To date, 607 patients have been enrolled in the study at more than 130 clinical trial sites in 23 countries. Total enrollment in this event-driven trial is targeted for 740 patients and is expected to be complete around the end of the second quarter of 2008. The study requires a specified number of renal flare events to be observed. The Data Monitoring Board has completed two safety reviews of the study without identifying any safety concerns. To date, more than 350 patients have been treated in the trial with either the 300mg or 900mg dose.
The Phase III study is designed to assess the ability of Riquent treatment to delay the time to renal flare in lupus patients with a history of renal disease and with elevated levels of anti-dsDNA antibodies. Two interim efficacy analyses are planned in this event-driven trial. The first interim efficacy analysis is expected in the second quarter of 2008, while the second interim efficacy analysis is expected to occur around the end of 2008.