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])
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])