Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate

Phase 1

Conditions: Rheumatoid arthritis
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-006344-71-DE

Lead Sponsor: Immanuel Krankenhaus Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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

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

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)
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The effectiveness of trichuris suis ova (TSO) in rheumatoid arthritis patients in combination with methotrexate compared to methotrexate monotherapy ind patients with insufficient methotrexate monotherapy measured with the primary outcome parameter DAS 28 after 24 weeks.;Secondary Objective: Evaluation of<br>- 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) after Week 12<br>- improvement of functional status measured by FFbH<br>- ACR20, ACR50, ACR70 after week 24<br>- ACR 20, ACR50, ACR70 after 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<br>- changes of immunological parameters after week 24;Primary end point(s): Evaluation of DAS 28 after 24 weeks treatment;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of<br>- patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24<br>- patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 12<br>- improvement of functional status measured by FFbH<br>- ACR20, ACR50, ACR70 after week 24<br>- ACR20, ACR50, ACR70 after 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<br>- changes of immunological parameters after week 24;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment