Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Humanis Klinikum Niederosterreich

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00412256

GS4-EK-KAG/374

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind