NCT00488631.

Trial name or title	A phase 3 multicenter, randomized, placebo‐controlled, double‐blind study to evaluate the safety and efficacy of golimumab maintenance therapy, administered subcutaneously, in subjects with moderately to severely active ulcerative colitis
Methods	Phase III, multicenter, randomized, double‐blind, placebo‐controlled trial
Participants	Adult patients (> 18 years) with ulcerative colitis in remission or response induced by golimumab
Interventions	Subcutaneous golimumab 100 mg administered every 4 weeks through week 52 Subcutaneous golimumab 50 mg administered every 4 weeks through week 52 Placebo
Outcomes	Primary outcome: number of participants in clinical response through week 54 Secondary outcomes: number of participants with clinical remission at both week 30 and week 54, number of participants with mucosal healing at both week 30 and week 54, number of participants with clinical remission at both week 30 and 54 among participants with clinical remission at week 0 of maintenance study, number of participants with clinical remission at week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at week 0 of maintenance study
Starting date	September 2007
Contact information	Janssen Research & Development, LLC
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