Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Rheumatoid Arthritis Clinical Trial

Official title:

Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412256
• Other study ID #: GS4-EK-KAG/374
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2006
• Last updated: December 15, 2006
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: December 2006
• Source: Humanis Klinikum Niederosterreich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Austria	Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria	Stockerau

Sponsors (1)

Lead Sponsor	Collaborator
Humanis Klinikum Niederosterreich

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28
Secondary	ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption