ID

32336

Beskrivning

Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00647348

Länk

https://clinicaltrials.gov/show/NCT00647348

Nyckelord

Versioner (1)
  1. 2018-10-27 2018-10-27 -
Rättsinnehavare

See clinicaltrials.gov

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27 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Secondary Progressive Multiple Sclerosis NCT00647348

Engelsk

Eligibility Secondary Progressive Multiple Sclerosis NCT00647348

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. progression can be evident from either an increase of at least one point on the edss or clinical documentation of increasing disability.
Beskrivning

Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Disease Progression Steady | Etiology Disability Increasing | EDSS point Increase

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0751965
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0205361
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0231170
UMLS CUI [4,3]
C0442808
UMLS CUI [5,1]
C0451246
UMLS CUI [5,2]
C1552961
UMLS CUI [5,3]
C0442805
edss 4.0 - 6.5 inclusive
Beskrivning

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
Beskrivning

Childbearing Potential Contraceptive methods | Avoidance Teratogenic effects Simvastatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0232910
UMLS CUI [2,3]
C0074554
able to give written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
18 - 65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to give informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
primary progressive ms
Beskrivning

Multiple Sclerosis, Primary Progressive

Datatyp

boolean

Alias
UMLS CUI [1]
C0751964
those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. these patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period.
Beskrivning

Relapse | Intravenous steroid injection | Oral steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2]
C0563322
UMLS CUI [3]
C0574135
patient is already taking or is anticipated to be taking a statin.
Beskrivning

Statin | Statin Anticipated

Datatyp

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C3840775
any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
Beskrivning

Pharmaceutical Preparations Interaction Statins | Fibrates | Nicotinic Acid | Cyclosporine | Azole antifungal | Macrolide Antibiotics | Protease Inhibitors | nefazodone | Verapamil | Amiodarone | GRAPEFRUIT JUICE Large amount | Alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0360714
UMLS CUI [2]
C1449704
UMLS CUI [3]
C0028049
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0360363
UMLS CUI [6]
C0003240
UMLS CUI [7]
C0033607
UMLS CUI [8]
C0068485
UMLS CUI [9]
C0042523
UMLS CUI [10]
C0002598
UMLS CUI [11,1]
C0452456
UMLS CUI [11,2]
C3869890
UMLS CUI [12]
C0085762
the use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
Beskrivning

Immunosuppressive Agents | Azathioprine | Methotrexate | Cyclosporine | Disease Modification Treatment | Avonex | Rebif | Betaferon | Glatiramer

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0010592
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C3840684
UMLS CUI [5,3]
C0087111
UMLS CUI [6]
C0594372
UMLS CUI [7]
C0752980
UMLS CUI [8]
C0592527
UMLS CUI [9]
C0717787
the use of mitoxantrone if treated within the last 12 months.
Beskrivning

Mitoxantrone

Datatyp

boolean

Alias
UMLS CUI [1]
C0026259
if the patient has ever been treated with alemtuzumab.
Beskrivning

alemtuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0383429
if screening levels of alanine aminotransferase (alt), aspartate aminotransferase (ast) or creatine kinase (ck) are three times the upper limit of normal patients should be excluded.
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated creatine kinase

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151576
patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
Beskrivning

Baseline Scan Receive Unable | Scan Inadequate Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C0441633
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0441633
UMLS CUI [2,2]
C0205412
UMLS CUI [2,3]
C0936012
if a female patient is pregnant or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Secondary Progressive Multiple Sclerosis NCT00647348

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Disease Progression Steady | Etiology Disability Increasing | EDSS point Increase
Item
patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. progression can be evident from either an increase of at least one point on the edss or clinical documentation of increasing disability.
boolean
C0026769 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0205361 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0231170 (UMLS CUI [4,2])
C0442808 (UMLS CUI [4,3])
C0451246 (UMLS CUI [5,1])
C1552961 (UMLS CUI [5,2])
C0442805 (UMLS CUI [5,3])
EDSS
Item
edss 4.0 - 6.5 inclusive
boolean
C0451246 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Avoidance Teratogenic effects Simvastatin
Item
women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0232910 (UMLS CUI [2,2])
C0074554 (UMLS CUI [2,3])
Informed Consent
Item
able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
18 - 65 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive
Item
primary progressive ms
boolean
C0751964 (UMLS CUI [1])
Relapse | Intravenous steroid injection | Oral steroid therapy
Item
those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. these patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period.
boolean
C0035020 (UMLS CUI [1])
C0563322 (UMLS CUI [2])
C0574135 (UMLS CUI [3])
Statin | Statin Anticipated
Item
patient is already taking or is anticipated to be taking a statin.
boolean
C0360714 (UMLS CUI [1])
C0360714 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Pharmaceutical Preparations Interaction Statins | Fibrates | Nicotinic Acid | Cyclosporine | Azole antifungal | Macrolide Antibiotics | Protease Inhibitors | nefazodone | Verapamil | Amiodarone | GRAPEFRUIT JUICE Large amount | Alcohol abuse
Item
any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0360714 (UMLS CUI [1,3])
C1449704 (UMLS CUI [2])
C0028049 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0360363 (UMLS CUI [5])
C0003240 (UMLS CUI [6])
C0033607 (UMLS CUI [7])
C0068485 (UMLS CUI [8])
C0042523 (UMLS CUI [9])
C0002598 (UMLS CUI [10])
C0452456 (UMLS CUI [11,1])
C3869890 (UMLS CUI [11,2])
C0085762 (UMLS CUI [12])
Immunosuppressive Agents | Azathioprine | Methotrexate | Cyclosporine | Disease Modification Treatment | Avonex | Rebif | Betaferon | Glatiramer
Item
the use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
boolean
C0021081 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C3840684 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C0594372 (UMLS CUI [6])
C0752980 (UMLS CUI [7])
C0592527 (UMLS CUI [8])
C0717787 (UMLS CUI [9])
Mitoxantrone
Item
the use of mitoxantrone if treated within the last 12 months.
boolean
C0026259 (UMLS CUI [1])
alemtuzumab
Item
if the patient has ever been treated with alemtuzumab.
boolean
C0383429 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated creatine kinase
Item
if screening levels of alanine aminotransferase (alt), aspartate aminotransferase (ast) or creatine kinase (ck) are three times the upper limit of normal patients should be excluded.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
Baseline Scan Receive Unable | Scan Inadequate Analysis
Item
patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
boolean
C1442488 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0441633 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0936012 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
if a female patient is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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