Table 5: Rave Outcome Measures

Primary
The percentage of participants who have a BVAS/WG of 0 and have successfully completed the glucocorticoid taper by 6 months after randomization.
Secondary
  1. The major adverse event rate, expressed as adverse events per participant-year during the 6, 12, and 18 months after randomization for the following adverse events combined (See Adverse Events Analysis).
  2. The two-sided 95% CI of the percentage of participants who have a BVAS/WG of 0 and have successfully completed the glucocorticoid taper by 6 months after randomization and two-sided 95% CI of the difference between the two arms.
  3. The duration of remission, the time to limited and/or severe flare after remission in the two treatment groups.
  4. The percentage of participants who meet the criteria for clinical tolerance (See Immune Tolerance) at 12 and 18 months after randomization and at the common closing date.
Tertiary
  1. The percentage of participants in complete remission at 12 and 18 months after randomization.
  2. The cumulative BVAS/WG AUC during the 6, 12, and 18 months after randomization.
  3. The percentage of participants who achieve and maintain partial remission (defined as having a BVAS/WG ≤ 2 and being off prednisone) at months 6, 12, and 18.
  4. The percentage of participants who achieve a BVAS of 0 on prednisone <10 mg/day at 6, 12, and 18 months after randomization.
  5. The percentage of participants who achieved remission after blinded crossover.
  6. The cumulative steroid dose between groups for participants at 6, 12, and 18 months.
  7. The number of severe flares in participants at 6, 12, and 18 months.
  8. The number of limited flares in participants at 6, 12, and 18 months.
  9. The percentage of participants in each study arm who were considered treatment failures (See Table 4) before month 6.
  10. The percentage of participants who withdraw from the study or treatment because of drug intolerance (e.g., emesis, infusion reactions).
  11. Laboratory markers of inflammation (ESR and CRP).