Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy (NCT NCT04115748)
NCT ID: NCT04115748
Last Updated: 2022-05-16
Results Overview
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Week 12
Results posted on
2022-05-16
Participant Flow
Participants were enrolled at study sites in Poland, the United States, Bulgaria, Spain, Australia, Japan, New Zealand, and Canada. The first participant was screened on 03 December 2019. The last study visit occurred on 11 May 2021.
161 participants were screened.
Participant milestones
| Measure |
Filgotinib 200 mg (Main Study)
Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab 40 mg (Main Study)
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
Long term extension (LTE):
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
|
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
|
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 200 mg From Placebo (LTE)
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
Filgotinib 100 mg From Placebo (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study (Up to 16 Weeks)
STARTED
|
19
|
19
|
9
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Up to 16 Weeks)
COMPLETED
|
4
|
3
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Up to 16 Weeks)
NOT COMPLETED
|
15
|
16
|
7
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After 16 Weeks to Week 50)
STARTED
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
1
|
2
|
2
|
|
LTE (After 16 Weeks to Week 50)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After 16 Weeks to Week 50)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Filgotinib 200 mg (Main Study)
Filgotinib 200 milligrams (mg) tablet orally once daily + placebo to match (PTM) filgotinib 100 mg tablet orally once daily + PTM adalimumab subcutaneous (SC) injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab 40 mg (Main Study)
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
Long term extension (LTE):
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
|
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
|
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 200 mg From Placebo (LTE)
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
Filgotinib 100 mg From Placebo (LTE)
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Main Study (Up to 16 Weeks)
Study terminated by sponsor
|
15
|
16
|
7
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study (Up to 16 Weeks)
Withdrew consent
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After 16 Weeks to Week 50)
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
1
|
1
|
2
|
|
LTE (After 16 Weeks to Week 50)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
Baseline characteristics by cohort
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab 40 mg (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
46 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
50 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
47 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
47 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study drug.
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
|
76.8 percentage of participants
Interval 57.2 to 96.5
|
63.2 percentage of participants
Interval 38.8 to 87.5
|
67.2 percentage of participants
Interval 36.2 to 98.3
|
44.8 percentage of participants
Interval 22.8 to 66.7
|
SECONDARY outcome
Timeframe: Baseline, 4, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\];36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\];TJC68;SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\];Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\];C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
Baseline
|
5.9 score on a scale
Standard Deviation 1.32
|
5.3 score on a scale
Standard Deviation 0.99
|
5.5 score on a scale
Standard Deviation 1.05
|
5.5 score on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
Change From Baseline at Week 4
|
-1.5 score on a scale
Standard Deviation 0.62
|
-1.0 score on a scale
Standard Deviation 0.99
|
-1.3 score on a scale
Standard Deviation 0.66
|
-0.3 score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
Change From Baseline at Week 16
|
-2.5 score on a scale
Standard Deviation 1.26
|
-2.0 score on a scale
Standard Deviation 1.48
|
-2.6 score on a scale
Standard Deviation 1.37
|
-1.0 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; patient's global assessment of PsA pain intensity (PGAPI) ≤15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 for participants with enthesitis at baseline.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
Week 4
|
21.1 percentage of participants
Interval 0.1 to 42.0
|
16.7 percentage of participants
Interval 0.0 to 36.7
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
5.0 percentage of participants
Interval 0.0 to 17.1
|
|
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
Week 8
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
15.8 percentage of participants
Interval 0.0 to 34.8
|
|
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
Week 12
|
44.4 percentage of participants
Interval 18.7 to 70.2
|
47.4 percentage of participants
Interval 22.3 to 72.5
|
37.5 percentage of participants
Interval 0.0 to 77.3
|
15.8 percentage of participants
Interval 0.0 to 34.8
|
|
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
Week 16
|
27.8 percentage of participants
Interval 4.3 to 51.2
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
37.5 percentage of participants
Interval 0.0 to 77.3
|
20.0 percentage of participants
Interval 0.0 to 40.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; PGAPI ≤15 \[using VAS on a scale of 0 (no pain) to (serious pain)\]; PGADA ≤20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤0.5; LEI score ≤1 with participants with enthesitis at baseline.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
Week 4
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 5.6
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
Week 8
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 5.6
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
Week 12
|
11.1 percentage of participants
Interval 0.0 to 28.4
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
|
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
Week 16
|
5.6 percentage of participants
Interval 0.0 to 18.9
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
11.1 percentage of participants
Interval 0.0 to 37.2
|
0 percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-19.3 score on a scale
Standard Deviation 14.30
|
-9.4 score on a scale
Standard Deviation 12.13
|
-14.2 score on a scale
Standard Deviation 10.45
|
-6.5 score on a scale
Standard Deviation 8.41
|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-27.4 score on a scale
Standard Deviation 17.09
|
-18.0 score on a scale
Standard Deviation 11.00
|
-25.2 score on a scale
Standard Deviation 16.60
|
-9.3 score on a scale
Standard Deviation 9.81
|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Baseline
|
48.0 score on a scale
Standard Deviation 25.55
|
30.3 score on a scale
Standard Deviation 10.43
|
38.8 score on a scale
Standard Deviation 20.82
|
33.8 score on a scale
Standard Deviation 17.55
|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-12.5 score on a scale
Standard Deviation 11.96
|
-5.3 score on a scale
Standard Deviation 9.12
|
-10.9 score on a scale
Standard Deviation 8.39
|
-7.5 score on a scale
Standard Deviation 11.72
|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-28.4 score on a scale
Standard Deviation 15.67
|
-12.4 score on a scale
Standard Deviation 11.06
|
-17.8 score on a scale
Standard Deviation 12.96
|
-10.6 score on a scale
Standard Deviation 8.87
|
|
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-28.1 score on a scale
Standard Deviation 13.42
|
-17.4 score on a scale
Standard Deviation 12.16
|
-25.1 score on a scale
Standard Deviation 14.55
|
-11.3 score on a scale
Standard Deviation 12.18
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Baseline
|
3 score on a scale
Standard Deviation 1.2
|
2 score on a scale
Standard Deviation 0.8
|
2 score on a scale
Standard Deviation 0.5
|
2 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Change From Baseline at Week 2
|
-1 score on a scale
Standard Deviation 0.5
|
0 score on a scale
Standard Deviation 0.0
|
0 score on a scale
Standard Deviation 0.5
|
0 score on a scale
Standard Deviation 0.0
|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Change From Baseline at Week 4
|
-1 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0.5
|
-1 score on a scale
Standard Deviation 1.0
|
0 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Change From Baseline at Week 8
|
-1 score on a scale
Standard Deviation 1.0
|
-1 score on a scale
Standard Deviation 0.7
|
-1 score on a scale
Standard Deviation 0.8
|
-1 score on a scale
Standard Deviation 1.0
|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Change From Baseline at Week 12
|
-1 score on a scale
Standard Deviation 1.3
|
-1 score on a scale
Standard Deviation 1.1
|
-2 score on a scale
Standard Deviation 0.6
|
0 score on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
Change From Baseline at Week 16
|
-1 score on a scale
Standard Deviation 0.7
|
-1 score on a scale
Standard Deviation 0.8
|
-2 score on a scale
Standard Deviation 0.6
|
-1 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with psoriatic nail involvement at baseline and with available data were analyzed.
mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=9 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=11 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=6 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=13 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
Baseline
|
19 score on a scale
Standard Deviation 15.1
|
15 score on a scale
Standard Deviation 12.9
|
24 score on a scale
Standard Deviation 32.3
|
14 score on a scale
Standard Deviation 12.9
|
|
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
Change From Baseline at Week 4
|
-3 score on a scale
Standard Deviation 3.5
|
1 score on a scale
Standard Deviation 4.5
|
-3 score on a scale
Standard Deviation 10.0
|
0 score on a scale
Standard Deviation 8.2
|
|
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
Change From Baseline at Week 8
|
-3 score on a scale
Standard Deviation 5.1
|
-1 score on a scale
Standard Deviation 5.9
|
-6 score on a scale
Standard Deviation 19.4
|
-2 score on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
Change From Baseline at Week 12
|
-4 score on a scale
Standard Deviation 6.0
|
0 score on a scale
Standard Deviation 5.4
|
-9 score on a scale
Standard Deviation 23.2
|
-3 score on a scale
Standard Deviation 10.6
|
|
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
Change From Baseline at Week 16
|
0 score on a scale
Standard Deviation 10.8
|
-3 score on a scale
Standard Deviation 9.6
|
-14 score on a scale
Standard Deviation 23.7
|
-2 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=10 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=9 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=6 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=11 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Baseline
|
2 score on a scale
Standard Deviation 1.6
|
2 score on a scale
Standard Deviation 1.4
|
2 score on a scale
Standard Deviation 1.4
|
2 score on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 8
|
-1 score on a scale
Standard Deviation 0.8
|
-1 score on a scale
Standard Deviation 1.2
|
-2 score on a scale
Standard Deviation 1.5
|
0 score on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 4
|
-1 score on a scale
Standard Deviation 0.8
|
0 score on a scale
Standard Deviation 0.7
|
-1 score on a scale
Standard Deviation 1.1
|
0 score on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 12
|
-1 score on a scale
Standard Deviation 1.4
|
-1 score on a scale
Standard Deviation 1.6
|
-2 score on a scale
Standard Deviation 1.8
|
0 score on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 16
|
-1 score on a scale
Standard Deviation 1.2
|
-1 score on a scale
Standard Deviation 1.5
|
-2 score on a scale
Standard Deviation 1.6
|
0 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 4, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
Baseline
|
4.82 score on a scale
Standard Deviation 1.857
|
4.46 score on a scale
Standard Deviation 2.115
|
5.28 score on a scale
Standard Deviation 1.765
|
4.44 score on a scale
Standard Deviation 2.071
|
|
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
Change From Baseline at Week 4
|
-1.71 score on a scale
Standard Deviation 1.282
|
-1.39 score on a scale
Standard Deviation 1.214
|
-1.73 score on a scale
Standard Deviation 1.645
|
-0.10 score on a scale
Standard Deviation 1.520
|
|
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
Change From Baseline at Week 16
|
-2.06 score on a scale
Standard Deviation 1.314
|
-2.04 score on a scale
Standard Deviation 1.740
|
-2.56 score on a scale
Standard Deviation 2.062
|
-0.52 score on a scale
Standard Deviation 2.176
|
SECONDARY outcome
Timeframe: Weeks 4, and 16Population: Participants in the FAS with available data were analyzed.
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS LDA is defined as PASDAS ≤ 3.2.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
Week 16
|
38.9 percentage of participants
Interval 13.6 to 64.2
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
50.0 percentage of participants
Interval 9.1 to 90.9
|
15.0 percentage of participants
Interval 0.0 to 33.1
|
|
Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
Week 4
|
21.1 percentage of participants
Interval 0.1 to 42.0
|
11.1 percentage of participants
Interval 0.0 to 28.4
|
0 percentage of participants
Interval 0.0 to 6.3
|
5.0 percentage of participants
Interval 0.0 to 17.1
|
SECONDARY outcome
Timeframe: Weeks 4, and 16Population: Participants in the FAS with available data were analyzed.
