Table 2.

Inclusion and exclusion criteria. All the inclusion criteria must be fulfilled. The presence of any of the exclusion criteria shall exclude the patient

Inclusion criteria	Exclusion criteria
MS according to most recent McDonald criteria	Previous use of immunosuppressive or cytostatic treatment, including mitoxantrone, cladribine, alemtuzumab or bone marrow transplantation or stem cell transplantation at any time prior to enrolment
Age 18–60 years	Treatment with fingolimod or natalizumab or dimethylfumarate in the past 12 weeks or teriflunomide within the past 15 weeks or ocrelizumab/rituximab within the past 6 months prior to the first administration
EDSS of 0–6.5 inclusive	Pregnancy or planning pregnancy in the next 12 months and breast feeding
First signs or symptoms at least 3 months prior to enrolment in the study	Drug or alcohol abuse
Active MS (relapsing and/or progressive): one relapse in the past year and/or at least one enhancing lesion on brain MRI in the past year; at least one new or enlarging T2 lesion in comparison with a reference scan from maximum 1 year before	Inability to undergo MRI assessments
Normal peripheral B-cell count after treatment with ocrelizumab
No evidence of relapse for at least 30 days prior to start of screening and throughout during the screening phase	History of or actual signs of immunodeficiency or malignancies
Positive T cell reactivity response to a mix of seven myelin-derived peptides	Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease
Able to sign informed consent and comply with the protocol assessments	Active or chronic infection (hepatitis B or C, HIV, syphilis or tuberculosis)
No wish to be treated with currently available DMT	Splenectomy
Appropriate venous access and *adequate cervical lymph nodes on ultrasound mapping
Use of adequate contraceptive measures. Women of childbearing potential can only be included in the study following use of adequate contraceptive measures. Accepted methods of contraception include use of hormonal contraceptives (oral, intravaginal, intrauterine or transdermal), intrauterine devices, sterilisation or postmenopausal status, use of condoms with spermicide.

*Only in TOLERVIT-MS.

DMT, disease-modifying treatments; EDSS, Expanded Disability Status Scale; MRI, Magnetic Resonance Imaging; MS, multiple sclerosis.