More patients in the combination-therapy group than in the methotrexate-alone group or the placebo group met the criterion for the primary end point ( 40 of 63 [ 63 % ] vs. 26 of 65 [ 40 % ] and 15 of 65 [ 23 % ] , respectively ; P = 0.009 for combination therapy vs. methotrexate alone ; P < 0.001 for combination therapy vs. placebo ) .