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

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006344-71-DE

Enrollment

Registered

2012-04-25

Start date

2013-02-08

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Trichuris suis ova Product Name: Trichuris suis ova Product Code: TSO Pharmaceutical Form: Oral suspension INN or Proposed INN: Trichuris suis ova Current Sponsor code: TSO Other descripti

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Evaluation of - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24 - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 12 - improvement of functional status measured by FFbH - ACR20, ACR50, ACR70 after week 24 - ACR20, ACR50, ACR70 after week 12 descriptive analysis of change glucocorticoids, NSAID dosage - report of adverse events and serious adverse events (referring to ICH GCP / CPMP ICH E2) - changes of CRP and ESR - changes of immunological parameters after week 24;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment	—

Measure

Time frame

Secondary end point(s): Evaluation of - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 24 - patients with lox disease activity (DAS 28 < 3,2) respectively remission (DAS 28 < 2,6) after Week 12 - improvement of functional status measured by FFbH - ACR20, ACR50, ACR70 after week 24 - ACR20, ACR50, ACR70 after week 12 descriptive analysis of change glucocorticoids, NSAID dosage - report of adverse events and serious adverse events (referring to ICH GCP / CPMP ICH E2) - changes of CRP and ESR - changes of immunological parameters after week 24;Timepoint(s) of evaluation of this end point: after 24 weeks of treatment

—

Countries

Germany

Contacts

Public ContactStudiensekretariat Naturheilkunde

Immanuel Krankenhaus Berlin

g.loibl@immanuel.de00493080505691

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026