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

Phase 1

Conditions: M06
M05
Other rheumatoid arthritis
Seropositive rheumatoid arthritis

Registration Number: DRKS00005323

Lead Sponsor: Immanuel Krankenhaus Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Activity after 24 weeks treatment measured by DAS 28 (disease activity score)

Secondary Outcome Measures

Name	Time	Method
- patients with low disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24<br>- patients with low disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 12<br>- improvement of functional status measured by FFbH from baseline to week 24<br>- ACR20, ACR50, ACR70 from baseline to week 24<br>- ACR 20, ACR50, ACR70 from baseline to week 12<br>descriptive analysis of change glucocorticoids, NSAID dosage<br>- report of adverse events and serious adverse events (referring to ICH GCP / CPMP ICH E2)<br>- changes of CRP and ESR from baseline to week 24<br>- changes of immunological parameters after week 24