† Patients who were in clinical response 8 weeks after receiving a single STELARA® IV induction were randomised to placebo SC, STELARA® 90 mg SC q12w or STELARA® 90 mg SC q8w. All patients who completed Week 44 were eligible to enter and continue in the LTE at the investigator’s discretion. Symptomatic remission: stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Patients who had both stool frequency and rectal bleeding subscores missing at a visit were considered not to be in symptomatic remission for that visit. Patients who had a prohibited change in UC medication, an ostomy or colectomy, or used a rescue medication after clinical flare or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 visit were considered not to be in symptomatic remission.
‡ ITT population, dose-adjustment not considered a treatment failure.
§ Subsequent to completion of the maintenance study at Week 44, unblinding occurred and patients who were receiving placebo SC discontinued from the LTE.