Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over and randomized in this study. The primary objective of this study was to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib once daily for whom the dose was decreased to 100 mg once daily compared to participants remaining on 200 mg once daily.
Participants were planned to receive the blinded treatment until primary analysis time point. After unblinding at the study primary analysis time point, participants would have received unblinded treatment. The clinical trial was originally designed with the primary endpoint to be assessed at Week 48. Due to early termination of the study, none of the participants completed 48 weeks of treatment. All participants participated in blinded treatment period only and the study was unblinded globally after study completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Administered orally once daily
Administered orally once daily
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS)
The mMCS is a tool designed to measure disease activity for ulcerative colitis. The mMCS was calculated as the sum of the 3 subscores: stool frequency, rectal bleeding, and endoscopy. Each subscore was graded from 0 to 3 with higher scores indicating more severe disease activity. The total mMCS score ranged from 0 to 9 with higher scores indicating more severe disease activity. The mMCS remission was defined as a total score of score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0. Corticosteroid-free mMCS remission was defined as being free of corticosteroids for at least 12 weeks.
Time frame: Week 48
Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare
PRO2 flare was defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1. PRO2 included items of stool frequency and rectal bleeding. The range of each item score was 0 to 3 with higher scores indicating more severe disease.
Time frame: Baseline up to Week 48
Time to ES-Confirmed UC Flare
An ES-confirmed UC flare was defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. Each subscore graded from 0 to 3 with higher scores indicating more severe disease.
Time frame: Baseline up to Week 48
Change From Baseline in C-Reactive Protein (CRP)
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity.
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Fecal Calprotectin (FCP)
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University of Miami
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Gastro Center of Maryland - Columbia
Columbia, Maryland, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Universitair Ziekenhuis Leuven Campus Gasthuisberg
Leuven, Belgium
Hepato-Gastroenterology HK
Hradec Králové, Czechia
GEP Clinic
Prague, Czechia
CHU Amiens-Picardie
Amiens, France
Centre Hospitalier Universitaire Hôpital Nord Service D'Hépato-Gastro-Entérologie
Marseille, France
...and 40 more locations
Fecal calprotectin, a very stable biomarker, was a 36 kilodalton calcium and zinc binding protein of S-100 protein family which was neutrophil derived. It represents 60% of cytosolic proteins in neutrophils and was a measurement of neutrophil migration to the gastrointestinal tract.
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, and Week 48
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
The IBDQ is disease-specific questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in participants with the Inflammatory Bowel Disease (IBD). It comprised of 32 questions divided into four health subscales: bowel symptoms (10 questions); systemic symptoms, including sleep disorders and fatigue (5 questions); emotional function such as depression, aggression, and irritation (12 questions); and social function, meaning the ability to participate in social activities and to work (5 questions). The IBDQ total score was calculated as the sum of the responses (each ranging from 1 \[severe problem\] to 7 \[normal health\]) to all 32 questions. Total IBDQ score ranged from 32 to 224 with a higher score indicating a better HRQoL.
Time frame: Baseline, Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
An adverse event (AE) was any untoward medical occurrence, new or worsening of any preexisting condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with this treatment. A TEAE was defined as * An AE which had a start date equal to or after the date of the first administration of study drug in this study and no later than 30 days after last administration of study drug. * And was either a newly reported event, or a worsening of an existing event. Serious TEAE was defined as a TEAE that * Resulted in death and was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly / birth defect; * Was medically significant.
Time frame: Baseline up to Week 48