ID

36524

Description

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT02398461

Link

https://clinicaltrials.gov/show/NCT02398461

Keywords

Versions (1)
  1. 5/20/19 5/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461

English

Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females (18-70 years of age; < 104 kg)
Description

Age | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
capable of giving informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
meet diagnostic criteria for ms, as defined by revised (2010) mcdonald criteria
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to ms preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the investigator
Description

Relapse | Neurologic Symptoms New Multiple Sclerosis | Neurologic Symptoms Worsening Multiple Sclerosis | Status post Neurological status Stable | Status post Neurological status Improving | Fever Absent | Communicable Disease Absent | Neurologic Examination

Data type

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2,1]
C0235031
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0026769
UMLS CUI [3,1]
C0235031
UMLS CUI [3,2]
C0332271
UMLS CUI [3,3]
C0026769
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0746866
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0746866
UMLS CUI [5,3]
C1272745
UMLS CUI [6,1]
C0015967
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C0027853
has at least one new, identifiable, measurable and active lesion on mri (gd+) meeting the criteria of the imaging charter.
Description

Measurable lesion New Quantity MRI gadolinium-enhanced

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0855566
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
certain specified co-morbidities (including pregnancy)
Description

Comorbidity Specified | Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0032961
taking certain proscribed medications
Description

Prescribed medication

Data type

boolean

Alias
UMLS CUI [1]
C2239117
a medical regimen that has changed in the month prior to screening
Description

Treatment regimen Changed

Data type

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0392747
inability to undergo requisite mri evaluations
Description

MRI Evaluation Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1299582
drug or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
any other reason for which, in the opinion of the investigator, the subject should not participate in the study.
Description

Factor Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
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Similar models

Eligibility Multiple Sclerosis, Acute Relapsing NCT02398461

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body Weight
Item
males or females (18-70 years of age; < 104 kg)
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Informed Consent
Item
capable of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis
Item
meet diagnostic criteria for ms, as defined by revised (2010) mcdonald criteria
boolean
C0026769 (UMLS CUI [1])
Relapse | Neurologic Symptoms New Multiple Sclerosis | Neurologic Symptoms Worsening Multiple Sclerosis | Status post Neurological status Stable | Status post Neurological status Improving | Fever Absent | Communicable Disease Absent | Neurologic Examination
Item
present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to ms preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the investigator
boolean
C0035020 (UMLS CUI [1])
C0235031 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0235031 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0746866 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0746866 (UMLS CUI [5,2])
C1272745 (UMLS CUI [5,3])
C0015967 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0027853 (UMLS CUI [8])
Measurable lesion New Quantity MRI gadolinium-enhanced
Item
has at least one new, identifiable, measurable and active lesion on mri (gd+) meeting the criteria of the imaging charter.
boolean
C1513041 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0855566 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Comorbidity Specified | Pregnancy
Item
certain specified co-morbidities (including pregnancy)
boolean
C0009488 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
Prescribed medication
Item
taking certain proscribed medications
boolean
C2239117 (UMLS CUI [1])
Treatment regimen Changed
Item
a medical regimen that has changed in the month prior to screening
boolean
C0040808 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
MRI Evaluation Receive Unable
Item
inability to undergo requisite mri evaluations
boolean
C0024485 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Factor Study Subject Participation Status Unfavorable
Item
any other reason for which, in the opinion of the investigator, the subject should not participate in the study.
boolean
C1521761 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
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