Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Disease activity, Clinical trial