ID

19759

Descrizione

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Keywords

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  1. 27/01/17 27/01/17 -
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27 gennaio 2017

DOI

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Creative Commons BY-NC 3.0
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Eligibility Multiple Sclerosis Tysabri NCT00027300

Inglese

Admission Eligibility Multiple Sclerosis Tysabri NCT00027300

1 moduli  
Criteria for study participation.
Descrizione

Criteria for study participation.

Alias
UMLS CUI-1
C1512693
UMLS CUI-3
C1997894
Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
Descrizione

Multiple Sclerosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026769
between the ages of 18 and 50, inclusive
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
baseline edss score between 0.0 and 5.0, inclusive.
Descrizione

Baseline EDSS Score

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3830336
At least one MS-relapse within 12 month prior to randomization. Time since relapse should be measured from the time of relapse onset.
Descrizione

MS relapse

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0856120
cranial mri scan demonstrating lesion(s) consistent with MS.
Descrizione

Cranial mri scan

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0412674
UMLS CUI [1,2]
C0221198
Subject has given written informed consent to participate in the study.
Descrizione

written informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Medical History
Descrizione

Medical History

Alias
UMLS CUI-1
C0680251
UMLS CUI-3
C0262926
Subject has a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS defined by Lublin and Reingold (Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 month.
Descrizione

progressive relapsing MS

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0751964
UMLS CUI [1,2]
C0751965
UMLS CUI [1,3]
C0393666
MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse.
Descrizione

MS relapse

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0856120
Subject has had a clinically significant infectious illness within 30 days prior to randomization.
Descrizione

Communicable Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
Descrizione

abnormal laboratory results contraindicative for the administration of a recombinant humanized antibody

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C2985546
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
Descrizione

drug hypersensitivity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013182
Unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
Descrizione

unable to perform the timed 25-foot walk, 9hpt, and pasat 3.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3897356
UMLS CUI [2]
C0451335
UMLS CUI [3]
C0589060
abnormal blood tests performed at the screening visit.
Descrizione

abnormal blood tests

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0854146
Treatment History
Descrizione

Treatment History

Alias
UMLS CUI-1
C0680251
UMLS CUI-3
C2348563
Subject has history of treatment with either interferon-ß or glatiramer acetate for a total of 6 or more month.
Descrizione

Interferon beta or glatiramer acetate

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015980
UMLS CUI [1,2]
C0289884
Subject has had prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, natalizumab or any other therapeutic monoclonal antibody.
Descrizione

Prior treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024230
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0092801
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C0039194
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1172734
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0003250
Subject has had any treatment with any of the following medications within 1 year prior to randomization: Mitoxantrone or Cyclophosphamide
Descrizione

Prior treatment with Mitoxantrone or Cyclophosphamide

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0026259
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0010583
Subject has had treatment with any of the following medications or procedures within 6 month prior to randomization: cyclosporine, azathioprine, methotrexate, glatiramer acetate, interferonß-1b or INFß-1a, intravenous immunoglobulin (IVIG), plasmapheresis or cytapheresis.
Descrizione

Prior treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0010592
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0004482
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0025677
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0289884
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0244713
UMLS CUI [6,1]
C1514463
UMLS CUI [6,2]
C0763140
UMLS CUI [7,1]
C1514463
UMLS CUI [7,2]
C0085297
UMLS CUI [8,1]
C1514463
UMLS CUI [8,2]
C0032134
UMLS CUI [9,1]
C1514463
UMLS CUI [9,2]
C0079186
Subject has had treatment with any of the following medications within 50 days prior to randomization: intravenous corticosteroid treatment or oral corticosteroid treatment
Descrizione

Prior treatment with steroids

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0563322
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0574135
Miscellaneous
Descrizione

Miscellaneous

Alias
UMLS CUI-1
C0680251
UMLS CUI-3
C0205395
Subject has had a history of alcohol or drug abuse within 2 years prior to randomization.
Descrizione

Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
Subject is a female who is not postmenopausal for at least one year, surgically sterile, or willing to practice effective contraception during the study. The rhythm method is not to be used as the sole method of contraception.
Descrizione

Female of childbearing potential

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1960468
A nursing mother, pregnant woman, or woman planning to become pregnant while on study.
Descrizione

Pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
Subject has had previous participation in this study.
Descrizione

Previous participation in this study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
Subject has had participation in previous natalizumab studies (unless subject was on placebo.).*
Descrizione

Previous participation in natalizumab studies

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1172734
* If a subject was on placebo in a previous natalizumab study, please enter that study number and the subject ID from that study here.
Descrizione

*if subject was on placebo previously

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1172734
UMLS CUI [1,2]
C0032042
Subject is unwilling or is unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject´s ability to comply with the study protocol.
Descrizione

Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1321605
Subject is determined unsuitable for enrollment into this study for any other reason in the opinion of the Investigator and/or the Sponsor.
Descrizione

Exclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Admission Eligibility Multiple Sclerosis Tysabri NCT00027300

