Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Sponsor

Humanis Klinikum Niederosterreich (Other)

Overall Status

Completed

CT.gov ID

NCT00412256

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2004

Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

DAS28 []

Secondary Outcome Measures

ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)