ID

36509

Description

Comparison Study of PF530 and Betaferon in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02474134

Link

https://clinicaltrials.gov/show/NCT02474134

Keywords

Versions (1)
  1. 5/18/19 5/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02474134

English

Eligibility Multiple Sclerosis NCT02474134

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
Description

Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence | Childbearing Potential Partner Male sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0024559
males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
Description

Gender Vasectomy | Gender Sexual Abstinence | Gender Use of Condom | Gender Avoidance Sperm

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0042387
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0009653
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0870186
UMLS CUI [4,3]
C0037868
participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory assessments.
Description

Disease Free Medical History | Disease Free History of surgical procedures | Disease Free Physical Examination | Disease Free 12 lead ECG | Disease Free Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0489540
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332296
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332296
UMLS CUI [4,3]
C0430456
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
UMLS CUI [5,3]
C0022885
able to understand and sign the written informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female subjects who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the principal investigator.
Description

Cardiovascular Disease | Liver disease | Kidney Disease | Lung disease | Hematological Disease | Gastrointestinal Disease | Endocrine System Disease | Immune System Disease | Dermatologic disorder | Nervous system disorder | Metabolic Diseases | Psychological disease | Musculoskeletal Disease | Malignant Neoplasms | Exception Clinical Significance Absent

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0021053
UMLS CUI [9]
C0037274
UMLS CUI [10]
C0027765
UMLS CUI [11]
C0025517
UMLS CUI [12]
C1658764
UMLS CUI [13]
C0026857
UMLS CUI [14]
C0006826
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C2826293
UMLS CUI [15,3]
C0332197
previous treatment with any interferon product, including investigational use.
Description

Interferon | Interferon Use Investigational

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0457083
UMLS CUI [2,3]
C1517586
participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
Description

Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms | Exception Complete excision Basal cell carcinoma | Exception Complete excision Squamous cell carcinoma of skin | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0280100
UMLS CUI [3]
C0376545
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015250
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015250
UMLS CUI [5,3]
C0553723
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007117
UMLS CUI [6,3]
C1880198
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0553723
UMLS CUI [7,3]
C1880198
positive screening test for human immunodeficiency virus (hiv).
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
positive screening test for hepatitis c antibody (hcv ab) or current hepatitis b infection (defined as positive for hepatitis surface antigen [hbsag] at screening). participants with immunity to hepatitis b (defined as negative hbsag and positive hepatitis b surface antibody [hbsab]) are eligible to participate in the study.
Description

Hepatitis C antibody test positive | Hepatitis B | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C1277805
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0149709
history of epilepsy, seizure disorder or any unexplained black-outs.
Description

Epilepsy | Blackout Unexplained

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0312422
UMLS CUI [2,2]
C4288071
history of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (nsaid) that would preclude the use of at least 1 of these during the study.
Description

Allergy to acetaminophen | Intolerance to Acetaminophen | Allergy to nonsteroidal anti-inflammatory agents | Intolerance to Non-Steroidal Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1]
C0570513
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0000970
UMLS CUI [3]
C0746949
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003211
history of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
Description

Severe allergic reaction | Anaphylaxis Severe | Hypersensitivity Interferon beta-1b Component

Data type

boolean

Alias
UMLS CUI [1]
C2220378
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0244713
UMLS CUI [3,3]
C1705248
history of drug or alcohol abuse less than or equal to 12 months prior to screening.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
history of tobacco use less than or equal to 6 months prior to screening.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
a positive test for drugs of abuse or alcohol during screening or prior to dosing.
Description

Presence of drugs of abuse | Blood alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0428264
UMLS CUI [2]
C0948726
unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
Description

Alcohol Abstinence Unwilling | Alcohol Abstinence Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0678274
UMLS CUI [2,2]
C1299582
use of any prescription medication, over-the-counter medication, or herbal supplements/products during screening or throughout study, unless approved by both the principal investigator and the sponsor.
Description

Medication use During Screening | Use of Non-Prescription Drugs During Screening | Use of Herbal Supplements During Screening | Use of Herbal product During Screening | Medication use During Clinical Trial | Use of Non-Prescription Drugs During Clinical Trial | Use of Herbal Supplements During Clinical Trial | Use of Herbal product During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0013231
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0220908
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C1504473
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0220908
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C2240391
UMLS CUI [4,3]
C0347984
UMLS CUI [4,4]
C0220908
UMLS CUI [5,1]
C0240320
UMLS CUI [5,2]
C0347984
UMLS CUI [5,3]
C0008976
UMLS CUI [6,1]
C1524063
UMLS CUI [6,2]
C0013231
UMLS CUI [6,3]
C0347984
UMLS CUI [6,4]
C0008976
UMLS CUI [7,1]
C1524063
UMLS CUI [7,2]
C1504473
UMLS CUI [7,3]
C0347984
UMLS CUI [7,4]
C0008976
UMLS CUI [8,1]
C1524063
UMLS CUI [8,2]
C2240391
UMLS CUI [8,3]
C0347984
UMLS CUI [8,4]
C0008976
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Similar models

