The object of this study is to determine whether treatment of rheumatoid arthritis (RA) with a combination of fish oil and borage seed oil is superior to treatment with either oil alone. This study will also investigate the biochemical, immunological, and molecular mechanism responsible for the therapeutic effects of these fatty acids. Each patient will be followed for two years.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: fish oil  Drug: borage seed oil  Drug: combination fish oil and borage seed oil	Phase III

Further Study Details: 

Expected Total Enrollment:  260

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Definite RA with onset at > 16 years, with total disease duration of at least 6 months
• Active disease as manifested by at least 3 joints that are swollen and 6 joints that are tender at time of enrollment, and either an erythrocyte sedimentation rate >_28, or a CRP >1.4, or morning stiffness of at least 45 min
• Stable dose of DMARDs for 2 mos before baseline visit, with total duration of DMARD for 6 mos.
• All standard therapy for RA, including DMARDs and combinations of DMARDs will be allowed as long as doses have been stable for 2 mos
• Stable NSAID for 1 month before baseline if on an NSAID
• Stable prednisone dose of < 10 mg/day for 1 month before baseline visit, if on prednisone
• Ability to give and understand all elements of informed consent
• Absence of comorbid condition which, in the opinion of the physician-investigator, would render the patient unsuitable for the study
• Willingness to adhere to the clinical protocol.

Exclusion Criteria

• A diagnosis of inflammatory arthritis other than rheumatoid arthritis
• Chronic anticoagulation
• Hypersensitivity to fish or fish products or plant products
• A dose of prednisone of > 10 mg/day, or either a change in the prednisone dose or intra-articular corticosteroid injection within one month of the baseline evaluation
• An inability or unwillingness to use an effective form of contraception (females) during the duration of the study
• Pregnant and breast-feeding females
• Inability or unwillingness to adhere to the study diet
• Platelet count < 100,000/mm 3
• Hemoglobin < 9 g/dl
• Albumin < 3.3 g

Alabama
      UAB Arthritis Clinical Intervention Program, Birmingham,  Alabama,  35297,  United States
Connecticut
      New England Res. Associates, Bridgeport,  Connecticut,  06606,  United States
Florida
      Sarasota Arthritis Research Center, Sarasota,  Florida,  34239,  United States
      Lake Rheumatology, Tavares,  Florida,  32778,  United States
Massachusetts
      Health Associates of Taunton, Taunton,  Massachusetts,  02780,  United States
Minnesota
      St. Paul Rheumatology, St. Paul,  Minnesota,  55104,  United States
Missouri
      Missouri Baptist Medical Center, St. Louis,  Missouri,  63131,  United States
Nebraska
      Westroads Medical Group, Omaha,  Nebraska,  68114,  United States
New Jersey
      Steven Golombek, Dover,  New Jersey,  07801,  United States
New York
      Joel M. Kremer, Albany,  New York,  12206,  United States
      Wadsworth Center Clinical Endocrinology Immunology, Albany,  New York,  12201,  United States
      Albany Medical College Rheumatology Division, Albany,  New York,  12209,  United States
      Hospital for Joint Diseases, New York,  New York,  10003,  United States
Pennsylvania
      Bruce I. Hoffman, Philadelphia,  Pennsylvania,  19152,  United States
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States
      Geisinger Medical Center, Danville,  Pennsylvania,  17822,  United States
      Rheumatic Disease Associates, Willow Grove,  Pennsylvania,  19090,  United States
South Carolina
      Piedmont Arthritis Clinic, Greenville,  South Carolina,  29601,  United States
Wisconsin
      University of Wisconsin Medical School, Madison,  Wisconsin,  53715,  United States

Study chairs or principal investigators

Robert B Zurier, MD,  Principal Investigator,  University of Massachusetts Medical School   

Study ID Numbers:  R01 AT000309-01A2
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  November 13, 2003
ClinicalTrials.gov Identifier:  NCT00072982
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08