Age
Item
male and female subjects between 18 to 65 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking
Item
female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Clinically isolated syndrome | Multiple sclerosis relapse
Item
subjects diagnosed with cis or rms according to the revised mcdonald criteria (2010)
boolean
C2921627 (UMLS CUI [1])
C0856120 (UMLS CUI [2])
Therapy naive | Rebif Injectable Product Dose multiple | Other Coding
Item
treatment-naive subjects or subjects treated with rebif® multi-dose injected by rebismart™ for no longer than 6 weeks prior to baseline visit
boolean
C0919936 (UMLS CUI [1])
C3232239 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
Injection Self Injector | Other Coding
Item
subjects that are able to self-inject with rebismart™ (in the opinion of the physician)
boolean
C1533685 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0181342 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
EDSS
Item
subjects with expanded disability status scale (edss) score less than (<) 6 (inclusive) at baseline
boolean
C0451246 (UMLS CUI [1])
Informed Consent | Data Collection Consent Form
Item
signed informed consent and subject data collection form
boolean
C0021430 (UMLS CUI [1])
C0010995 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
Relapse
Item
subjects experiencing a relapse within 30 days before baseline
boolean
C0035020 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in other studies within 30 days before baseline
boolean
C2348568 (UMLS CUI [1])
Therapy Multiple Sclerosis | Biological Response Modifiers | Immunomodulators | Immunosuppressive Agents | Combined Modality Therapy | Exception Rebif Dose multiple
Item
received any ms therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of rebif® multi-dose injected by rebismart™
boolean
C0087111 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C3232239 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0439064 (UMLS CUI [6,4])
Visual Impairment Excludes Injection Self | Physical impairment Excludes Injection Self
Item
any visual or physical impairment that precludes the subject from self-injecting the treatment using the rebismart™
boolean
C3665347 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1533685 (UMLS CUI [1,3])
C0036588 (UMLS CUI [1,4])
C0231171 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1533685 (UMLS CUI [2,3])
C0036588 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy and breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease Serious | Heart Disease | Cardiac Arrhythmia Uncontrolled | Angina Pectoris Uncontrolled | Cardiomyopathy | Congestive heart failure Uncontrolled
Item
serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Substance Use Disorders
Item
current or past (within the last 2 years) history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Medical contraindication Interferon beta-1a
Item
have any contra-indications to treatment with interferon beta-1a according to summary of product characteristics
boolean
C1301624 (UMLS CUI [1,1])
C0254119 (UMLS CUI [1,2])