A randomised placebo controlled crossover trial of leucovorin for methotrexate intolerance in rheumatoid arthritis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the change in MISA score (Methotrexate Intolerance Severity and Assessment in Adults) with and without leucovorin.
研究概览
简要总结
Rheumatoid arthritis is one of the most common autoimmune diseases, which is associated with joint swelling and later on deformities. Many of these patients are positive for rheumatoid factor or anticitrullinated peptide antibody. Methotrexate is the first line treatment for rheumatoid arthritis. However, a substantial proportion of patients (one-third to half) develop intolerance to methotrexate, i.e., they will get unpleasant symptoms on taking methotrexate like nausea, vomiting, headache, feeling lifeless. Many of those who develop intolerance will therefore drop out of treatment with methotrexate. There is some evdence that supplementing folic acid leads to some reduction in methotrexate intolerance. One folate moiety which has been used extensively in methotrexate toxicity is leucovorin (also called folinic acid), which is 5-methyl-folate. However, there is not much evidence on its effect on methotrexate intolerance.
LUMIRA trial will be a double blinded, randomised placebo controlled crossover trial to assess the efficacy of leucovorin 15 mg tablet taken once a week to reduce intolerance to methotrexate.
The study will e carried out on 60 consenting patients of Rheumatoid arthritis who are on methotrexate for attest 3 months and have developed intolerance, i.e, symptoms like nausea, headache etc to it for at least 1 month, with 30 of them receiving intervention medicine, that is leucovorin, in phase 1 of study and the other arm receiving placebo in the phase 1 and after 6 weeks, will be crossed over. There will be no washout period between two phases, as the half life of leucovorin is approximately 6 hours, and will be taken once a week. Patents will be followed up at 6 weeks and 12 weeks, at th end of both phases. We will be comparing the change in MISA (Methotrexate Intolerance Severity and Assessment Score) from baseline at 6 weeks and 12 weeks. The secondary outcomes will include measuring the change in Disease Activity Score (DAS 28), treatment adherence and patient preference with leucovorin versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The study recruits individuals aged
- •60 years, diagnosed with rheumatoid arthritis as per ACR/EULAR 2010 rheumatoid arthritis classification criteria, who are taking Methotrexate at any dose and any form for at least 3 months and have developed severe Methotrexate intolerance (with a Methotrexate intolerance and severity assessment in adults score (MISA) of 6 or more) for at least 1 month.
排除标准
- •include those who are already taking leucovorin, those who have abnormal liver function tests, cytopenias in one or more cell lines, methotrexate induced mucositis and skin rashes/ulcers, and those who are not willing to participate.
结局指标
主要结局
To compare the change in MISA score (Methotrexate Intolerance Severity and Assessment in Adults) with and without leucovorin.
时间窗: At 6 weeks and 12 weeks
次要结局
- Change in Disease Activity Score (DAS 28) from baseline, with and without Leucovorin.(At 6 weeks and 12 weeks)
- To assess treatment adherence using pill count, with and without leucovorin.(At 6 weeks and 12 weeks)
- To assess for patient preference using 5 point Likert scale, on leucovorin versus placebo.(At 6 weeks and 12 weeks)
研究者
Nuzhah V
Post Graduate Institute of Medical Education And Research