Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis
We want to study, whether early treatment with infliximab for 6 months started parallel with
the combination therapy of methotrexate, sulphasalazine, hydroxychloroquine and prednisolone
(COMBI) can induce quick remission in patients with early RA, if the remission can be
sustained after 6 months on patients continuing the COMBI treatment and can diminish the
risk of progression of erosive changes in patients with early RA, and if we can reduce costs
of the 2 treatment arms with respect to costs due to the disease.
100 patients with early RA will be included in the study. The patients are randomised into
COMBI + placebo or into COMBI +infliximab.
All patients are treated openly with COMBI, starting with a combination of methotrexate,
sulfasalazine, hydroxychloroquine and prednisolone. In addition, the patients are randomized
into a) infliximab or b) similar placebo. The COMBI treatment will be continued for 2 years,
but the infliximab/placebo will be given only during the first 6 months.
The patients will be evaluated clinically at week 0, 4, 6, 10, 14, 18, 22 and 26 (at the day
of infusion, prior to the infusion) and at months 8, 10, 12, 15, 18, 21, and 24 and at
annually thereafter till 10 years.
If a patient has adverse events due to individual drugs in the COMBI, the treatment can be
substituted by another DMARD.The disease activity will be measured according to the ACR core
set of disease activity.
Radiology of hands (PA projection) and feet (PA projection) at baseline and at 1, 2, 3, 4,
5, 7 and 10 years. We also will record sick leaves, loss of income, and work disability.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Remission by ACR criteria
Marjatta Leirisalo-Repo, MD, Prof
Finland: Finnish Medicines Agency