Inclusion criteria Fulfill
Item
to be eligible to participate in this study, candidates must meet all the following eligibility criteria atthe screening visit (v0)and at baseline (v1):
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Informed Consent | Authorization Use of Patient data
Item
ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
boolean
C0021430 (UMLS CUI [1])
C0680281 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C2707520 (UMLS CUI [2,3])
Multiple Sclerosis, Relapsing-Remitting | Biological Response Modifier Therapy Rejected
Item
patients with rrms (mcdonald criteria, 2010) who do not accept current injectable firstline dmts.
boolean
C0751967 (UMLS CUI [1])
C0005527 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
Age
Item
age between 18 and 50 years at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Onset of Multiple Sclerosis Recent
Item
ms onset within one year before enrolment
boolean
C0332162 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Gadolinium-Enhancing Lesion MRI scan brain
Item
≥ 1 gd+ lesions at a brain mri scan performed within three months beforeenrolment.
boolean
C1333400 (UMLS CUI [1,1])
C0412675 (UMLS CUI [1,2])
Biological Response Modifier Therapy Absent Multiple Sclerosis | Therapeutic immunosuppression Absent Multiple Sclerosis
Item
no previous disease modifying and/or immunosuppressive treatments for ms.
boolean
C0005527 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
EDSS | Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Gender Contraceptive methods
Item
must have a baseline edss between 0.0 and 5.0, inclusive. · women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
boolean
C0451246 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Exclusion Criteria Fulfill
Item
candidates will be excluded from study entry if any of the following exclusion criteria exists at screening or baseline/randomization visit:
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
primary progressive, secondary progressive, or progressive relapsing ms, as defined by lublin and reingold (lublin and reingold 1996)
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Biological Response Modifier Therapy Multiple Sclerosis | Therapeutic immunosuppression Multiple Sclerosis | T-Cell Vaccination | T-Cell Receptor Vaccination | Monoclonal Antibodies | Mitoxantrone | Cyclophosphamide
Item
previous disease modifying and/or immunosuppressive treatments for ms, including tcell or t-cell receptor vaccination, any therapeutic monoclonal antibody, mitoxantrone, cyclophosphamide
boolean
C0005527 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0039194 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0034790 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0003250 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
Fumaderm | dimethyl fumarate | Fumarates
Item
previous treatment with fumaderm®, dimethyl fumarate or other fumarates
boolean
C0633802 (UMLS CUI [1])
C0058218 (UMLS CUI [2])
C0016801 (UMLS CUI [3])
Malignant Neoplasms | Exception Complete excision Basal cell carcinoma
Item
history of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
Allergic Reaction Severe | Anaphylaxis Severe | Drug Allergy | Hypersensitivity Gadolinium
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.known allergy/hypersensitivity to gadolinium.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
Laboratory test result abnormal | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Kidney Diseases | Disease Major Study Subject Participation Status Excluded
Item
history of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the investigator would preclude participation in a clinical trial.
boolean
C0438215 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042075 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C0332196 (UMLS CUI [9,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Liver di seases Serious | Liver diseases | Kidney Diseases | Bone Marrow Dysfunction | Diabetic - poor control | Mental disorders Serious | Mental disorders Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0023895 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0421258 (UMLS CUI [10])
C0004936 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0004936 (UMLS CUI [12,1])
C0439801 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
HIV Seropositivity | Hepatitis C antibody positive | Hepatitis B surface antigen positive
Item
history of or positive test result at screening for human immunodeficiency virus (hiv).positive for hepatitis c antibody and/or positive for hepatitis b surface antigen (hbsag) at screening.
boolean
C0019699 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Substance Use Disorders
Item
history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to inclusion.
boolean
C0038586 (UMLS CUI [1])
Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking
Item
an ms relapse that has occurred within the 30 days prior to inclusion (screening) and/or the subject has not stabilized from a previous relapse prior to inclusion.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1293130 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])