A Multicentre open label non inferior RCT in RRMS of rituximab and conventional therapy and way forward precision medicine with RRMS endophenotypic classification: RITREC.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
Multiple sclerosis (MS) is an autoimmune disorder affecting individuals in their reproductive years, significantly impacting physical, psychological, and socioeconomic well-being. Treating relapsing-remitting MS (RRMS) remains a challenge, as conventional therapies, though beneficial, lack robust efficacy in relapse rate reduction. Anti-CD20 therapy with Ocrelizumab is effective but poses significant financial burden, especially in resource-limited settings like India. Rituximab, a well established drug with similar mechanism, remains unapproved for RRMS despite its potential benefits. Our study aims to establish efficacy (reduction in Annual Relapse Rate, ARR as primary end point) and safety of Rituximab in RRMS and explore endophenotype variations in MS pathogenesis to optimize therapeutic strategies. RRMS patients with pre-determined eligibility criteria will be recruited from multiple centres and randomized into either the conventional therapy arm (as per institute protocol) or the Rituximab arm. Patients will be monitored at baseline, 30 ±10 days, 90±10 days, 180± 10 days, 365± 10 days and then every 180 days (if no clinical deterioration occurs). Serum samples will be analysed for CD4, CD8, CD56 and cell clustering done to classify endophenotypes, along with individual HLA typing. miRNA profiling would also be performed. We anticipate establishing Rituximab as non-inferior to conventional therapies, with study outcomes guiding future official treatment guidelines. Creation of database for endophenotypic profile in India and incorporating the same in RRMS treatment could lead to improved patient prognostication and therapy selection, exemplifying precision medicine. The study attempts to identify epigenetic modifications by miRNA profiling in RRMS patients and assess correlation with endophenotype variants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients with RRMS diagnosed as per the Mc. Donald’s revised criteria 2017, within last two years b) Age 18-55 years c) Therapy naive/ received last immunomodulation prior to more than six months or more than 5 half-lives of DMT d) willing to provide written consent e) for females of child bearing age consent to not plan pregnancy or use adequate appropriate non- hormonal contraception methods.
排除标准
- •a) Pregnancy b) age <18 or >55 years c) Any Demyelinating disease other than RRMS d) Organ failure (NYHA III or IV, Hepatic or renal failure) e) presence of infection specially evidence of Tuberculosis (latent or active in Rituximab therapy) / Triple serology positivity for one or more f) prior history of confirmed or suspected Progressive Multifocal Leukoencephalopathy (PML) for Rituximab arm g) Known ALI (acute liver injury)/ AKI (acute kidney injury) on prior exposure to drugs in the Conventional Arm or evidence of other serious organ damage that would hamper participation in study as per investigators opinion h) Severe Infusion related reaction and/ or hypersensitivity to any drug during prior exposure i) History of cancer requiring therapy in the last 10 years j) concomitant presence of other immune mediated disorders requiring therapy with other immunomodulating drugs.
研究者
Biman Kanti Ray
Bangur Institute of neurosciences