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Sponsored by: |
Humanis Klinikum Niederosterreich |
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Information provided by: | Humanis Klinikum Niederosterreich |
ClinicalTrials.gov Identifier: | NCT00412256 |
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 arthritis.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis |
Estimated Enrollment: | 60 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | November 2006 |
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 applied fat emulsions on the disease activity of RA patients, as expressed by changes of the DAS28.
To test for the hypothesis patients are randomized and treated with 2ml/kg bodyweight of both preparations for seven consecutive days. These treatment cycles are repeated four times at monthly intervals. For not improving patients (DAS28 decrease <0.6) escapes before the third and the fourth treatment cycle are foreseen. In case of escape patients are treated with Omegaven in an open manner. Efficacy parameters comprise the DAS28, the ACR-criteria, the M-HAQ, the SF-36, and the co-medication consumption. To assess safety laboratory parameters, comprising, LFT, KFT, CBC, fasting glucose, cholesterol, HDL, LDL, neutral fat, and urinary analysis are performed. Moreover, blood pressure control and clinically examinations are performed on a regular basis. Study recruitment started in fall 2004 and was completed in November 2006.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria | |
Stockerau, Austria, A-2000 |
Principal Investigator: | Burkhard F Leeb, MD | Center for Rheumatology Lower Austria; Humanisklinikum NÖ |
Study ID Numbers: | GS4-EK-KAG/374 |
Study First Received: | December 15, 2006 |
Last Updated: | December 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00412256 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
Treatment Disease activity Clinical trial |
Chlorhexidine Autoimmune Diseases Musculoskeletal Diseases Chlorhexidine gluconate Joint Diseases |
Arthritis Omega 3 Fatty Acid Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |