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An intensive protocol of treatment with DMARDs might prove more beneficial than conventional regimens in patients with early rheumatoid arthritis (RA).The objective of this study was to assess whether an intensive strategy of methotrexate treatment using a strict protocol, as determined by a computerized decision program, results in better outcomes than the conventional methotrexate strategy in patients with early RA.From 1999 to 2003,individuals (age >16 years) with early RA (disease duration <1 year)were enrolled in this open-label, multicenter trial, and started on an initial dose of oral methotrexate 7.5 mg/week. Patients were randomly allocated to either the intensive treatment strategy (n = 151), which involved outpatient visits every 4 weeks and use of a computer decision program to assess disease response according to predefined criteria, or to the conventional treatment strategy (n = 148), which involved outpatient visits every 3 months and assessment of response based on the number of swollen joints. In both groups, the dose of methotrexate was increased stepwise by 5 mg/week (to a maximum dose of 30 mg/week) if patients had shown inadequate response compared to the previous visit, and decreased stepwise by 2.5 mg/week if they had shown sustained response. Ciclosporin was added to the regimen in patients who continued to show no sustained response despite receiving the maximum dose of methotrexate.The primary outcome measure was the number of patients in remission for at least 3 months at any time during the 2-year trial.Significantly more patients in the intensive strategy group achieved at least one period of remission compared with the conventional strategy group, in both the first year of the study (53 [35%] versus 21 [14%], P <0.001) and over 2 years (76 [50%] versus 55 [37%], P = 0.029). Mean time to the first period of remission was significantly shorter in the intensive strategy group than in the conventional strategy group (10.4 months versus 14.3 months, P <0.001),and the total duration of all periods of remission significantly longer (11.6 months versus 9.1 months, P = 0.025). The majority of clinical disease activity parameters improved significantly within the first year in the intensive treatment group, but were similar in the two groups at 2 years. The mean dose of methotrexate in patients who completed the study was significantly higher in the intensive strategy group than in the conventional strategy group (16.1 mg/week [95%CI 14.8-17.3 ] versus 14.0 mg/week [95% CI 13.1-14.8 ], P = 0.008), and the mean maximum dose was 24.9 ± 6.5 mg/week and 18.2 ± 6.5 mg/week, respectively. A greater number of patients in the intensive treatment group than in the conventional treatment group reported adverse events and had to withdraw from the study owing to methotrexate-related adverse events.The clinical benefit of methotrexate in early RA can be improved by using a protocol that intensifies treatment on the basis of objective evaluation of core patient characteristics.