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- The percentage of participants in complete remission at 12 and 18 months after randomization.
- The cumulative BVAS/WG AUC during the 6, 12, and 18 months after randomization.
- 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.
- The percentage of participants who achieve a BVAS of 0 on prednisone <10 mg/day at 6, 12, and 18 months after randomization.
- The percentage of participants who achieved remission after blinded crossover.
- The cumulative steroid dose between groups for participants at 6, 12, and 18 months.
- The number of severe flares in participants at 6, 12, and 18 months.
- The number of limited flares in participants at 6, 12, and 18 months.
- The percentage of participants in each study arm who were considered treatment failures (See Table 4) before month 6.
- The percentage of participants who withdraw from the study or treatment because of drug intolerance (e.g., emesis, infusion reactions).
- Laboratory markers of inflammation (ESR and CRP).
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