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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

December 15, 2006
December 15, 2006
September 2004
Not Provided
DAS28
Same as current
No Changes Posted
ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
Same as current
Not Provided
Not Provided
 
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2006
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00412256
GS4-EK-KAG/374
Not Provided
Not Provided
Humanis Klinikum Niederosterreich
Not Provided
Principal Investigator: Burkhard F Leeb, MD Center for Rheumatology Lower Austria; Humanisklinikum NÖ
Humanis Klinikum Niederosterreich
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP