Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'
试验速览
- 阶段
- 4 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Cost-utility
研究概览
简要总结
The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy compared with the combination of adalimumab and a maximum of three surgeries after two years of treatment in adult patients with moderate to severe HS.
详细描述
The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy (Group A) with the combination of adalimumab and a maximum of three surgeries (Group B) years of treatment in adult patients with moderate to severe HS.
Patients in group A will be treated with adalimumab monotherapy according to normal clinical practice and will be given the possibility to crossover into Group B when they do not achieve the HiSCR after 6 months of treatment. Additionally patients will be offered treatment with infliximab, according to clinical practice, until the last surgery. Patients in group B will receive adalimumab combined with a maximum of three adjuvant excisions of active lesions, both according to routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Moderate to (very) severe HS defined as a score of ≥3 points on the PGA (range 1-5) and with a DLQI of at least 11 (range 0-30).
- •Indication for adalimumab: i.e. uncontrolled disease (HS) under conventional therapy and/or minor surgery.
- •A diagnosis of HS for more than six months prior to baseline.
- •Clearance of HS can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons.
- •Willing and able to undergo general anaesthesia or procedural sedation and analgesia.
- •Able and willing to give written informed consent and to comply with the study requirements.
排除标准
- •Contraindication for treatment with adalimumab (sepsis or risk of sepsis, active or latent tuberculosis, serious active local and/or chronic infections, heart failure NYHA class III/IV, severe liver disease, pre-existing HIV, active viral hepatitis, demyelinating disease, or allergy to adalimumab or any other ingredients of HUMIRA®).
- •Previous or current use of adalimumab or other anti-TNF-α therapy.
- •Current or recurrent clinically significant skin condition in the HS treatment area other than HS.
- •Presence of other uncontrolled clinically significant major disease.
- •Pregnant and lactating women.
- •Malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy.
- •Current use of oral antibiotics (a washout period of 14 days is required).
- •Current use of oral corticosteroids (a washout period of 30 days is required).
研究组 & 干预措施
Adalimumab Monotherapy
Adalimumab injections will be administered through subcutaneously in a weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued for 2 years in total.
干预措施: Adalimumab Injection (Drug)
Adalimumab + Surgery
Patients will be treated with a combination of adalimumab and wide excision, with a maximum of three surgical interventions within the first year. Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued until the last surgery.
干预措施: Wide Excision (Procedure)
Adalimumab + Surgery
Patients will be treated with a combination of adalimumab and wide excision, with a maximum of three surgical interventions within the first year. Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued until the last surgery.
干预措施: Adalimumab Injection (Drug)
结局指标
主要结局
Cost-utility
时间窗: 2 years
Cost-utility: costs / point change in QALY
次要结局
- Treatment satisfaction(2 years)
- High sensitivity CRP(2 years)
- Clinical efficacy using HiSCR(2 years)
- Clinical efficacy using change in HS-PGA(2 years)
- Clinical efficacy using the number of flares(2 years)
- Incidence and severity of treatment related adverse events(2 years)
- Cost-effectiveness(2 years)
- Quality of life using change in EQ-5D-5L(2 years)
- Quality of life using change in DLQI(2 years)
- Quality of life using change in Skindex-17(2 years)
- Cytokines(3 months)
- Identification of blood metabolite profiles(3 months)
- Identification of metabolites associated with treatment response(3 months)
- Change in parameters of metabolic syndrome(2 years)
- Change in parameters of pre-diabetes(2 years)
- Assessment of changes in metabolite (profiles)(3 months)
- Relation between adalimumab trough concentrations and treatment response(3 months)
- Predictive value of early dry-blood-spots(3 months)
- Objectively assessed therapy adherence using adalimumab trough concentrations(2 years)
- Relation between adalimumab trough concentrations in serum and skin samples(3 months)
- Influence of patient characteristics on adalimumab serum trough concentrations(3 months)
- Objectively assessed therapy adherence using collected syringes(2 years)
- Patient reported therapy adherence using a diary(2 years)
- Impact of surgery on quality of life measured with DLQI(8 weeks after each surgery)
- Impact of surgery on work productivity measured with WPAI(8 weeks after each surgery)
- Wound closure time(through study completion, an average of 15 months)
- Recurrence rate(through study completion, an average of 15 months)
研究者
M.B.A. van Doorn
Principal investigator
Erasmus Medical Center