Safety and efficacy of oral tofacitinib versus betamethasone oral mini-pulse therapy in the treatment of progressive non-segmental vitiligo: a pilot randomized clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients with disease arrest (no new lesions and no progression of pre-existing patches) at every visit as confirmed on sequential photographs
研究概览
简要总结
There is an unmet need for a non-steroidal safe and effective treatment for arresting progressive vitiligo. There are reports of tofacitinib causing re-pigmentation in vitiligo, but its effect on disease progression is not known. Aim of this study is to compare the safety and efficacy of oral tofacitinib with OMP in treating progressive vitiligo.
Research Question
What is the safety and efficacy of oral tofacitinib compare to betamethasone oral mini pulse in treatment of progressive non-segmental vitiligo?
Null hypothesis
Oral tofacitinib is inferior to betamethasone oral mini pulse in treating progressive vitiligo.
Alternate hypothesis
Oral tofacitinib is non-inferior to betamethasone oral pulse in treating progressive vitiligo.
Aims and Objectives
1. Primary objective
To compare the efficacy of oral tofacitinib versus betamethasone oral mini-pulse in arresting disease activity in patients with progressive non-segmental vitiligo
2. Secondary objectives
2.1 To compare re-pigmentation with oral tofacitinib versus betamethasone oral mini-pulse
2.2 To compare the change in quality of life in patients receiving oral tofacitinib versus betamethasone oral mini-pulse
2.3 To compare the side effects profile of oral tofacitinib versus betamethasone oral mini pulse
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with rapidly progressive non segmental vitiligo with more than or equal to 5 new lesions in a month or more than or equal to 15 new lesions in 3 months.
排除标准
- •Patients with segmental or stable or slowly progressive vitiligo
- •Pregnant or lactating females
- •Patients with known contraindictions to oral steroids or tofacitinib
- •Patients on topical treatment for last 2 weeks or systemic treatment for 4 weeks
- •Patients with latent tuberculosis infection not willing to take isoniazid preventive treatment.
结局指标
主要结局
Proportion of patients with disease arrest (no new lesions and no progression of pre-existing patches) at every visit as confirmed on sequential photographs
时间窗: at 4, 8, 12, 16, 20 and 24 weeks (at every visit)
次要结局
- Mean number of new vitiligo lesions during the study period (intra- and inter group comparison)(at every visit)
- Mean VSAS score during the study period (intra- and inter group comparison)(at every visit)
- Proportion of patients in different VIDA score categories (inter-group comparison)(at every visit)
- Mean VDAS and VDIS scores during the study period (intra- and inter group comparison)(at 3rd and 6th month visit)
- Mean VES (intra- and inter group comparison)(at baseline, 3rd and 6th month visit)
- Mean VIS-22 scores (intra- and inter group comparison)(at baseline, 3rd and 6th month visit)
- Proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison)(at 6th month visit)
- Proportion of patients with different GQ responses (inter-group comparison)(at every follow up visit)
- Comparison of side effects profile in both groups(at every follow up visit)
研究者
Sathvi KM
All India Institute of Medical Science, New delhi.