Rheumatoid Arthritis Clinical Trial
Official title:
Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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