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.

Phase 2

Recruiting

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12621001502820
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-04
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of autoimmune adverse events (time to event)<br><br>Assessed via Monitoring visits , MRI scans, blood tests, liver function tests and urine tests <br><br>[ Time point: at 3 years post trial commencement (31/12/2024)<br><br>Monitoring Visits (every 6 months) intercurrent illness, relapse history and concomitant medications, EDSS change, MSIS-29 change<br><br>MRI every 12 months - Looking for Number of new T2 MRI brain lesions, Number of new Gd-enhancing lesions<br><br>FBC/lymphocyte subsets – lymphocyte subsets will be performed at weeks -1, 4, 9, 13, 26, 35, 50, 57, 61, 65, 78, 83 and 104. - B cell subpopulation counts at theses times<br>]

Secondary Outcome Measures

Name	Time	Method
To assess the safety and efficacy (MS disease activity related) of this therapeutic approach. <br>To assess the profile of the immune repertoire of T and B-cells that re-emerge with this therapeutic approach. Assessed via Monitoring visits , MRI scans, blood tests, liver function tests and urine tests<br>[ Time point: at 3 years post trial commencement (31/12/2024)<br><br>Monitoring Visits (every 6 months) intercurrent illness, relapse history and concomitant medications, EDSS change, MSIS-29 change<br><br>MRI every 12 months - Looking for Number of new T2 MRI brain lesions, Number of new Gd-enhancing lesions<br><br>FBC/lymphocyte subsets – lymphocyte subsets will be performed at weeks -1, 4, 9, 13, 26, 35, 50, 57, 61, 65, 78, 83 and 104. - B cell subpopulation counts at theses times<br>]