Comparison of efficacy and side effect profile of same day s[lit versus twice a week split of oral methotrexate in Rheumatoid Arthritis and comparison of Methotrexate poly glutamate levels in both groups: A randomised controlled study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess methotrexate polyglutamate levels and compare its levels between the two groups at Baseline, 3 and 6 months and change in disease severity measures (SDAI, CDAI and DAS28) at 24 weeks compared to baseline and side effect profile (symptomatic & labs) at 24 weeks
研究概览
简要总结
Methotrexate is a disease modifying anti-rheumatoid drug (DMARD) and an anchor drug used for treatment of Rheumatoid arthritis. Methotrexate is transformed in human body into its active metabolite, polyglutamate, whose half-life is 3 days. Anti-inflammatory effect is due to active form of methotrexate. Depending on the number of conjugated glutamates, MTX-PG may be present as MTX-PG1-5 or the longer chain MTX-PG (MTX-PG3-5) which is considered to be more active. MTX-PG3 is the most dominant and stable type of MTX-PG and could reflect the overall polyglutamate status. Studies show 28% higher bioavailability obtained when methotrexate dose is split and given 12 hours apart compared to single oral dose, resulting in superior efficacy. There are two methods of splitting methotrexate dose which are used commonly by rheumatologists across India. One is splitting dose in 2 days in a week, other is splitting methotrexate dose in a same day, 12 hours apart (morning and evening)
Rationale Of the Study: To look for any difference in methotrexate polyglutamate levels, efficacy, side effect profile in same day spilt and twice a week split of oral methotrexate in Rheumatoid Arthritis patients, as there is a lack of literature in this comparison
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling ACR/EULAR 2010 criteria of Rheumatoid Arthritis and having moderate disease activity, which is defined by DAS28 more than 3.2 2) Patients who are more than or equal to 18 years old 3) Patients taking oral methotrexate for at least 1 month prior to inclusion in this study 4) Giving consent for participation in the study.
- •Methotrexate dose 15mg/week 6) Not on other conventional synthetic or biological DMARDs except HCQ (400mg/day) or low dose prednisolone (7.5 mg/day).
排除标准
- •Patients having significant cytopenias Anemia (Hb less than 6 g/dl), thrombocytopenia (platelet count less than 1 ×105/mm3), leukopenia (less than 3000/mm3), ALT/AST more than 80 IU or serum creatinine more than 1.5 mg/dl.
- •Contraindications to methotrexate, which are severe renal, pulmonary and liver disease, pre- existing bone marrow suppression, alcoholic liver disease, pregnancy, breastfeeding or patients planning conception, acute or chronic HBV or HCV infection.
结局指标
主要结局
To assess methotrexate polyglutamate levels and compare its levels between the two groups at Baseline, 3 and 6 months and change in disease severity measures (SDAI, CDAI and DAS28) at 24 weeks compared to baseline and side effect profile (symptomatic & labs) at 24 weeks
时间窗: 1, 3 and 6 months
次要结局
- 1. To assess and compare Mean Glucocorticoid dose and NSAID score at 24 weeks between the two groups(2. To assess and compare Methotrexate intolerance severity score at 24 weeks between the two groups.)
研究者
Dr Rajat Gupta
King George Medical University