Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

December 15, 2006 updated by: Humanis Klinikum Niederosterreich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Stockerau, Austria, A-2000
        • Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
DAS28

Secondary Outcome Measures

Outcome Measure
ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanis Klinikum Niederosterreich

Investigators

  • Principal Investigator: Burkhard F Leeb, MD, Center for Rheumatology Lower Austria; Humanisklinikum NÖ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

December 18, 2006

Last Update Submitted That Met QC Criteria

December 15, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS4-EK-KAG/374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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