Crohn's Disease
Conditions
Brief summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).
Interventions
DRUGFilgotinib
Tablet administered orally once a day
DRUGPlacebo
Tablet administered orally once a day
Sponsors
Gilead Sciences
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants received blinded treatment during different phases in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial * Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD * Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment * Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol * Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug * Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD Key
Exclusion criteria
* Known hypersensitivity to the study drug * Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol * Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol * Use of prohibited concomitant medications as outlined in the study protocol NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From the First Dose to Week 312 | An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit. The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline for number of liquid or very soft stool per day was reported. |
| Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline in abdominal pain was reported. |
| Change From Baseline in CDAI Scores | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in 37 countries: Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, the Netherlands, New-Zealand, Poland, Portugal, Republic of Korea, Romania, Russia, Serbia, Singapore, Slovakia, South-Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, the United Kingdom, and the United States (US).
Pre-assignment details
Participants with Crohn's disease (CD), who had completed or met protocol-specified efficacy discontinuation criteria from previous parent studies (GS-US-419-4015 \[NCT03046056\], GS-US-419-4016 \[NCT03077412\] or GS-US-419-3895 \[GLPG0634-CL-309\] \[NCT02914561\]) were rolled-over to this long-term extension study. Sponsor decided not to pursue extension of filgotinib indication for CD, as GS-US-419-3895 did not meet the co-primary endpoint and decided to terminate this study prematurely.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib 200 mg Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg.
Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study.
Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). | 944 |
| Filgotinib 100 mg Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg.
Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study.
Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). | 119 |
| Placebo Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation.
Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks). | 124 |
| Total | 1,187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 298 | 35 | 25 |
| Overall Study | Current Study Unblinded and participant confirmed on Placebo | 0 | 0 | 55 |
| Overall Study | Death | 3 | 1 | 1 |
| Overall Study | Enrolled but not treated | 1 | 0 | 0 |
| Overall Study | Investigators discretion | 169 | 14 | 13 |
| Overall Study | Lost to Follow-up | 10 | 4 | 0 |
| Overall Study | Non-compliance with study drug | 6 | 1 | 0 |
| Overall Study | Pregnancy | 8 | 0 | 0 |
| Overall Study | Protocol Violation | 5 | 3 | 0 |
| Overall Study | Sponsors decision | 287 | 41 | 12 |
| Overall Study | Withdrawal by Subject | 158 | 20 | 18 |
Baseline characteristics
| Characteristic | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 13.6 | 47 years STANDARD_DEVIATION 13.28 | 42 years STANDARD_DEVIATION 12.42 | 40 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 5 Participants | 0 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 904 Participants | 112 Participants | 123 Participants | 1139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 2 Participants | 1 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 137 Participants | 18 Participants | 23 Participants | 178 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 10 Participants | 3 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 47 Participants | 2 Participants | 2 Participants | 51 Participants |
| Race (NIH/OMB) White | 739 Participants | 89 Participants | 96 Participants | 924 Participants |
| Sex: Female, Male Female | 514 Participants | 33 Participants | 56 Participants | 603 Participants |
| Sex: Female, Male Male | 430 Participants | 86 Participants | 68 Participants | 584 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 944 | 2 / 119 | 1 / 124 |
| other Total, other adverse events | 697 / 944 | 89 / 119 | 78 / 124 |
| serious Total, serious adverse events | 284 / 944 | 34 / 119 | 20 / 124 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.
Time frame: From the First Dose to Week 312
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Filgotinib 200 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 820 Participants |
| Filgotinib 100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 103 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 96 Participants |
Secondary
Change From Baseline in CDAI Scores
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Time frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Population: Participants from safety analysis set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 96 | -118.6 units on a scale | Standard Deviation 131.49 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 216 | -137.0 units on a scale | Standard Deviation 147.14 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 156 | -121.4 units on a scale | Standard Deviation 132.33 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 24 | -98.5 units on a scale | Standard Deviation 122.68 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Baseline | 280.5 units on a scale | Standard Deviation 116.58 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 300 | -32.5 units on a scale | Standard Deviation 92.99 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 48 | -110.2 units on a scale | Standard Deviation 125.08 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 12 | -86.8 units on a scale | Standard Deviation 114.02 |
| Filgotinib 200 mg | Change From Baseline in CDAI Scores | Change at Week 264 | -134.8 units on a scale | Standard Deviation 128.86 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 96 | -23.3 units on a scale | Standard Deviation 91.94 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 24 | -30.8 units on a scale | Standard Deviation 92.92 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 48 | -40.9 units on a scale | Standard Deviation 91.47 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 156 | -33.5 units on a scale | Standard Deviation 99.15 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 216 | -57.5 units on a scale | Standard Deviation 121.12 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 264 | -171.5 units on a scale | Standard Deviation 141.81 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Baseline | 189.9 units on a scale | Standard Deviation 112.73 |
| Filgotinib 100 mg | Change From Baseline in CDAI Scores | Change at Week 12 | -29.1 units on a scale | Standard Deviation 79.84 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 48 | 0.6 units on a scale | Standard Deviation 49.32 |
| Placebo | Change From Baseline in CDAI Scores | Baseline | 120.4 units on a scale | Standard Deviation 81.33 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 24 | 5.7 units on a scale | Standard Deviation 51.3 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 156 | 0.3 units on a scale | Standard Deviation 59.27 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 96 | 11.0 units on a scale | Standard Deviation 69.29 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 12 | 4.2 units on a scale | Standard Deviation 53.42 |
| Placebo | Change From Baseline in CDAI Scores | Change at Week 216 | 2.5 units on a scale | Standard Deviation 37.76 |
Secondary
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit. The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline for number of liquid or very soft stool per day was reported.
Time frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Population: Participants from safety analysis set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline | 5.6 Number of liquid/very soft stools/day | Standard Deviation 3.26 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 12 | -1.6 Number of liquid/very soft stools/day | Standard Deviation 2.71 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 264 | -2.0 Number of liquid/very soft stools/day | Standard Deviation 2.86 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 156 | -2.4 Number of liquid/very soft stools/day | Standard Deviation 3.14 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 96 | -2.2 Number of liquid/very soft stools/day | Standard Deviation 3.11 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 48 | -2.0 Number of liquid/very soft stools/day | Standard Deviation 3.14 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 24 | -1.8 Number of liquid/very soft stools/day | Standard Deviation 2.89 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 216 | -2.8 Number of liquid/very soft stools/day | Standard Deviation 3.17 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 300 | 0.0 Number of liquid/very soft stools/day | Standard Deviation 2.71 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline | 4.0 Number of liquid/very soft stools/day | Standard Deviation 3.12 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 48 | -0.8 Number of liquid/very soft stools/day | Standard Deviation 2.49 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 96 | -0.7 Number of liquid/very soft stools/day | Standard Deviation 2.7 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 264 | -4.8 Number of liquid/very soft stools/day | Standard Deviation 6.18 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 12 | -0.7 Number of liquid/very soft stools/day | Standard Deviation 2.01 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 24 | -0.7 Number of liquid/very soft stools/day | Standard Deviation 2.59 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 156 | -0.7 Number of liquid/very soft stools/day | Standard Deviation 3.19 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 216 | -1.2 Number of liquid/very soft stools/day | Standard Deviation 4.1 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 12 | 0.2 Number of liquid/very soft stools/day | Standard Deviation 1.44 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 216 | 1.0 Number of liquid/very soft stools/day | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 156 | -0.2 Number of liquid/very soft stools/day | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 24 | 0.1 Number of liquid/very soft stools/day | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline | 2.2 Number of liquid/very soft stools/day | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 48 | 0.0 Number of liquid/very soft stools/day | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Change at Week 96 | 0.4 Number of liquid/very soft stools/day | Standard Deviation 2.79 |
Secondary
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline in abdominal pain was reported.
Time frame: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Population: Participants from safety analysis set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 156 | -0.8 units on a scale | Standard Deviation 0.98 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 24 | -0.7 units on a scale | Standard Deviation 0.92 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline | 1.6 units on a scale | Standard Deviation 0.91 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 48 | -0.8 units on a scale | Standard Deviation 0.97 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 300 | -0.3 units on a scale | Standard Deviation 0.5 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 216 | -0.9 units on a scale | Standard Deviation 1.05 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 12 | -0.6 units on a scale | Standard Deviation 0.91 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 96 | -0.8 units on a scale | Standard Deviation 1 |
| Filgotinib 200 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 264 | -0.8 units on a scale | Standard Deviation 0.64 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 264 | -1.3 units on a scale | Standard Deviation 0.5 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 12 | -0.2 units on a scale | Standard Deviation 0.65 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 24 | -0.2 units on a scale | Standard Deviation 0.75 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 96 | -0.2 units on a scale | Standard Deviation 0.73 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 156 | -0.2 units on a scale | Standard Deviation 0.77 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 216 | -0.5 units on a scale | Standard Deviation 0.88 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline | 1.0 units on a scale | Standard Deviation 0.89 |
| Filgotinib 100 mg | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 48 | -0.3 units on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 216 | 0.0 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline | 0.7 units on a scale | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 96 | 0.0 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 156 | 0.0 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 48 | -0.1 units on a scale | Standard Deviation 0.54 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 12 | 0.0 units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Change at Week 24 | 0.0 units on a scale | Standard Deviation 0.51 |