ID

30945

Beschrijving

Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00784836

Link

https://clinicaltrials.gov/show/NCT00784836

Trefwoorden

Versies (1)
  1. 05-07-18 05-07-18 -
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See clinicaltrials.gov

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5 juli 2018

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Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00784836

Engels

Eligibility Multiple Sclerosis NCT00784836

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
must have a diagnosis of relapsing ms.
Beschrijving

Multiple Sclerosis, Acute Relapsing

Datatype

boolean

Alias
UMLS CUI [1]
C0393664
must have a screening expanded disability status scale (edss) score between 0 and 6.0, inclusive.
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
all male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of avonex.
Beschrijving

Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe allergic or anaphylactic reactions.
Beschrijving

Severe allergic reaction | Anaphylaxis Severe

Datatype

boolean

Alias
UMLS CUI [1]
C2220378
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
diagnosed with primary progressive, secondary progressive, or progressive relapsing ms.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
known allergy to any component of the avonex formulation.
Beschrijving

Hypersensitivity Avonex Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0594372
UMLS CUI [1,3]
C1705248
history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
Beschrijving

Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0042075
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0037274
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0022658
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0205164
subjects with history of malignant disease, including solid tumors and hematologic malignancies.
Beschrijving

Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0280100
UMLS CUI [3]
C0376545
history of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to day 1.
Beschrijving

Epilepsy | Blackout Unexplained | Seizure

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0039070
UMLS CUI [2,2]
C4288071
UMLS CUI [3]
C0036572
history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
Beschrijving

Feeling suicidal | Severe depression Episode | Severe depression Hospitalization Required | Initiation Antidepressant therapy | Antidepressant therapy Dose Increased

Datatype

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C0332189
UMLS CUI [3,1]
C0588008
UMLS CUI [3,2]
C1708385
UMLS CUI [4,1]
C1704686
UMLS CUI [4,2]
C1096649
UMLS CUI [5,1]
C1096649
UMLS CUI [5,2]
C1707810
clinically significant abnormal electrocardiogram (ecg) values as determined by the investigator.
Beschrijving

Electrocardiogram abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
known history of, or a positive test result for, human immunodeficiency virus (hiv).
Beschrijving

HIV Infection | HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019699
known history of, or a positive test result for hepatitis c virus.
Beschrijving

Hepatitis C | Hepatitis C Virus Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C4330254
abnormal screening blood tests exceeding any of the limits defined below:
Beschrijving

Abnormal blood test

Datatype

boolean

Alias
UMLS CUI [1]
C0854146
1. alanine transaminase/serum glutamate pyruvate transaminase (alt/sgpt) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
Beschrijving

Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0741494
2. total white blood cell count (wbc) <3700 cells/mm
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
3. platelet count <150,000 cells/mm
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
4. hemoglobin <10 g/dl in female subjects; <11 g/dl in male subjects
Beschrijving

Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
5. serum creatinine >upper limit of normal (uln)
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
6. prothrombin time (pt) or activated partial thromboplastin time (aptt) > 1.2*uln
Beschrijving

Elevated prothrombin time | Partial thromboplastin time increased

Datatype

boolean

Alias
UMLS CUI [1]
C2674387
UMLS CUI [2]
C0240671
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Similar models

Eligibility Multiple Sclerosis NCT00784836

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations.
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Acute Relapsing
Item
must have a diagnosis of relapsing ms.
boolean
C0393664 (UMLS CUI [1])
EDSS
Item
must have a screening expanded disability status scale (edss) score between 0 and 6.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
all male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of avonex.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Severe allergic reaction | Anaphylaxis Severe
Item
history of severe allergic or anaphylactic reactions.
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
diagnosed with primary progressive, secondary progressive, or progressive relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Hypersensitivity Avonex Component
Item
known allergy to any component of the avonex formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0594372 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major
Item
history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
boolean
C0018799 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042075 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0022658 (UMLS CUI [12])
C0012634 (UMLS CUI [13,1])
C0205164 (UMLS CUI [13,2])
Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms
Item
subjects with history of malignant disease, including solid tumors and hematologic malignancies.
boolean
C0006826 (UMLS CUI [1])
C0280100 (UMLS CUI [2])
C0376545 (UMLS CUI [3])
Epilepsy | Blackout Unexplained | Seizure
Item
history of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to day 1.
boolean
C0014544 (UMLS CUI [1])
C0039070 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3])
Feeling suicidal | Severe depression Episode | Severe depression Hospitalization Required | Initiation Antidepressant therapy | Antidepressant therapy Dose Increased
Item
history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
boolean
C0424000 (UMLS CUI [1])
C0588008 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0588008 (UMLS CUI [3,1])
C1708385 (UMLS CUI [3,2])
C1704686 (UMLS CUI [4,1])
C1096649 (UMLS CUI [4,2])
C1096649 (UMLS CUI [5,1])
C1707810 (UMLS CUI [5,2])
Electrocardiogram abnormal
Item
clinically significant abnormal electrocardiogram (ecg) values as determined by the investigator.
boolean
C0522055 (UMLS CUI [1])
HIV Infection | HIV Seropositivity
Item
known history of, or a positive test result for, human immunodeficiency virus (hiv).
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Hepatitis C | Hepatitis C Virus Positive
Item
known history of, or a positive test result for hepatitis c virus.
boolean
C0019196 (UMLS CUI [1])
C4330254 (UMLS CUI [2])
Abnormal blood test
Item
abnormal screening blood tests exceeding any of the limits defined below:
boolean
C0854146 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
1. alanine transaminase/serum glutamate pyruvate transaminase (alt/sgpt) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
White Blood Cell Count procedure
Item
2. total white blood cell count (wbc) <3700 cells/mm
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count <150,000 cells/mm
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
4. hemoglobin <10 g/dl in female subjects; <11 g/dl in male subjects
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum creatinine raised
Item
5. serum creatinine >upper limit of normal (uln)
boolean
C0700225 (UMLS CUI [1])
Elevated prothrombin time | Partial thromboplastin time increased
Item
6. prothrombin time (pt) or activated partial thromboplastin time (aptt) > 1.2*uln
boolean
C2674387 (UMLS CUI [1])
C0240671 (UMLS CUI [2])
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