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: 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 3)To evaluate the efficacy of filgotinib in establishing perianal fistula closure 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 3)To evaluate the efficacy of filgotinib in establishing perianal fistula closure at Week 58