ID

31773

Beskrivning

Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00390221

Länk

https://clinicaltrials.gov/show/NCT00390221

Nyckelord

Versioner (1)
  1. 2018-09-27 2018-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00390221

Engelsk

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00390221

1 Formulär  
Criteria
Beskrivning

Criteria

multiple sclerosis (ms) subjects who have a confirmed diagnosis of relapsing-remitting ms according to mcdonald criteria #1-4 and a baseline expanded disability status scale (edss) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria
Beskrivning

Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0751967
UMLS CUI [3]
C0451246
have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (mri) demonstrating lesion(s) consistent with ms , or
Beskrivning

Relapse Quantity | Lesion Consistent with Multiple Sclerosis | MRI Cranium

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0026769
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0037303
show evidence of gadolinium-enhancing lesions of the brain on an mri performed within the 6 weeks prior to randomization.
Beskrivning

Lesion of brain Nuclear magnetic resonance imaging gadolinium-enhanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221505
UMLS CUI [1,2]
C0855566
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
diagnosis of primary progressive, secondary progressive, or progressive relapsing ms
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
history of malignancy
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
history of severe allergic or anaphylactic reactions or known drug hypersensitivity
Beskrivning

Severe allergic reaction | Anaphylaxis Severe | Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C2220378
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0013182
history of abnormal laboratory results
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
history of human immunodeficiency virus (hiv) or other immunodeficient conditions
Beskrivning

HIV Infection | Immunodeficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0021051
history of drug or alcohol abuse within the 2 years prior to randomization
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization
Beskrivning

Multiple sclerosis relapse | Relapse Previous Without Stabilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C1293130
positive screening for active infection with hepatitis b virus or hepatitis c virus
Beskrivning

Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
Beskrivning

Varicella Zoster Virus Infection | Herpes zoster infection | Viral infection severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0586989
UMLS CUI [2]
C0019360
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205082
exposure to varicella zoster virus within 21 days before screening.
Beskrivning

Exposure to Varicella zoster virus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0042338
abnormal blood tests at screening; hemoglobin ≤9.0 g/dl, platelets ≤100 × 109/l, lymphocytes ≤1.0 × 109/l, neutrophils ≤1.5 × 109/l, alanine aminotransferase/serum glutamate pyruvate transaminase (alt/sgpt), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (ast/sgot), or gamma-glutamyl-transferase >2 times the upper limit of normal (uln) and serum creatinine >uln.
Beskrivning

Abnormal blood test | Hemoglobin measurement | Platelet Count measurement | Lymphocyte Count measurement | Neutrophil count | Alanine aminotransferase increased | Aspartate aminotransferase increased | Gamma-glutamyl transferase raised | Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0854146
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0200635
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0151905
UMLS CUI [7]
C0151904
UMLS CUI [8]
C0151662
UMLS CUI [9]
C0700225
note: other protocol defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

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

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00390221

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | EDSS
Item
multiple sclerosis (ms) subjects who have a confirmed diagnosis of relapsing-remitting ms according to mcdonald criteria #1-4 and a baseline expanded disability status scale (edss) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria
boolean
C0026769 (UMLS CUI [1])
C0751967 (UMLS CUI [2])
C0451246 (UMLS CUI [3])
Relapse Quantity | Lesion Consistent with Multiple Sclerosis | MRI Cranium
Item
have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (mri) demonstrating lesion(s) consistent with ms , or
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3,1])
C0037303 (UMLS CUI [3,2])
Lesion of brain Nuclear magnetic resonance imaging gadolinium-enhanced
Item
show evidence of gadolinium-enhancing lesions of the brain on an mri performed within the 6 weeks prior to randomization.
boolean
C0221505 (UMLS CUI [1,1])
C0855566 (UMLS CUI [1,2])
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
diagnosis of primary progressive, secondary progressive, or progressive relapsing ms
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Malignant Neoplasms
Item
history of malignancy
boolean
C0006826 (UMLS CUI [1])
Severe allergic reaction | Anaphylaxis Severe | Drug Allergy
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3])
Laboratory test result abnormal
Item
history of abnormal laboratory results
boolean
C0438215 (UMLS CUI [1])
HIV Infection | Immunodeficiency
Item
history of human immunodeficiency virus (hiv) or other immunodeficient conditions
boolean
C0019693 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Substance Use Disorders
Item
history of drug or alcohol abuse within the 2 years prior to randomization
boolean
C0038586 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Previous Without Stabilization
Item
an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C1293130 (UMLS CUI [2,4])
Hepatitis B positive | Hepatitis C positive
Item
positive screening for active infection with hepatitis b virus or hepatitis c virus
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Varicella Zoster Virus Infection | Herpes zoster infection | Viral infection severe
Item
varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
boolean
C0586989 (UMLS CUI [1])
C0019360 (UMLS CUI [2])
C0042769 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Exposure to Varicella zoster virus
Item
exposure to varicella zoster virus within 21 days before screening.
boolean
C0332157 (UMLS CUI [1,1])
C0042338 (UMLS CUI [1,2])
Abnormal blood test | Hemoglobin measurement | Platelet Count measurement | Lymphocyte Count measurement | Neutrophil count | Alanine aminotransferase increased | Aspartate aminotransferase increased | Gamma-glutamyl transferase raised | Serum creatinine raised
Item
abnormal blood tests at screening; hemoglobin ≤9.0 g/dl, platelets ≤100 × 109/l, lymphocytes ≤1.0 × 109/l, neutrophils ≤1.5 × 109/l, alanine aminotransferase/serum glutamate pyruvate transaminase (alt/sgpt), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (ast/sgot), or gamma-glutamyl-transferase >2 times the upper limit of normal (uln) and serum creatinine >uln.
boolean
C0854146 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0200635 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
C0151904 (UMLS CUI [7])
C0151662 (UMLS CUI [8])
C0700225 (UMLS CUI [9])
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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