Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-11-30

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.

Conditions

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Rheumatoid Arthritis

Keywords

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Treatment Disease activity Clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Omegaven (10% fish-oil emulsion; Fresenius-Kabi)

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Burkhard F Leeb, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Rheumatology Lower Austria; Humanisklinikum NÖ

Locations

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Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria

Stockerau, , Austria

Site Status

Countries

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Austria

References

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Leeb BF, Sautner J, Andel I, Rintelen B. Intravenous application of omega-3 fatty acids in patients with active rheumatoid arthritis. The ORA-1 trial. An open pilot study. Lipids. 2006 Jan;41(1):29-34. doi: 10.1007/11745-006-5066-x.

Reference Type BACKGROUND

PMID: 16555468 (View on PubMed)

Other Identifiers

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GS4-EK-KAG/374

Identifier Type: -

Identifier Source: org_study_id