NCT00795574已完成2 期
Phase 2 Study to Assess the Safety and Efficacy of Infliximab for the Treatment of Hidradenitis Suppurativa
Florida Academic Dermatology Centers1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
研究概览
简要总结
A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person must have moderate to severe Hidradenitis suppurativa
- •Multiple ER or doctors visits related to HS
- •Intralesional kenalog injection >5/year, but none within 3 months of entry
- •HS >1 year duration
- •Failed systemic retinoids, but not within 3 months of entry
- •Failed at least one prior course of antibiotic therapy, which must not have been administered within 3 months of entry to the study (excluding the recommended antibiotic regimen given immediately before randomization for evidence of active infection
- •History of surgery (reconstructive), but not within 3 months of entry
排除标准
- •Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion
- •Known allergy against infliximab
- •Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
- •Have had any previous treatment with monoclonal antibodies or antibody fragments.
- •Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
- •Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- •Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 26 on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules.
- •Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
- •Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
- •Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
研究组 & 干预措施
infliximab
Experimental
Double blind placebo cross-over
干预措施: infliximab (Drug)
infliximab
Experimental
Double blind placebo cross-over
干预措施: Placebo Comparator (Drug)
Placebo
Placebo Comparator
Double blind placebo controlled cross-over
干预措施: Placebo Comparator (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Infliximab for Treatment of Immune Checkpoint Inhibitor ColitisMelanoma Stage IIIMelanoma Stage IVSkin Cancer Stage IIISkin Cancer Stage IVDrug-Induced ColitisDrug ToxicityImmune-related Adverse EventNCT04305145Massachusetts General Hospital42
已完成
2 期
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related CachexiaCachexiaPancreatic NeoplasmsNCT00060502Centocor, Inc.73
已完成
2 期
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type PsoriasisPsoriasisNCT00230529Centocor, Inc.249
已完成
3 期
A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPDCOPDChronic Obstructive Pulmonary DiseaseNCT00056264Centocor, Inc.234
已完成
2 期
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis SuppurativaHidradenitis SuppurativaNCT00918255Abbott154