Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)
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|ClinicalTrials.gov Identifier: NCT00412256|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : December 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis|
|Study Start Date :||September 2004|
|Study Completion Date :||November 2006|
- ACR-criteria, M-HAQ, VAS pain, SF-36,co-medication consumption
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412256
|Center for Rheumatology Lower Austria, Humanisklinikum Lower Austria|
|Stockerau, Austria, A-2000|
|Principal Investigator:||Burkhard F Leeb, MD||Center for Rheumatology Lower Austria; Humanisklinikum NÖ|