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Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

This study has been completed.
Sponsor:
Information provided by:
Humanis Klinikum Niederosterreich
ClinicalTrials.gov Identifier:
NCT00412256
First received: December 15, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by Humanis Klinikum Niederosterreich:

Primary Outcome Measures:
  • DAS28

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

Estimated Enrollment: 60
Study Start Date: September 2004
Estimated Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412256

Locations
Austria
Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria
Stockerau, Austria, A-2000
Sponsors and Collaborators
Humanis Klinikum Niederosterreich
Investigators
Principal Investigator: Burkhard F Leeb, MD Center for Rheumatology Lower Austria; Humanisklinikum NÖ
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00412256     History of Changes
Other Study ID Numbers: GS4-EK-KAG/374
Study First Received: December 15, 2006
Last Updated: December 15, 2006
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Humanis Klinikum Niederosterreich:
Treatment
Disease activity
Clinical trial

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013