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Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412256
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 18, 2006
Information provided by:
Humanis Klinikum Niederosterreich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
Study Start Date : September 2004
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. DAS28

Secondary Outcome Measures :
  1. ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412256

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Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria
Stockerau, Austria, A-2000
Sponsors and Collaborators
Humanis Klinikum Niederosterreich
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Principal Investigator: Burkhard F Leeb, MD Center for Rheumatology Lower Austria; Humanisklinikum NÖ
Layout table for additonal information Identifier: NCT00412256    
Other Study ID Numbers: GS4-EK-KAG/374
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: December 18, 2006
Last Verified: December 2006
Keywords provided by Humanis Klinikum Niederosterreich:
Disease activity
Clinical trial
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases