Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Intervention group: Infusions of omega-3 fatty acids once daily for 14 days (Infusion speed: 0.5 ml/kg body weight and hour), followed by oral administration of omega-3 fatty acids up to 6 months.
C
Sponsors
Medical University of Graz (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients at least 19 years of age and should not be older than 85 years 2. Patients suffering from Rheumatoid Arthritis (RA), according to American College of Rheumatology (ACR) criteria, for at least (>=) 6 months 3. Patients with active RA who meet following criteria: 3.1. >= 6 swollen joints 3.2. >= 6 tender joints 3.3. >= 1 of following criteria: a. Joint morning stiffness >= 45 minutes b. Erythrocyte Sedimentation Rate (ESR) >= 28 mm c. C-Reactive Protein (CRP) >= 20 mg/l (normal range: 0 - 9) 4. No pregnant or breast feeding women allowed; monthly negative pregnancy test in women of reproductive age 5. Participant doesn't have a severe concomitant physical or mental illness 6. Participant has to be able to follow the study procedures 7. No severe malfunctioning of the liver, kidneys, bone marrow, blood clotting system 8. Stable dosages of RA medication for at least 1 month prior to baseline: 8.1. DMARD therapy with methotrexate of at least 10 mg per week over 4 months 8.2. Prednisone <=10 mg daily 9. No injection of glucocorticoids into a joint within 3 month prior to baseline 10. Participant must not have legal conflict 11. Participant must not have alcohol or drug abuse problems 12. Written informed consent signed by the participant
Exclusion criteria
Exclusion criteria: 1. Known allergy against fish oil or any other substance of the study medication 2. Participant is younger than 19 years of age 3. Patient simultaneously participates in another trial 4. Participant doesn't sign the written informed consent. 5. No stable dosage of RA medication 1 month prior to baseline 6. Injection of glucocorticoids into a joint within 3 month prior to baseline 7. Pregnant or breast feeding women; positive pregnancy test in women of reproductive age 8. Patient has legal conflicts 9. Patient has alcohol or drug abuse problems 10. Severe concomitant physical or mental illness 11. Participant is physically or mentally unable to follow the study procedures 12. Hereditary disorder of lipid metabolism 13. Blood triglyceride levels >300 mg/dl 14. Patients with uncontrolled diabetes mellitus 15. Severe malfunctioning of the liver, kidneys, bone marrow, blood clotting system: 15.1. Creatinin clearance <=30 ml/min 15.2. Elevated levels of ALanine aminoTransferase (ALT) 2 fold above the upper normal range 15.3. Leucopenia <=2,500/ml, red blood cells <=2.5 mill/ml, hemoglobin <=9 mg/dl, platelets <=70,000/ml 16. Severe cardiovascular disease 17. Known neoplasms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline, during infusion phase (after week 1 and after week 2) and during capsule phase (after two weeks [end of month 1] and then monthly until the end of month 6): 1. Swollen joints 2. Tender joints 3. Erythrocyte Sedimentation Rate (ESR) 4. C-Reactive Protein (CRP) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline, during infusion phase (after week 1 and after week 2) and during capsule phase (after two weeks [end of month 1] and then monthly until the end of month 6): 1. Disease Activity Score (DAS) 2. Rheumatoid Arthritis Disease Activity Index (RADAI) 3. Health Assessment Questionnaire (HAQ) 4. 36-item Short Form health survey (SF-36) | — |
Countries
Austria
Outcome results
None listed