ID

30940

Description

A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State; ODM derived from: https://clinicaltrials.gov/show/NCT00744679

Link

https://clinicaltrials.gov/show/NCT00744679

Keywords

Versions (1)
  1. 7/5/18 7/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00744679

English

Eligibility Multiple Sclerosis NCT00744679

1 forms  
Criteria
Description

Criteria

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must be a multiple sclerosis (ms) patient enrolled in the tysabri outreach: united commitment to health prescribing program (touch) who is not expected to discontinue tysabri therapy prior to completion of the requirements of this study.
Description

Multiple Sclerosis | Tysabri | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C1529600
UMLS CUI [3]
C0525058
must have been treated with monthly iv infusions of tysabri 300 mg for at least 12 months, with the 9 most recent doses having been administered at 28±7 day intervals.
Description

Tysabri Intravenous infusions Monthly

Data type

boolean

Alias
UMLS CUI [1,1]
C1529600
UMLS CUI [1,2]
C0021440
UMLS CUI [1,3]
C0332177
must test negative for antibodies to tysabri at the screening visit.
Description

Antibody test negative Tysabri

Data type

boolean

Alias
UMLS CUI [1,1]
C1262044
UMLS CUI [1,2]
C1529600
must have a magnetic resonance imaging (mri) brain scan, performed prior to the initiation of treatment with tysabri, on file.
Description

MRI scan brain

Data type

boolean

Alias
UMLS CUI [1]
C0412675
must weigh between 42 and 126 kg, inclusive.
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
all male subjects and female subjects of childbearing potential must practice effective contraception during the study.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator.
Description

Laboratory test result abnormal | Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Gastrointestinal Diseases | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0021053
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0042075
UMLS CUI [9]
C0024115
UMLS CUI [10]
C0017178
UMLS CUI [11]
C0037274
UMLS CUI [12]
C0004936
UMLS CUI [13]
C0022658
UMLS CUI [14,1]
C0012634
UMLS CUI [14,2]
C0205164
positive result for antibodies to tysabri at any prior evaluation.
Description

Antibody test positive Tysabri

Data type

boolean

Alias
UMLS CUI [1,1]
C0741132
UMLS CUI [1,2]
C1529600
treatment with an investigational product or approved therapy for investigational use within 6 months prior to the start of pk sample collection or during the course of this study. concurrent participation in an observational study (e.g., tysabri global observational program in safety [tygris]) is permitted.
Description

Investigational New Drugs | Therapies, Investigational | Participation Observational Study allowed

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C1518527
UMLS CUI [3,3]
C0683607
pre-scheduled for any elective procedure or medical treatment during the study period.
Description

Elective procedure Scheduled | Therapeutic procedure Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0747973
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205539
history of drug or alcohol abuse (as defined by the investigator) within 2 years prior to the screening visit.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
female subjects who are breastfeeding, pregnant, or planning to become pregnant while on study.
Description

Breast Feeding | Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
alcohol use within 24 hours prior to the baseline visit.
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
inability or unwillingness to comply with study requirements, including the presence of any condition (e.g., physical, mental, social) that is likely to affect the subject's ability to comply with the study protocol.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling | Physical Condition Affecting Protocol Compliance | Mental condition Affecting Protocol Compliance | Social Condition Affecting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C3714565
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0037403
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0525058
other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
Description

Study Subject Participation Status Unsuitable for other reasons

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
note: other protocol defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Multiple Sclerosis NCT00744679

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
Multiple Sclerosis | Tysabri | Protocol Compliance
Item
must be a multiple sclerosis (ms) patient enrolled in the tysabri outreach: united commitment to health prescribing program (touch) who is not expected to discontinue tysabri therapy prior to completion of the requirements of this study.
boolean
C0026769 (UMLS CUI [1])
C1529600 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Tysabri Intravenous infusions Monthly
Item
must have been treated with monthly iv infusions of tysabri 300 mg for at least 12 months, with the 9 most recent doses having been administered at 28±7 day intervals.
boolean
C1529600 (UMLS CUI [1,1])
C0021440 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
Antibody test negative Tysabri
Item
must test negative for antibodies to tysabri at the screening visit.
boolean
C1262044 (UMLS CUI [1,1])
C1529600 (UMLS CUI [1,2])
MRI scan brain
Item
must have a magnetic resonance imaging (mri) brain scan, performed prior to the initiation of treatment with tysabri, on file.
boolean
C0412675 (UMLS CUI [1])
Body Weight
Item
must weigh between 42 and 126 kg, inclusive.
boolean
C0005910 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
all male subjects and female subjects of childbearing potential must practice effective contraception during the study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Laboratory test result abnormal | Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Gastrointestinal Diseases | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major
Item
history of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator.
boolean
C0438215 (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])
C0017178 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0004936 (UMLS CUI [12])
C0022658 (UMLS CUI [13])
C0012634 (UMLS CUI [14,1])
C0205164 (UMLS CUI [14,2])
Antibody test positive Tysabri
Item
positive result for antibodies to tysabri at any prior evaluation.
boolean
C0741132 (UMLS CUI [1,1])
C1529600 (UMLS CUI [1,2])
Investigational New Drugs | Therapies, Investigational | Participation Observational Study allowed
Item
treatment with an investigational product or approved therapy for investigational use within 6 months prior to the start of pk sample collection or during the course of this study. concurrent participation in an observational study (e.g., tysabri global observational program in safety [tygris]) is permitted.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0679823 (UMLS CUI [3,1])
C1518527 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Elective procedure Scheduled | Therapeutic procedure Scheduled
Item
pre-scheduled for any elective procedure or medical treatment during the study period.
boolean
C0747973 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Substance Use Disorders
Item
history of drug or alcohol abuse (as defined by the investigator) within 2 years prior to the screening visit.
boolean
C0038586 (UMLS CUI [1])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
female subjects who are breastfeeding, pregnant, or planning to become pregnant while on study.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Alcohol consumption
Item
alcohol use within 24 hours prior to the baseline visit.
boolean
C0001948 (UMLS CUI [1])
Protocol Compliance Unable | Protocol Compliance Unwilling | Physical Condition Affecting Protocol Compliance | Mental condition Affecting Protocol Compliance | Social Condition Affecting Protocol Compliance
Item
inability or unwillingness to comply with study requirements, including the presence of any condition (e.g., physical, mental, social) that is likely to affect the subject's ability to comply with the study protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C3714565 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0037403 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Study Subject Participation Status Unsuitable for other reasons
Item
other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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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