Age
Item
is between the age of 18 and 55 years (both included)
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis
Item
relapsing-remitting ms according to poser criteria (cdms or lsdms) 22 or definite ms according to mcdonald criteria 23
boolean
C0751967 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Disability Kurtzke multiple sclerosis rating scale
Item
disability equivalent to an edss of 5.5 or less 21
boolean
C0231170 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Relapse Quantity
Item
clinical activity defined as at least one reported or documented relapse within the last year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Protocol Compliance | Treatment withdrawal
Item
patient must be prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits, even if the treatment has to be withdrawn
boolean
C0525058 (UMLS CUI [1])
C1701941 (UMLS CUI [2])
Symptoms Multiple Sclerosis Similar
Item
any condition that might give rise to similar symptoms as ms
boolean
C1457887 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
Immunomodulation Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | Steroid therapy Intravenous High dose Recurrent disease
Item
immunomodulatory or immunosuppressive treatment for ms prior to inclusion into the study (prior pulse steroid treatment for relapses is allowed)
boolean
C1963758 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0444956 (UMLS CUI [3,3])
C0277556 (UMLS CUI [3,4])
Glucocorticoids | Corticotropin
Item
treatment with glucocorticoids or acth later than one month prior to inclusion into the study, i.e. at the screening visit
boolean
C0017710 (UMLS CUI [1])
C0001655 (UMLS CUI [2])
Recurrent disease Onset of
Item
onset of a relapse within one month prior to inclusion into the study, i.e. at the screening visit
boolean
C0277556 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Major Depressive Disorder
Item
history of major depression
boolean
C1269683 (UMLS CUI [1])
Substance Dependence
Item
alcohol or drug dependency
boolean
C0038580 (UMLS CUI [1])
Heart failure | Cardiomyopathy | Cardiac Arrhythmia | Myocardial Ischemia Unstable New York Heart Association Classification | Myocardial Ischemia Advanced New York Heart Association Classification
Item
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv)
boolean
C0018801 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0151744 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
Hypertensive disease | Blood Pressure
Item
significant hypertension (bp > 180/110 mmhg)
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
Renal Insufficiency | Serum creatinine raised
Item
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Plasma total cholesterol level
Item
total plasma cholesterol < 3.5 mmol/l
boolean
C1272107 (UMLS CUI [1])
Illness Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
any medical illness requiring treatment with systemic corticosteroids
boolean
C0221423 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
Systemic disease Affecting Patient safety | Systemic disease Affecting Compliance behavior | Systemic disease Affecting Evaluation Disability
Item
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0442893 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0231170 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Childbearing Potential | Gender Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Sexual Abstinence
Item
women who are pregnant, breast-feeding or have the possibility for pregnancy during the study. to avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0036899 (UMLS CUI [7,2])