EUCTR2011-006344-71-DE
Active, not recruiting
Phase 1
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 sites50 target enrollmentApril 25, 2012
ConditionsRheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsTrichuris suis ova
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- Immanuel Krankenhaus Berlin
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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