DRKS00005323尚未招募1 期
Trichuris suis ova (TSO) as an additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study - TSORA
Immanuel Krankenhaus Berlin0 个研究点目标入组 50 人开始时间: 2013年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •male and female patients aged between 18 and 70 years
- •- capable of understanding and signed informed consent form (AMG §40(1) 3b)
- •- patients with definite rheumatoid arthritis to the ACR/ EULAR Classification Criteria 2010
- •- DAS 28 > 3,2
- •- Tender-Joint-Count (TJC) = 4, Swollen-Joint-Count (SJC) = 2
- •- CRP > 5mg/l oder ESR > 15 mm/h
- •- stable methotrexate therapy with dosage between 10-30mg/ week parenteral (s.c.) or oral use
- •- no DMARD oder biologigs therapy 4 weeks prior to TSO treatment (exeption:Rituximab during the last 5 months prior to screening)
- •- Prednisolon Therapy max. 10mg/d 2 weeks prior to TSO treatment
- •- stable NSAR treatment
- •- stable analgetic treatment
- •- oral medication possible and wanted
- •- Women: highly effective contraception
排除标准
- •- gastroinstinal disease like inflammatory bowel disease, peptic ulcer, divertikulitis
- •- resection of parts of the small intenstine
- •- active helminth infection
- •- active infection
- •- in treatment for cancer
- •- clinical relevant liver disease (cancer, hepatitis B or C)
- •- alcohol abuse
- •- clinical relevant liver-, kidney-, bone marrow -disfunction defined by laboratory results:
- •bone marrow:Hb < 8,0 g/dl, WBC < 2,5/nl, Thrombozyten < 100/nl
- •okidney: GFR nach MDRD < 60 ml/min, Kreatinin > 2,0mg/dl
- •oliver: GOT oder GPT > 3x upper reference value, Bilirubin > 1,5 mg/dl; Pseudocholinesterase und/oder Quick < 80% lower standard value
- •- other rheumatologic diseases than RA
- •- psychiatric disease or disease restricting agreement or compliance of the study
- •- severe internal disease
- •- known allergy to TSO or parts of medication
- •- pregnancy or breast-feeding
- •- participation in other trial/ study during the last 3 months
- •- forensic hospitalisation
- •- deficient ability of agreement to handling of individual related data
- •- 3 weeks prior to TSO treatment antibiotic, antimykotic or antihelmintic treatment
- •- live vaccines 4 weeks prior to screening
- •- intramuscular, intravenous, intraarticular injektion of glucosteroids in the last 4 weeks
研究者
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