This double-blind trial investigated whether aggressive treatment regimens started early in the course of polyarticular juvenile idiopathic arthritis (poly-JIA) could induce clinical inactive disease (CID) within six months. An exploratory phase determined the rate of clinical remission on medication (six months of continuous CID) at twelve months.

A total of 85 children aged two to 16 years with polyarticular JIA of less than twelve months duration were randomised to methotrexate 0.5 mg/kg/wk (40 mg max), etanercept 0.8 mg/kg/wk (50 mg max), prednisolone 0.5 mg/kg/d (60 mg max) tapered to 0 by 17 weeks (Arm one), or methotrexate (same dose as Arm one), etanercept placebo, and prednisolone placebo (Arm two).

The primary outcome was CID at six months and was achieved in 17 of 42 (40%) of patients in Arm one and 10 of 43 (23%) in Arm two (X2 = 2.91; p = 0.088). After twelve months, nine patients in Arm one and three in Arm two achieved clinical remission on medication (p = 0.0534). There were no significant differences between the arms in adverse events.

The authors concluded that although the primary endpoint was not met, early aggressive therapy in this cohort resulted in substantial proportions of patients in both arms achieving CID by six months and clinical remission on medication within twelve months of treatment.