Eligibility Multiple Sclerosis NCT02474134

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence | Childbearing Potential Partner Male sterilization
Item
females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0024559 (UMLS CUI [3,3])
Gender Vasectomy | Gender Sexual Abstinence | Gender Use of Condom | Gender Avoidance Sperm
Item
males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
boolean
C0079399 (UMLS CUI [1,1])
C0042387 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0009653 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0870186 (UMLS CUI [4,2])
C0037868 (UMLS CUI [4,3])
Disease Free Medical History | Disease Free History of surgical procedures | Disease Free Physical Examination | Disease Free 12 lead ECG | Disease Free Laboratory Procedures
Item
participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ecg) and clinical laboratory assessments.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0489540 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
C0430456 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0022885 (UMLS CUI [5,3])
Informed Consent
Item
able to understand and sign the written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease | Liver disease | Kidney Disease | Lung disease | Hematological Disease | Gastrointestinal Disease | Endocrine System Disease | Immune System Disease | Dermatologic disorder | Nervous system disorder | Metabolic Diseases | Psychological disease | Musculoskeletal Disease | Malignant Neoplasms | Exception Clinical Significance Absent
Item
history of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the principal investigator.
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0021053 (UMLS CUI [8])
C0037274 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
C1658764 (UMLS CUI [12])
C0026857 (UMLS CUI [13])
C0006826 (UMLS CUI [14])
C1705847 (UMLS CUI [15,1])
C2826293 (UMLS CUI [15,2])
C0332197 (UMLS CUI [15,3])
Interferon | Interferon Use Investigational
Item
previous treatment with any interferon product, including investigational use.
boolean
C3652465 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0457083 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Malignant Neoplasms | Solid Neoplasm | Hematologic Neoplasms | Exception Complete excision Basal cell carcinoma | Exception Complete excision Squamous cell carcinoma of skin | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured
Item
participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
boolean
C0006826 (UMLS CUI [1])
C0280100 (UMLS CUI [2])
C0376545 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0015250 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0007117 (UMLS CUI [6,2])
C1880198 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0553723 (UMLS CUI [7,2])
C1880198 (UMLS CUI [7,3])
HIV Seropositivity
Item
positive screening test for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
Hepatitis C antibody test positive | Hepatitis B | Hepatitis B surface antigen positive
Item
positive screening test for hepatitis c antibody (hcv ab) or current hepatitis b infection (defined as positive for hepatitis surface antigen [hbsag] at screening). participants with immunity to hepatitis b (defined as negative hbsag and positive hepatitis b surface antibody [hbsab]) are eligible to participate in the study.
boolean
C1277805 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Epilepsy | Blackout Unexplained
Item
history of epilepsy, seizure disorder or any unexplained black-outs.
boolean
C0014544 (UMLS CUI [1])
C0312422 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
Allergy to acetaminophen | Intolerance to Acetaminophen | Allergy to nonsteroidal anti-inflammatory agents | Intolerance to Non-Steroidal Anti-Inflammatory Agents
Item
history of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (nsaid) that would preclude the use of at least 1 of these during the study.
boolean
C0570513 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
C0746949 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0003211 (UMLS CUI [4,2])
Severe allergic reaction | Anaphylaxis Severe | Hypersensitivity Interferon beta-1b Component
Item
history of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0244713 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Substance Use Disorders
Item
history of drug or alcohol abuse less than or equal to 12 months prior to screening.
boolean
C0038586 (UMLS CUI [1])
Tobacco use
Item
history of tobacco use less than or equal to 6 months prior to screening.
boolean
C0543414 (UMLS CUI [1])
Presence of drugs of abuse | Blood alcohol test positive
Item
a positive test for drugs of abuse or alcohol during screening or prior to dosing.
boolean
C0428264 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Alcohol Abstinence Unwilling | Alcohol Abstinence Unable
Item
unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0678274 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medication use During Screening | Use of Non-Prescription Drugs During Screening | Use of Herbal Supplements During Screening | Use of Herbal product During Screening | Medication use During Clinical Trial | Use of Non-Prescription Drugs During Clinical Trial | Use of Herbal Supplements During Clinical Trial | Use of Herbal product During Clinical Trial
Item
use of any prescription medication, over-the-counter medication, or herbal supplements/products during screening or throughout study, unless approved by both the principal investigator and the sponsor.
boolean
C0240320 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0220908 (UMLS CUI [2,4])
C1524063 (UMLS CUI [3,1])
C1504473 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0220908 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C2240391 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C0220908 (UMLS CUI [4,4])
C0240320 (UMLS CUI [5,1])
C0347984 (UMLS CUI [5,2])
C0008976 (UMLS CUI [5,3])
C1524063 (UMLS CUI [6,1])
C0013231 (UMLS CUI [6,2])
C0347984 (UMLS CUI [6,3])
C0008976 (UMLS CUI [6,4])
C1524063 (UMLS CUI [7,1])
C1504473 (UMLS CUI [7,2])
C0347984 (UMLS CUI [7,3])
C0008976 (UMLS CUI [7,4])
C1524063 (UMLS CUI [8,1])
C2240391 (UMLS CUI [8,2])
C0347984 (UMLS CUI [8,3])
C0008976 (UMLS CUI [8,4])
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