Rheumatoid ArthritisPhase 3NCT00412256
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
A Phase 3 study testing Omegaven (10% fish-oil emulsion; Fresenius-Kabi) in people with Rheumatoid Arthritis, run by Humanis Klinikum Niederosterreich at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2004to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria
Stockerau, A-2000
About this study
Official title: Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
- Keywords
- Treatment, Disease activity, Clinical trial
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven (10% fish-oil emulsion; Fresenius-Kabi)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28
Secondary outcomes (1)
ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startSep 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Humanis Klinikum Niederosterreich
- Sponsor type
- University, hospital or other
- Investigators
- Burkhard F Leeb, MD, Principal investigator, Center for Rheumatology Lower Austria; Humanisklinikum NÖ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412256
- Sponsor's protocol ID
- GS4-EK-KAG/374
- Status last verified
- Dec 2006
- First submitted
- 15 Dec 2006
- Last updated
- 18 Dec 2006
- Results posted
- No
Publications
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.
PubMed 16555468
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00412256
- Acronym / sponsor ID
- GS4-EK-KAG/374
- Conditions
- Rheumatoid Arthritis
- Keywords
- Treatment, Disease activity, Clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Humanis Klinikum NiederosterreichUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Nov 2006
- First posted
- 18 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- age lower than 18 yrs.
- pregnancy and insufficient birth control
- lactation
- army service
- lack of independence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omegaven (10% fish-oil emulsion; Fresenius-Kabi) | Drug | – |
Primary outcome
DAS28
1 secondary outcome
ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2006.
- Background: PubMed 16555468Leeb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burkhard F Leeb, MD principal investigator
Center for Rheumatology Lower Austria; Humanisklinikum NÖ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omegaven (10% fish-oil emulsion; Fresenius-Kabi) in people with Rheumatoid Arthritis, run by Humanis Klinikum Niederosterreich at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2006.