ID

30945

Beschreibung

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

Stichworte

Versionen (1)
  1. 05.07.18 05.07.18 -
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See clinicaltrials.gov

Hochgeladen am

5. Juli 2018

DOI

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Eligibility Multiple Sclerosis NCT00784836

Englisch

Eligibility Multiple Sclerosis NCT00784836

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

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

Multiple Sclerosis, Acute Relapsing

Datentyp

boolean

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

EDSS

Datentyp

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.
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

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

Exclusion Criteria

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

Severe allergic reaction | Anaphylaxis Severe

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

Hypersensitivity Avonex Component

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms

Datentyp

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.
Beschreibung

Epilepsy | Blackout Unexplained | Seizure

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Electrocardiogram abnormal

Datentyp

boolean

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

HIV Infection | HIV Seropositivity

Datentyp

boolean

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

Hepatitis C | Hepatitis C Virus Positive

Datentyp

boolean

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

Abnormal blood test

Datentyp

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.
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Datentyp

boolean

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

White Blood Cell Count procedure

Datentyp

boolean

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

Platelet Count measurement

Datentyp

boolean

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

Hemoglobin measurement | Gender

Datentyp

boolean

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

Serum creatinine raised

Datentyp

boolean

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

Elevated prothrombin time | Partial thromboplastin time increased

Datentyp

boolean

Alias
UMLS CUI [1]
C2674387
UMLS CUI [2]
C0240671
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00784836

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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