Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial) | NCT00412256

Studies
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

NCT00412256

Sponsor

Humanis Klinikum Niederosterreich

Status

Completed

Last Update Posted

Dec 18, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

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

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Dec 15, 2006

First Submission Date that Met QC Criteria

Dec 15, 2006

First Posted Date

Dec 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2006

Last Update Posted Date

Dec 18, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Omegaven (10% fish-oil emulsion; Fresenius-Kabi)	Drug

Measure	Description	Time Frame
DAS28

Measure	Description	Time Frame
ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burkhard F Leeb, MD	Center for Rheumatology Lower Austria; Humanisklinikum NÖ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria		Stockerau		A-2000	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16555468	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases