Clinical Trials

Reducing the frequency of Autoimmune adverse events in the treatment of Multiple sclerosis with alemtuzumab using B-celL dEpletion (RAMBLE): a phase II, randomised, placebo-controlled clinical trial

Type of Study/Intervention

Interventional

Recruitment Status

Recruiting

Form of MS

Relapsing Remitting MS

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.

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

Anticipated start date

01/01/2022

Recruitment contacts

Prof Simon Broadley
School of Medicine and Dentistry
Gold Coast Campus
Griffith University QLD 4222
Australia

Phone: +61 07 5678 0174
Email: simon.broadley@griffith.edu.au

Further details

For more information, please see the ANZCTR website.

Region

QLD

Ethics approval

Yes

Last updated

02/06/2022

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