Clinical trial NCT00412256: Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
Official title: Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Treatment
Disease activity
Clinical trial
Lead sponsor: Humanis Klinikum Niederosterreich
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: DAS28
Secondary outcomes:
measure: ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
Other outcomes:
Locations:
city: Stockerau
country: Austria
facility: Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria
Study officials:
affiliation: Center for Rheumatology Lower Austria; Humanisklinikum NÖ
name: Burkhard F Leeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/11745-006-5066-x.