JPRN-jRCTs031180367已完成未知
A pilot study for the effect of infliximab on endothelial function in patients with psoriasis
TOYAMA SATOSHI0 个研究点目标入组 20 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
o significant improvement of the reactive hyperemia index between before the 1st administration and 4 hours after the 3rd administration of study drug, the primary endpoint, was showed. The secondary end point, significant PASI score improvement was showed between before the 1st administration and after the 3rd administration of study drug, which means it improved skin symptoms of psoriasis. There were no significant change of frequency or severity of adverse events by this study drug.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Patients diagnosed as having psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
- •2. Patients at the age of 20 - 80 years when written informed consent is obtained
- •3. Patients who meet either of the following two criteria; (i) insufficiently treated with systemic therapies including phototherapy and skin lesions covering more than 10% of body surface area, (ii) severe skin and joint symptoms refractory to pre-existing treatments and quality of life is highly disturbed.
- •4. Patients from whom written informed consent is obtained after the sufficient explanation and understanding of this study
排除标准
- •1. Patients who are treated with other biologics (including infliximab) within 3 months
- •2. Patients treated with cyclosporine within 2 weeks
- •3. Patients with the past history of severe hypersensitivity or anaphylaxis against infliximab or drugs including murine proteins.
- •4. Patients with or suspected of having malignancy
- •5. Patients with serious infection, such as sepsis and positivity of Hepatitis B virus antigen
- •6. Patients with active or the past history of tuberculosis
- •7. Patients with active or the past history of demyelinating diseases
- •8. Patients with congestive heart failure
- •9. Patients with serious liver diseases (more than 300 IU of AST or ALT)
- •10. Patients with serious kidney diseases (serum creatinine >= 2.0mg/dl)
- •11. Patients under or suspected of pregnancy
- •12. Patients under breast feeding
- •13. Patients who are regarded to be inappropriate for this study by doctors
研究者
相似试验
招募中
不适用
A pilot study for the effect of infliximab on endothelial function in patients with psoriasisPsoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasisJPRN-UMIN000027208The University of Tokyo Hospital25
已完成
3 期
A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's DiseaseBehcet DiseaseNCT02505568Janssen Korea, Ltd., Korea33
已完成
3 期
Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES)Extrathoracic SarcoidosisNCT03704610Assistance Publique - Hôpitaux de Paris31
已完成
3 期
Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki DiseaseKawasaki DiseaseNCT00760435University of California, San Diego196
已完成
3 期
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type PsoriasisPsoriasisNCT01177800Xian-Janssen Pharmaceutical Ltd.129