median age and median disease duration was 41 years
(20-74 yrs) and 3years (1-32 yrs) resp. RF & erosions
were recorded in 59% and 40% resp.
(a) In the RDB, though the IRA-01 patients improved
significantly, they did not differ significantly from
the placebo (ACR 20: active= 60%, placebo=53%). (b)OLP:
The Table shows significant improvement (p<0.05) in
the mean values of clinical measures in the 58 patients
who completed 12 mths. (c)The mean RF at 6 mths showed
impressive reduction in the act group (0 mths= 364;
6 mths=212) while it worsened in the plb(0 mths =258,
Profile (mg/dl): At 3 mths, IRA-01 showed a significant
change(p<0.05) in HDL (baseline= 45.6 , increase=1.6
) and LDL(baseline=117.1; reduction=12.7)on comparison
to placebo ; a similar effect was seen at 1 year FU(
HDL= 47.1,LDL= 106.8).
Events (AE)/Withdrawals: Only mild clinical AE /toxicity
(mostly related to GIT -gastritis, anorexia, nausea)
reported; no difference between active and placebo.
38 patients (29%) withdrew during RDB (failure in follow
up or test drug compliance).