3 fatty acids as adjuvant therapy in rheumatoid arthritis (N3-fettsäuren als adjuvante therapie bei rheumatoider arthritis)

Completed

Conditions: Rheumatoid arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN48092875

Lead Sponsor: Medical University of Graz (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):<br>1. Swollen joints<br>2. Tender joints<br>3. Erythrocyte Sedimentation Rate (ESR)<br>4. C-Reactive Protein (CRP)

Secondary Outcome Measures

Name	Time	Method
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):<br>1. Disease Activity Score (DAS)<br>2. Rheumatoid Arthritis Disease Activity Index (RADAI) <br>3. Health Assessment Questionnaire (HAQ)<br>4. 36-item Short Form health survey (SF-36)