A study to compare the efficacy and safety of oral methotrexate versus tofacitinib in patients with moderate to severe alopecia areata
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
- •This will be assessed by comparing the proportion of patients in the two arms who achieve SALT score ≤ 20 at the end of therapy
研究概览
简要总结
Alopecia areata is an autoimmune disorder affecting hair-bearing areas, leading to psychosocial morbidity. In moderate to severe alopecia cases, conventional treatments are less successful and have greater side effects, rendering them challenging to treat. in this study, we are using two drugs named Tofacitinib and Methotrexate and we want to demonstrate the efficacy of methotrexate as monotherapy and also compare it to newer modalities like tofacitinib because there haven’t been any previous studies comparing the two. This study aims to prove that methotrexate is non-inferior to tofacitinib in moderate to severe AA patients. So that we can use methotrexate widely in AA cases. This study will also add scalp ALP activity in alopecia areata, as there aren’t many studies on this topic, and ALP activity can be used as a biomarker in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with SALT (severity of alopecia tool) score ≥ 40 at the time of screening.
- •(SALT score 100 is the maximum score, and SALT 0 is the minimum score)
- •Total duration of disease more than 6 months
- •Patients with minimal/ no response after an adequate trial of topical therapy.
排除标准
- •Pregnant and lactating women
- •Women with childbearing potential who are unwilling to follow reliable methods of contraception
- •Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for one month.
- •Patients with severe hepatic renal or other systemic diseases such as heart disease, peptic ulcer disease, stroke, chronic lung disease, and AIDS.
- •Pre-existing malignancy, bone marrow suppression, and thromboembolic events
- •Patients who are not willing to participate in the trial.
结局指标
主要结局
•This will be assessed by comparing the proportion of patients in the two arms who achieve SALT score ≤ 20 at the end of therapy
时间窗: At the end of 6 months of treatment
次要结局
- •Scalp hair assessment Patient-reported outcome (PRO): proportion of patients achieving a PRO score of 0 or 1 or 2 points improvement in patients who had a baseline score of 3 in two arms at 6 months(•Proportion of patients who achieve 90% improvement in SALT score in two arms)