COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

An open, randomised trial comparing two treatment strategies, COBRA and a modified COBRA-schedule, in patients with early RA. The secondary aim of this trial is to study the side effects of glucocorticosteroids on bone-and cartilage metabolism, insulin resistance and metabolic syndrome. A total of 160 patients will be included and treated according to the randomised treatment strategy untill week 52 and followed-up untill week 104.

Early, aggressive treatment of rheumatoid arthritis with DMARDs has been proven to lower disease activity and suppress radiologic progression. Moreover, combination therapy is shown to be superior to monotherapy. The COBRA therapy is effective in several trials, and the positive effect on radiologic progression sustained over time. In a recent trial (BeSt) comparing different treatment strategies the COBRA therapy and initial therapy with Infliximab (a TNF-blocker) were equally effective in improving functional ability and preventing radiographic damage. Apparently most rheumatologists and or patients have resistance in prescribing this therapy.

At baseline patients will be included and extensively examined. At decision moments, eg weeks 13, 26, 39, 52, 78 and 104, an independent research nurse will perform an assessment of the disease activity. This will be followed by a visit with the treating physician.

The study design randomizes the two treatment strategies, ie COBRA or a modified COBRA schedule.
In the first year patients will be seen frequently in order to follow disease-activity, side effects and
cardiovascular parameters. In the first year patients will be seen at 2, 4, 8, 13, 26, 39 en 52 weeks. Treatment will be adjusted according to the DAS44 score. In the
follow-up period of the second year patients will be seen every six months.