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\];TJC68;SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis\]; Tender dactylitis count (TDC) \[with a score range of 0 to 60, higher score indicates higher degree of dactylitis\]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS remission is defined as PASDAS ≤ 1.9.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
Week 16
|
16.7 percentage of participants
Interval 0.0 to 36.7
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
5.0 percentage of participants
Interval 0.0 to 17.1
|
|
Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
Week 4
|
0 percentage of participants
Interval 0.0 to 2.6
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 16
|
88.9 percentage of participants
Interval 71.6 to 100.0
|
52.6 percentage of participants
Interval 27.5 to 77.7
|
77.8 percentage of participants
Interval 45.1 to 100.0
|
45.0 percentage of participants
Interval 20.7 to 69.3
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 2
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
5.6 percentage of participants
Interval 0.0 to 18.9
|
11.1 percentage of participants
Interval 0.0 to 37.2
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 4
|
52.6 percentage of participants
Interval 27.5 to 77.7
|
27.8 percentage of participants
Interval 4.3 to 51.2
|
33.3 percentage of participants
Interval 0.0 to 69.7
|
10.0 percentage of participants
Interval 0.0 to 25.6
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 8
|
73.7 percentage of participants
Interval 51.3 to 96.1
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
55.6 percentage of participants
Interval 17.5 to 93.6
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 12
|
77.8 percentage of participants
Interval 55.8 to 99.8
|
63.2 percentage of participants
Interval 38.8 to 87.5
|
75.0 percentage of participants
Interval 38.7 to 100.0
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 8
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
11.1 percentage of participants
Interval 0.0 to 37.2
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 12
|
55.6 percentage of participants
Interval 29.8 to 81.3
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
37.5 percentage of participants
Interval 0.0 to 77.3
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 16
|
27.8 percentage of participants
Interval 4.3 to 51.2
|
47.4 percentage of participants
Interval 22.3 to 72.5
|
33.3 percentage of participants
Interval 0.0 to 69.7
|
15.0 percentage of participants
Interval 0.0 to 33.1
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 2
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 5.6
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 4
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
5.6 percentage of participants
Interval 0.0 to 18.9
|
0 percentage of participants
Interval 0.0 to 5.6
|
5.0 percentage of participants
Interval 0.0 to 17.1
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 4
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 5.6
|
0 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 8
|
15.8 percentage of participants
Interval 0.0 to 34.8
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
0 percentage of participants
Interval 0.0 to 5.6
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 16
|
22.2 percentage of participants
Interval 0.2 to 44.2
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
10.0 percentage of participants
Interval 0.0 to 25.6
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 2
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 5.6
|
0 percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Week 12
|
27.8 percentage of participants
Interval 4.3 to 51.2
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
0 percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Baseline
|
22 tender joint count
Standard Deviation 14.9
|
13 tender joint count
Standard Deviation 8.5
|
17 tender joint count
Standard Deviation 11.0
|
14 tender joint count
Standard Deviation 11.6
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-14 tender joint count
Standard Deviation 7.7
|
-7 tender joint count
Standard Deviation 7.9
|
-10 tender joint count
Standard Deviation 6.1
|
-5 tender joint count
Standard Deviation 8.3
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-6 tender joint count
Standard Deviation 8.7
|
-1 tender joint count
Standard Deviation 5.2
|
-5 tender joint count
Standard Deviation 3.9
|
-3 tender joint count
Standard Deviation 6.6
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-9 tender joint count
Standard Deviation 10.3
|
-3 tender joint count
Standard Deviation 7.9
|
-7 tender joint count
Standard Deviation 5.3
