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.

Griffith University0 个研究点目标入组 80 人开始时间: 2021年11月4日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•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

•-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

发起方