TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The FIN-RACo trial is an investigator initiated multicenter (n=15 centers in Finland)
prospective study on the treatment of patients with early rheumatoid arthritis (RA) with
combination therapy with disease modifying antirheumatic drugs starting with methotrexate,
sulphasalazine, hydroxychloroquine and prednisolone (COMBI). During the first 6 months, the
patients are randomized to treatment with infliximab/placebo added on the combination
treatment. The study is prospective for 5 years, with extension to 10 years. The target is to
induce remission in both treatment arms. To reach this target, the investigators use frequent
changes of doses and anti-rheumatic drugs and use of intra-articular glucocorticoid
injections. The primary endpoints are the proportions of patients with remission at 2 and 5
years in both treatment arms.
Phase:
Phase 4
Details
Lead Sponsor:
Helsinki University University of Helsinki
Collaborators:
Central Hospital of Kanta-Hame Jyväskylä Central Hospital Kanta-Häme Central Hospital Kuopio University Hospital Lappi Central Hospital Orton Invalid Foundation Oulu University Hospital Rheumatism Foundation Hospital Satakunta Central Hospital Seinajoki Central Hospital South Carelia Central Hospital South Karelia central hospital University of Turku