Date

2020-03-11

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

Induction Study: 1)Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 2)Proportion of Participants Achieving Endoscopic Response at Week 10 Maintenance Study: 1)Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 2)Proportion of Participants Achieving Endoscopic Response at Week 58 [Induction Study: 1)Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [Time Frame: Week 10] 2)Proportion of Participants Achieving Endoscopic Response at Week 10 [Time Frame: Week 10] Maintenance Study: 1)Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [Time Frame: Week 58] 2)Proportion of Participants Achieving Endoscopic Response at Week 58 [Time Frame: Week 58]]

Next Version

Induction Study: To evaluate the efficacy of filgotinib in establishing perianal fistula closure at time frame- Week 10 Maintenance Study: To evaluate the efficacy of filgotinib in establishing perianal fistula closure at time frame - Week 58