Comparative Efficacy of Maintenance immunomodulatory therapies in Myelin Oligodendrocyte Glycoprotein antibody associated disease- an open label randomised controlled trial with blinded outcome (CEM-MOG study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- The proportion of patients who remained relapse-free at 2 years while receiving each of the maintenance immunotherapies .
研究概览
简要总结
Introduction Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease MOGAD is a heterogeneous neuroimmunological disease with a spectrum of clinical manifestations which include optic neuritis myelitis encephalomyelitis or encephalitis alone or in combination. A considerable number of patients approximately 50 percent have a relapsing course. There is an absence of Level 1 evidence for choice of maintenance immunosuppression in these patients. A randomised controlled trial is needed to guide treatment decisions. This study will be the first ever randomised controlled trial in the world to evaluate the comparative efficacy of commonly used therapeutic maintenance immunomodulatory therapies among patients with MOGAD.
Objectives The primary objective is to compare the efficacy of Azathioprine or Mycophenolate Mofetil or Rituximab in preventing relapses among patients with MOGAD as defined by proportion of patients who are relapse free for at least 2 years of follow up.
Methods In this multicenter open label randomised trial with blinded outcomes all adult MOGAD patients diagnosed as per the Lancet 2023 criteria would be included and randomised equally in permuted block randomisation to receive either AZA or MMF or RTX. The proportion of patients who are relapse free at the end of the follow up period of 2 years would be calculated.
Expected outcome The study will help ascertain benefits of individual medications and help compare efficacy between them. Since there is no data on head to head comparative studies in this group of patients the study may help decide choice of medications among MOGAD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18 years and above).
- •Diagnosed with MOGAD with a typical clinical phenotype in the form of optic neuritis, myelitis, tumefactive demyelination and acute disseminated encephalitis/encephalomyelitis and positive MOG antibody using a cell based study and fulfilling the Lancet 2023 consensus criteria for MOGAD.
- •Not on active immunosuppression Written informed consent.
排除标准
- •Current or a prior history of receiving any form of immunomodulation other than oral steroids Diagnosis other than MOGAD Contraindication to the use of these agents Denial of consent.
结局指标
主要结局
The proportion of patients who remained relapse-free at 2 years while receiving each of the maintenance immunotherapies .
时间窗: Each patient will be followed up at 6,12,18,24 months.
次要结局
- Time to first relapse(Each patient will be followed up at 6,12,18,24 months.)
- EDSS at last follow up(Each patient will be followed up at 6,12,18,24 months.)
- Change of disease modifying treatment(Each patient will be followed up at 6,12,18,24 months.)
- Any adverse event(Each patient will be followed up at 6,12,18,24 months.)
- Any serious adverse event(Each patient will be followed up at 6,12,18,24 months.)
- Any Infection during study period(Each patient will be followed up at 6,12,18,24 months.)
研究者
Dr Rohit Bhatia
All India Institute of Medical sciences , New Delhi