Status:
COMPLETED
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
Lead Sponsor:
Humanis Klinikum Niederosterreich
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with active rheumatoid ...
Detailed Description
The study can be considered a phase III trial (comparison of two licensed preparations in a non-approved indication). This controlled double blind trial aims to compare the effect of parenterally appl...
Eligibility Criteria
Inclusion
- written informed consent
- RA according to the ACR criteria
- active RA (DAS28 \> 4.0) at the screening visit
- insignificant DAS28-change (\<0.6) between screening and the first intervention
Exclusion
- age lower than 18 yrs.
- pregnancy and insufficient birth control
- lactation
- army service
- lack of independence
- relevant therapeutic or dietary changes during the last three months
- relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
- application of Omega-3 fatty acids during the last three months
- application of Omega-3 fatty acids intended for the study duration
- prednisolone \> 10 mg/day
- contraindication for Omegaven or Lipovenös (according to the label)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00412256
Start Date
September 1 2004
End Date
November 1 2006
Last Update
December 18 2006
Active Locations (1)
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1
Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria
Stockerau, Austria, A-2000