|
-3 tender joint count
Standard Deviation 4.6
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-13 tender joint count
Standard Deviation 9.9
|
-5 tender joint count
Standard Deviation 6.3
|
-7 tender joint count
Standard Deviation 7.4
|
-4 tender joint count
Standard Deviation 4.8
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-13 tender joint count
Standard Deviation 7.4
|
-7 tender joint count
Standard Deviation 7.4
|
-10 tender joint count
Standard Deviation 8.5
|
-4 tender joint count
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Baseline
|
14 swollen joint count
Standard Deviation 10.3
|
7 swollen joint count
Standard Deviation 3.3
|
11 swollen joint count
Standard Deviation 7.3
|
8 swollen joint count
Standard Deviation 5.9
|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-3 swollen joint count
Standard Deviation 3.8
|
-1 swollen joint count
Standard Deviation 3.5
|
-5 swollen joint count
Standard Deviation 5.2
|
-2 swollen joint count
Standard Deviation 4.7
|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-5 swollen joint count
Standard Deviation 6.2
|
-2 swollen joint count
Standard Deviation 2.9
|
-4 swollen joint count
Standard Deviation 7.0
|
-2 swollen joint count
Standard Deviation 3.1
|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-9 swollen joint count
Standard Deviation 7.0
|
-3 swollen joint count
Standard Deviation 4.0
|
-6 swollen joint count
Standard Deviation 6.1
|
-3 swollen joint count
Standard Deviation 2.9
|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-8 swollen joint count
Standard Deviation 8.9
|
-4 swollen joint count
Standard Deviation 3.1
|
-8 swollen joint count
Standard Deviation 7.3
|
-4 swollen joint count
Standard Deviation 2.9
|
|
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-8 swollen joint count
Standard Deviation 7.9
|
-4 swollen joint count
Standard Deviation 3.8
|
-8 swollen joint count
Standard Deviation 6.7
|
-4 swollen joint count
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Baseline
|
54 score on a scale
Standard Deviation 26.0
|
58 score on a scale
Standard Deviation 22.8
|
47 score on a scale
Standard Deviation 24.2
|
52 score on a scale
Standard Deviation 24.0
|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-15 score on a scale
Standard Deviation 17.8
|
-17 score on a scale
Standard Deviation 26.6
|
3 score on a scale
Standard Deviation 8.6
|
-10 score on a scale
Standard Deviation 12.6
|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-23 score on a scale
Standard Deviation 20.3
|
-23 score on a scale
Standard Deviation 32.2
|
-3 score on a scale
Standard Deviation 11.4
|
-4 score on a scale
Standard Deviation 16.6
|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-24 score on a scale
Standard Deviation 22.6
|
-28 score on a scale
Standard Deviation 33.8
|
-4 score on a scale
Standard Deviation 17.1
|
-16 score on a scale
Standard Deviation 23.4
|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-27 score on a scale
Standard Deviation 25.9
|
-38 score on a scale
Standard Deviation 29.9
|
-29 score on a scale
Standard Deviation 19.7
|
-9 score on a scale
Standard Deviation 24.7
|
|
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-31 score on a scale
Standard Deviation 26.4
|
-34 score on a scale
Standard Deviation 28.5
|
-25 score on a scale
Standard Deviation 25.3
|
-12 score on a scale
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-36 score on a scale
Standard Deviation 18.8
|
-26 score on a scale
Standard Deviation 22.4
|
-42 score on a scale
Standard Deviation 20.8
|
-21 score on a scale
Standard Deviation 21.8
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-37 score on a scale
Standard Deviation 16.4
|
-27 score on a scale
Standard Deviation 21.6
|
-44 score on a scale
Standard Deviation 21.0
|
-19 score on a scale
Standard Deviation 20.2
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Baseline
|
68 score on a scale
Standard Deviation 16.4
|
56 score on a scale
Standard Deviation 14.3
|
65 score on a scale
Standard Deviation 13.1
|
62 score on a scale
Standard Deviation 13.4
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-17 score on a scale
Standard Deviation 12.3
|
-4 score on a scale
Standard Deviation 11.0
|
-12 score on a scale
Standard Deviation 9.2
|
-8 score on a scale
Standard Deviation 9.8
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-23 score on a scale
Standard Deviation 14.5
|
-12 score on a scale
Standard Deviation 18.6
|
-29 score on a scale
Standard Deviation 14.8
|
-8 score on a scale
Standard Deviation 11.5
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-35 score on a scale
Standard Deviation 15.1
|
-17 score on a scale
