Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study.

Immanuel Krankenhaus Berlin0 个研究点目标入组 50 人开始时间: 2012年4月25日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- 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)
•- other rheumatologic diseases than RA
•- pregnancy or breast-feeding
•- participation in other trial/ study during the last 3 months
•- intramuscular, intravenous, intraarticular injektion of glucosteroids in the last 4 weeks

发起方

Immanuel Krankenhaus Berlin