The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Percentage of Participants Who Achieved Combined Fistula Response at Week 24
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Time frame: Week 24
Percentage of Participants Who Achieved Combined Fistula Remission at Week 24
Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections \> 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Time frame: Week 24
Time to Clinical Fistula Response up to Week 24
Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented.
Time frame: Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24
Time to Clinical Fistula Remission up to Week 24
Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented.
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University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States
University of South Florida South Tampa Campus
Tampa, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Louisville Clinical Trials Unit
Louisville, Kentucky, United States
John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic
Baltimore, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
...and 17 more locations
Time frame: Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24
Percentage of Participants Who Achieved Proctitis Remission at Week 24
The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (\>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score \> 2.
Time frame: Week 24