None listed
Conditions
Brief summary
To reduce the occurrence of autoimmune adverse events from the treatment of multiple sclerosis (MS) with alemtuzumab through the subsequent targeted use of rituximab. The hypothesis to be tested is that rituximab therapy following alemtuzumab treatment for MS will reduce the frequency of autoimmune adverse events. If this strategy proves to be safe and is effective in preventing or significantly reducing the frequency of autoimmune adverse events in the treatment of MS with alemtuzumab, then this approach could be adopted immediately in a large number of pwMS with an immediate reduction in co-morbidity.
Interventions
The investigational product is rituximab, which is a monoclonal antibody against CD20 that cause lysis of B-lymphocytes. The antibody is a humanised mouse antibody and is administered intravenously via an infusion over 30 minutes. The dosage to be used is 100 mg/m2 of estimated body surface area (BSA). BSA will be estimated based on height and weight according to the Du Bois formula.
Arm 1: Intervention
Arm 2: Placebo
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosed with relapsing remitting MS (RRMS) by a neurologist - Diagnosis of MS meeting 2017 McDonald criteria - Diagnosed with MS within the previous 10 years -Expanded disability status scale (EDSS)15 score < 5.0 -English speaking or non-English speaking who can ensure external interpreter assistance (e.g. relative or friend) to attend all visits for the duration of the clinical trial. -Available to attend clinic visits -Willing to sign up for and comply with Bloodwatch monitoring program
Exclusion criteria
-Known or suspected prior autoimmune disease (other than MS) -Any other serious co-morbidity that in the view of the investigator would preclude participation in the study - Pregnant (if female) - Currently lactating (if female) -Unwilling or unable to use appropriate contraception for the treatment phase of the study (2 years) – male or female -Recent or current history of major depression, bipolar disorder, psychosis or suicidality -Currently or recently taking any illicit substances (including any cannabis product) -Allergy to valaciclovir -Allergy to Bactrim, Trimethoprim or Sulphur based antibiotics
Outcome results
None listed