Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanis Klinikum Niederosterreich

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)