The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 2 year, 4 months
Time to relapse
Time frame: Up to 12-14 months
Participant compliance
Time frame: Up to 12-14 months
Number of participants in remission
Time frame: 12 months
Ulcerative colitis disease activity index (UC-DAI) score
Time frame: Baseline, Month 2, and Month 12
Patient questionnaire
Time frame: Month 6, and Month 12
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