NL-OMON50218招募中4 期
Effectiveness of adalimumab combined with adjuvant surgery versus adalimumab monotherapy in the treatment of hidradenitis suppurativa. - HS-COST
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following inclusion criteria:
- •1. Age >=18 years.
- •2. Moderate to (very) severe HS defined as a score of >=3 points on the PGA
- •(range 1-5)
- •3. Indication for adalimumab: uncontrolled disease (HS) under conventional
- •therapy and/or minor surgery.
- •4. A diagnosis of HS for more than six months prior to baseline.
- •5. Clearance of HS can reasonably be achieved with two surgical interventions
- •as based on consensus between two dermatosurgeons.
- •6. Willing and able to undergo general anaesthesia.
- •7. Able and willing to give written informed consent and to comply with the
- •study requirements.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. 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®).
- •2. Previous failure or current use of adalimumab or other anti-TNF-a therapy.
- •3. Current or recurrent clinically significant skin condition in the HS
- •treatment area other than HS.
- •4. Presence of other uncontrolled clinically significant major disease.
- •5. Pregnant and lactating women.
- •6. Malignancy (except basal cell carcinoma), lymphoproliferative disease or a
- •history of malignancy.
- •7. Current use of oral antibiotics (a washout period of 14 days is required).
- •8. Current use of oral corticosteroids (a washout period of 30 days is
- •9. Previous biologic use; a wash-out of at least 5 half-lifes.
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