Age
Item
age 18-55 years.
boolean
C0001779 (UMLS CUI [1])
EDSS
Item
expanded disability status scale (edss) 0 to 5.0.
boolean
C0451246 (UMLS CUI [1])
Informed Consent
Item
understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Leukoencephalopathy, Progressive Multifocal
Item
history or presence of progressive multifocal leukoencephalopathy (pml).
boolean
C0023524 (UMLS CUI [1])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
diagnosis of primary progressive multiple sclerosis (ppms) or secondary progressive multiple sclerosis (spms).
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
Immune system Impaired
Item
immune-compromised in the judgment of the investigator.
boolean
C0020962 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
Illness Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded
Item
history of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or sponsor, would preclude participation in the study.
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Disorder of eye | Diabetes Mellitus | Macular degeneration
Item
concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
boolean
C0015397 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0024437 (UMLS CUI [3])
Optic Disc Edema Severe | Optic disc hemorrhage Severe | Optic Neuritis Quantity
Item
previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (on) with the most recent on symptom onset being less than 12 months ago.
boolean
C2930835 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0474362 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0029134 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Disease Modification Therapy Quantity
Item
previous treatment with > 1 disease modifying therapy (dmt).
boolean
C0012634 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Investigational New Drugs Multiple Sclerosis | Immunosuppressive Agents | Cytotoxic therapy
Item
previous treatment with investigational products for ms, immunosuppressant or cytotoxic therapy.
boolean
C0013230 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
Tysabri
Item
previous treatment with tysabri®
boolean
C1529600 (UMLS CUI [1])
Gender | Postmenopausal state Absent | Female Sterilization Absent | Contraceptive methods Unwilling
Item
women who are not postmenopausal, surgically sterile, or willing to practice contraception.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women pregnant, breast feeding, or planning to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
involved with other study protocol simultaneously without prior approval.
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
determined not suitable for study participation by investigator and/or sponsor.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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