Assessment of efficacy of combination of low dose rituximab & low dose prednisolone vs low dose prednisolone in inducing repeat remission in rituximab treated pemphigus vulgaris patients who develop disease relapse : A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To find out which of the treatment option between the combination of low dose rituximab & low dose prednisolone versus low dose prednisolone alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remission
研究概览
简要总结
This is a Randomised controlled trial to find out which of the treatment option between the combination of low dose rituximab( single dose of 500mg) and low dose prednisolone (0.3mg/kg) versus low dose prednisolone (0.3mg/kg) alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remission.
Secondary objectives:
-
Comparison of time to achieve remission on minimal treatment
-
Comparison of time to achieve remission off treatment
-
Comparison of total cumulative dose of prednisolone required in both arms in a 9-month study period
-
Comparison of adverse effects between the groups
-
Comparison of frequency of repeat relapse within the 9-month study period
There is a lack of research that reports a suitable treatment of relapse in patients of PV who had achieved remission after treatment with standard rheumatoid arthritis protocol. To the best of our knowledge, this study is first of its kind to assess a better treatment option for relapse between low dose rituximab and low dose prednisolone. This will help in bridging the knowledge gap and will help in better treatment of PV relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
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 of PV diagnosed with the following criteria: Compatible clinical picture and positive DIF with IgG±C3 in intercellular pattern in epidermis/ epithelium
- •Patients of PV who had been treated with rituximab (2 doses of 1g each, 2 weeks apart) for induction of immediate preceding remission who have disease relapse defined as ‘Appearance of 3 or more new lesions in a month that do not heal spontaneously within 1-week in a patient who has achieved clinical remission’.
- •Relapse duration less than 3 months
- •Patients with PDAI less than or equal to 45 (mild to moderate relapse) 5.Patient of age between 18-70 years.
- •6.Patients willing to come to PGIMER as per requirement of treatment protocol for follow up.
排除标准
- •Refusal to give consent.
- •Pregnant and lactating women.
- •Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis
- •Abnormal liver function tests and renal function tests
- •Known cardiac arrhythmias or conduction abnormalities
- •Women of reproductive age who have not completed their families and are not willing for contraception until 12 months after completion of rituximab infusion.
- •Severely decreased bone marrow function
- •Known hypersensitivity to murine proteins
- •Patients who have known contraindications for oral prednisolone (uncontrolled diabetes, uncontrolled hypertension, peptic ulcer disease, glaucoma, central serous retinopathy, steroid induced psychosis).
结局指标
主要结局
To find out which of the treatment option between the combination of low dose rituximab & low dose prednisolone versus low dose prednisolone alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remission
时间窗: We expect a difference of 4 weeks in obtaining remission between the two groups
次要结局
- Proportion of patients in each group who achieve complete remission on minimal therapy(6 months)
- Proportion of patients in each group who achieve complete remission off therapy(7 months)
- Comparison of total cumulative dose of prednisolone required in both arms(5 months)
- Comparison of adverse effects between the groups(9 months)
- Comparison of frequency of repeat relapse within the 9-month study period(9 months)