Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
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.
Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis|
- ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412256
|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|