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Criteria for study participation.
C1512693 (UMLS CUI-1)
C1997894 (UMLS CUI-3)
Multiple Sclerosis
Item
Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
boolean
C0026769 (UMLS CUI [1])
Age
Item
between the ages of 18 and 50, inclusive
boolean
C0001779 (UMLS CUI [1])
Baseline EDSS Score
Item
baseline edss score between 0.0 and 5.0, inclusive.
boolean
C3830336 (UMLS CUI [1])
MS relapse
Item
At least one MS-relapse within 12 month prior to randomization. Time since relapse should be measured from the time of relapse onset.
boolean
C0856120 (UMLS CUI [1])
Cranial mri scan
Item
cranial mri scan demonstrating lesion(s) consistent with MS.
boolean
C0412674 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
written informed consent
Item
Subject has given written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
Medical History
C0680251 (UMLS CUI-1)
C0262926 (UMLS CUI-3)
progressive relapsing MS
Item
Subject has a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS defined by Lublin and Reingold (Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 month.
boolean
C0751964 (UMLS CUI [1,1])
C0751965 (UMLS CUI [1,2])
C0393666 (UMLS CUI [1,3])
MS relapse
Item
MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse.
boolean
C0856120 (UMLS CUI [1])
Communicable Disease
Item
Subject has had a clinically significant infectious illness within 30 days prior to randomization.
boolean
C0009450 (UMLS CUI [1])
abnormal laboratory results contraindicative for the administration of a recombinant humanized antibody
Item
history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
boolean
C1254595 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
drug hypersensitivity
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
Item
Unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
boolean
C3897356 (UMLS CUI [1])
C0451335 (UMLS CUI [2])
C0589060 (UMLS CUI [3])
abnormal blood tests
Item
abnormal blood tests performed at the screening visit.
boolean
C0854146 (UMLS CUI [1])
Item Group
Treatment History
C0680251 (UMLS CUI-1)
C2348563 (UMLS CUI-3)
Interferon beta or glatiramer acetate
Item
Subject has history of treatment with either interferon-ß or glatiramer acetate for a total of 6 or more month.
boolean
C0015980 (UMLS CUI [1,1])
C0289884 (UMLS CUI [1,2])
Prior treatment
Item
Subject has had prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, natalizumab or any other therapeutic monoclonal antibody.
boolean
C1514463 (UMLS CUI [1,1])
C0024230 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0092801 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0039194 (UMLS CUI [3,3])
C1514463 (UMLS CUI [4,1])
C1172734 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
Prior treatment with Mitoxantrone or Cyclophosphamide
Item
Subject has had any treatment with any of the following medications within 1 year prior to randomization: Mitoxantrone or Cyclophosphamide
boolean
C1514463 (UMLS CUI [1,1])
C0026259 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0010583 (UMLS CUI [2,2])
Prior treatment
Item
Subject has had treatment with any of the following medications or procedures within 6 month prior to randomization: cyclosporine, azathioprine, methotrexate, glatiramer acetate, interferonß-1b or INFß-1a, intravenous immunoglobulin (IVIG), plasmapheresis or cytapheresis.
boolean
C1514463 (UMLS CUI [1,1])
C0010592 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0004482 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0289884 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0244713 (UMLS CUI [5,2])
C1514463 (UMLS CUI [6,1])
C0763140 (UMLS CUI [6,2])
C1514463 (UMLS CUI [7,1])
C0085297 (UMLS CUI [7,2])
C1514463 (UMLS CUI [8,1])
C0032134 (UMLS CUI [8,2])
C1514463 (UMLS CUI [9,1])
C0079186 (UMLS CUI [9,2])
Prior treatment with steroids
Item
Subject has had treatment with any of the following medications within 50 days prior to randomization: intravenous corticosteroid treatment or oral corticosteroid treatment
boolean
C1514463 (UMLS CUI [1,1])
C0563322 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0574135 (UMLS CUI [2,2])
Item Group
Miscellaneous
C0680251 (UMLS CUI-1)
C0205395 (UMLS CUI-3)
Substance Use Disorders
Item
Subject has had a history of alcohol or drug abuse within 2 years prior to randomization.
boolean
C0038586 (UMLS CUI [1])
Female of childbearing potential
Item
Subject is a female who is not postmenopausal for at least one year, surgically sterile, or willing to practice effective contraception during the study. The rhythm method is not to be used as the sole method of contraception.
boolean
C1960468 (UMLS CUI [1])
Pregnancy
Item
A nursing mother, pregnant woman, or woman planning to become pregnant while on study.
boolean
C0032961 (UMLS CUI [1])
Previous participation in this study
Item
Subject has had previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
Previous participation in natalizumab studies
Item
Subject has had participation in previous natalizumab studies (unless subject was on placebo.).*
boolean
C2348568 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Item
* If a subject was on placebo in a previous natalizumab study, please enter that study number and the subject ID from that study here.
text
C1172734 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
*if subject was on placebo previously
Code List
* If a subject was on placebo in a previous natalizumab study, please enter that study number and the subject ID from that study here.
CL Item
Study No: (Study No:)
CL Item
Subject ID: (Subject ID:)
Compliance
Item
Subject is unwilling or is unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject´s ability to comply with the study protocol.
boolean
C1321605 (UMLS CUI [1])
Exclusion criteria
Item
Subject is determined unsuitable for enrollment into this study for any other reason in the opinion of the Investigator and/or the Sponsor.
boolean
C0680251 (UMLS CUI [1])
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