Fish oil in recent onset rheumatoid arthritis: High versus low dose fish oil on a background of dose-responsive combination disease-modifying anti-rheumatic drugs.

Phase 3

Completed

• Conditions: rheumatoid arthritis; Inflammatory and Immune System - Rheumatoid arthritis; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613000579796
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-02-17
• Study Start: 2013-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

subjects must be 18 years or older, have rheumatoid arthritis (RA) according to the 1987 revised ACR criteria with polyarthritis of less than 12 months’ duration, at least 3 swollen joints and ESR greater than 28 mm/hour and/or CRP greater than 10 mg/dL and be DMARD-naive.

Exclusion Criteria

use of DMARDs other than antimalarials, use of antimalarials for more than 1 month, recent seroconversion to parvovirus, Ross River, Barmah Forest or rubella viruses, antinuclear antibody titre greater than 1:320, hepatitis B, hepatitis C or human immunodeficiency virus, known sensitivity to methotrexate, sulphasalazine or hydroxychloroquine, or systemic disease likely to increase the risk of toxicity to 1 or more of these drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The design of this RCT has allowed the effects of fish oil to be assessed in the context of modern disease-modifying anti-rheumatic drugs (DMARD) treatment for RA. A structured treatment algorithm responsive to disease activity and tolerance, allows drug use to be used as an outcome measure for the effects of fish oil. Specifically, doses of combination DMARDs (methotrexate, sulphasalazine, hydroxychloroquine) are increased until the target disease activity is reached (a treat-to-target strategy). The primary endpoint is time to failure of this triple therapy, requiring addition of another DMARD leflunomide. [12 months]

Secondary Outcome Measures

Name	Time	Method
time to achieving remission according to ACR criteria (joint scores, patient reported outcomes, inflammatory markers)[12 months]