ID

19148

Beschreibung

Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta; ODM derived from: https://clinicaltrials.gov/show/NCT00493116

Link

https://clinicaltrials.gov/show/NCT00493116

Stichworte

Versionen (1)
  1. 08.12.16 08.12.16 -
Hochgeladen am

8. Dezember 2016

DOI

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Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493116

Englisch

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493116

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
Beschreibung

Interferon beta-1a Duration | interferon beta-1b Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0254119
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0244713
UMLS CUI [2,2]
C0449238
relapsing-remitting multiple sclerosis according to poser or mcdonald criteria
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
edss score of 6 or less
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
nab titre >or equal to 20 via cpe assay or >or equal to 100 via mxa protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
Beschreibung

Neutralizing Antibodies titer measurement | Cytopathic effect Assay | Myxovirus Resistance Protein Assay | Interferon-beta Injection | Tests Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C0474643
UMLS CUI [2,1]
C0333467
UMLS CUI [2,2]
C1510438
UMLS CUI [3,1]
C0072378
UMLS CUI [3,2]
C1510438
UMLS CUI [4,1]
C0015980
UMLS CUI [4,2]
C1828121
UMLS CUI [5,1]
C0392366
UMLS CUI [5,2]
C1265611
reduced bioavailability (relative expression of mxa mrna/gapdh
Beschreibung

Biological Availability Reduced | Expression Relative Myxovirus Resistance Proteins | Expression Relative Messenger RNA Glyceraldehyde-3-phosphate dehydrogenase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005508
UMLS CUI [1,2]
C0392756
UMLS CUI [2,1]
C1171362
UMLS CUI [2,2]
C0205345
UMLS CUI [2,3]
C0072378
UMLS CUI [3,1]
C1171362
UMLS CUI [3,2]
C0205345
UMLS CUI [3,3]
C0035696
UMLS CUI [3,4]
C3536868
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe allergic or anaphylactic reaction to human albumin, to any interferon, methylprednisolone or to any other component of study drugs
Beschreibung

severe allergic reaction Albumin Human | severe allergic reaction Interferons | severe allergic reaction Methylprednisolone | severe allergic reaction Investigational New Drugs Component | anaphylaxis Severe Albumin Human | anaphylaxis Severe Interferons | anaphylaxis Severe Methylprednisolone | anaphylaxis Severe Investigational New Drugs Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2220378
UMLS CUI [1,2]
C0304925
UMLS CUI [2,1]
C2220378
UMLS CUI [2,2]
C0021747
UMLS CUI [3,1]
C2220378
UMLS CUI [3,2]
C0025815
UMLS CUI [4,1]
C2220378
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1705248
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0304925
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0021747
UMLS CUI [7,1]
C0002792
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0025815
UMLS CUI [8,1]
C0002792
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0013230
UMLS CUI [8,4]
C1705248
clinically significant systemic illness
Beschreibung

Systemic disease Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C2826293
history of poorly controlled hypertension, diabetes, or osteoporosis
Beschreibung

Poor hypertension control | Diabetes mellitus poor control | Osteoporosis Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0860161
UMLS CUI [3,1]
C0029456
UMLS CUI [3,2]
C3853134
history of uncontrolled seizures within 3 months of enrollment
Beschreibung

Seizures Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
history of depression or suicidal ideation within 3 months of enrollment
Beschreibung

Depressive disorder | Feeling suicidal

Datentyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0424000
serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
Beschreibung

local infection Serious | Abscess | Cellulitis | Sepsis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0000833
UMLS CUI [3]
C0007642
UMLS CUI [4]
C0243026
abnormal screening blood tests
Beschreibung

Blood test abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0854146
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Ähnliche Modelle

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00493116

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Interferon beta-1a Duration | interferon beta-1b Duration
Item
must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
boolean
C0254119 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0244713 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing-remitting multiple sclerosis according to poser or mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
edss score of 6 or less
boolean
C0451246 (UMLS CUI [1])
Neutralizing Antibodies titer measurement | Cytopathic effect Assay | Myxovirus Resistance Protein Assay | Interferon-beta Injection | Tests Quantity
Item
nab titre >or equal to 20 via cpe assay or >or equal to 100 via mxa protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
boolean
C0475463 (UMLS CUI [1,1])
C0474643 (UMLS CUI [1,2])
C0333467 (UMLS CUI [2,1])
C1510438 (UMLS CUI [2,2])
C0072378 (UMLS CUI [3,1])
C1510438 (UMLS CUI [3,2])
C0015980 (UMLS CUI [4,1])
C1828121 (UMLS CUI [4,2])
C0392366 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Biological Availability Reduced | Expression Relative Myxovirus Resistance Proteins | Expression Relative Messenger RNA Glyceraldehyde-3-phosphate dehydrogenase
Item
reduced bioavailability (relative expression of mxa mrna/gapdh
boolean
C0005508 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C1171362 (UMLS CUI [2,1])
C0205345 (UMLS CUI [2,2])
C0072378 (UMLS CUI [2,3])
C1171362 (UMLS CUI [3,1])
C0205345 (UMLS CUI [3,2])
C0035696 (UMLS CUI [3,3])
C3536868 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
severe allergic reaction Albumin Human | severe allergic reaction Interferons | severe allergic reaction Methylprednisolone | severe allergic reaction Investigational New Drugs Component | anaphylaxis Severe Albumin Human | anaphylaxis Severe Interferons | anaphylaxis Severe Methylprednisolone | anaphylaxis Severe Investigational New Drugs Component
Item
history of severe allergic or anaphylactic reaction to human albumin, to any interferon, methylprednisolone or to any other component of study drugs
boolean
C2220378 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C2220378 (UMLS CUI [2,1])
C0021747 (UMLS CUI [2,2])
C2220378 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
C2220378 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0304925 (UMLS CUI [5,3])
C0002792 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0021747 (UMLS CUI [6,3])
C0002792 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0025815 (UMLS CUI [7,3])
C0002792 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0013230 (UMLS CUI [8,3])
C1705248 (UMLS CUI [8,4])
Systemic disease Clinical Significance
Item
clinically significant systemic illness
boolean
C0442893 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Poor hypertension control | Diabetes mellitus poor control | Osteoporosis Poorly controlled
Item
history of poorly controlled hypertension, diabetes, or osteoporosis
boolean
C0421190 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0029456 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
Seizures Uncontrolled
Item
history of uncontrolled seizures within 3 months of enrollment
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Depressive disorder | Feeling suicidal
Item
history of depression or suicidal ideation within 3 months of enrollment
boolean
C0011581 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
local infection Serious | Abscess | Cellulitis | Sepsis
Item
serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
boolean
C1400591 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0000833 (UMLS CUI [2])
C0007642 (UMLS CUI [3])
C0243026 (UMLS CUI [4])
Blood test abnormal
Item
abnormal screening blood tests
boolean
C0854146 (UMLS CUI [1])
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