A randomised controlled trial to evaluate the efficacy, safety, and patient satisfaction with wide local excision and adalimumab versus adalimumab alone in managing moderate to severe Hidradenitis Suppurativa of the axilla.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Efficacy in terms of improvement in the International Hidradenitis Suppurativa Severity Score System (IHS4) and safety in terms of complications, adverse events and serious adverse events associated (drug and surgery related) with the two groups.
研究概览
简要总结
The rationale for this study is grounded in the hypothesis that the combination of surgical excision and biologic therapy addresses both the local and systemic components of HS. While surgery effectively removes chronic lesions and sinus tracts, adalimumab targets the underlying inflammatory pathways, potentially reducing recurrence rates and improving long-term outcomes.
We also wish to ascertain if patients with hidradenitis suppurativa lesions in sites that are amenable to surgical management have enough additional benefit from adding adalimumab to justify the increased cost of treatment.
This study has the potentialto significantly impact clinical practice by providing evidence-based guidelines for the comprehensive management of moderate to severe HS. It may help identify patient subgroups that benefit most from combined therapy, optimize treatment protocols, and improve patient quality of life. Additionally, understanding the safety profile of combined therapy will inform risk-benefit assessments in clinical decision-making.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients diagnosed with moderate to severe HS of the axillary region as per the Hidradenitis Suppurativa physician global assessment scale.
- •Patients should have one or more active lesions.
- •All patients should be on oral antibiotics two weeks before enrollment.
排除标准
- •Children less than 18 years of age, pregnant or lactating females, patients on oral corticosteroids within four weeks, patients on biologics within five-half-lives before baseline and clinically significant abnormal screening laboratory results as evaluated by the investigators.
结局指标
主要结局
Efficacy in terms of improvement in the International Hidradenitis Suppurativa Severity Score System (IHS4) and safety in terms of complications, adverse events and serious adverse events associated (drug and surgery related) with the two groups.
时间窗: 4 weeks, 12 weeks, 24 weeks
次要结局
- Patient satisfaction using global impression change.(Improvement in quality of life using DLQI, seven-day recall, work productivity, & activity impairment questionnaire as a measurement tool.)
研究者
Bhavni Oberoi
All India Institute of Medical Sciences