Standard Deviation 17.4
|
-35 score on a scale
Standard Deviation 13.6
|
-21 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Baseline
|
60 score on a scale
Standard Deviation 24.7
|
45 score on a scale
Standard Deviation 22.3
|
48 score on a scale
Standard Deviation 24.3
|
56 score on a scale
Standard Deviation 24.2
|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-16 score on a scale
Standard Deviation 15.2
|
-4 score on a scale
Standard Deviation 16.7
|
-5 score on a scale
Standard Deviation 9.5
|
-8 score on a scale
Standard Deviation 11.5
|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-24 score on a scale
Standard Deviation 20.9
|
-13 score on a scale
Standard Deviation 18.6
|
-10 score on a scale
Standard Deviation 9.8
|
-1 score on a scale
Standard Deviation 14.3
|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-33 score on a scale
Standard Deviation 20.9
|
-13 score on a scale
Standard Deviation 23.4
|
-3 score on a scale
Standard Deviation 17.3
|
-11 score on a scale
Standard Deviation 25.3
|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-33 score on a scale
Standard Deviation 23.7
|
-19 score on a scale
Standard Deviation 21.0
|
-28 score on a scale
Standard Deviation 20.7
|
-8 score on a scale
Standard Deviation 23.3
|
|
Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-29 score on a scale
Standard Deviation 24.5
|
-17 score on a scale
Standard Deviation 26.5
|
-27 score on a scale
Standard Deviation 15.2
|
-12 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Baseline
|
8.08 mg/L
Standard Deviation 9.335
|
3.14 mg/L
Standard Deviation 2.673
|
10.56 mg/L
Standard Deviation 16.354
|
7.11 mg/L
Standard Deviation 9.727
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-6.37 mg/L
Standard Deviation 8.518
|
-0.10 mg/L
Standard Deviation 5.313
|
-7.70 mg/L
Standard Deviation 11.874
|
0.50 mg/L
Standard Deviation 4.063
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-6.68 mg/L
Standard Deviation 8.998
|
-0.95 mg/L
Standard Deviation 2.564
|
-5.99 mg/L
Standard Deviation 8.981
|
3.96 mg/L
Standard Deviation 13.594
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-5.13 mg/L
Standard Deviation 11.271
|
-0.69 mg/L
Standard Deviation 4.474
|
-6.40 mg/L
Standard Deviation 9.740
|
-1.15 mg/L
Standard Deviation 4.979
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-6.04 mg/L
Standard Deviation 8.518
|
-1.11 mg/L
Standard Deviation 3.161
|
-3.80 mg/L
Standard Deviation 7.334
|
2.25 mg/L
Standard Deviation 7.788
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-5.88 mg/L
Standard Deviation 9.195
|
-0.47 mg/L
Standard Deviation 5.496
|
-6.80 mg/L
Standard Deviation 10.918
|
1.05 mg/L
Standard Deviation 5.623
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-0.9 score on a scale
Standard Deviation 0.62
|
-0.5 score on a scale
Standard Deviation 0.74
|
-0.9 score on a scale
Standard Deviation 0.70
|
-0.6 score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Baseline
|
4.9 score on a scale
Standard Deviation 1.27
|
4.2 score on a scale
Standard Deviation 0.78
|
4.5 score on a scale
Standard Deviation 0.97
|
4.4 score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-1.9 score on a scale
Standard Deviation 0.96
|
-1.5 score on a scale
Standard Deviation 0.89
|
-1.9 score on a scale
Standard Deviation 0.88
|
-0.8 score on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-1.2 score on a scale
Standard Deviation 0.63
|
-0.9 score on a scale
Standard Deviation 1.04
|
-1.2 score on a scale
Standard Deviation 0.60
|
-0.5 score on a scale
Standard Deviation 0.65
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-1.8 score on a scale
Standard Deviation 0.87
|
-1.2 score on a scale
Standard Deviation 0.71
|
-1.2 score on a scale
Standard Deviation 0.83
|
-1.0 score on a scale
Standard Deviation 0.66
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-1.8 score on a scale
Standard Deviation 0.62
|
-1.8 score on a scale
Standard Deviation 0.97
|
-2.0 score on a scale
Standard Deviation 0.71
|
-0.8 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) ≤ 3.2.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Week 4
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
44.4 percentage of participants
Interval 18.7 to 70.2
|
55.6 percentage of participants
Interval 17.5 to 93.6
|
25.0 percentage of participants
Interval 3.5 to 46.5
|
|
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Week 8
|
63.2 percentage of participants
Interval 38.8 to 87.5
|
63.2 percentage of participants
Interval 38.8 to 87.5
|
33.3 percentage of participants
Interval 0.0 to 69.7
|
52.6 percentage of participants
Interval 27.5 to 77.7
|
|
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Week 2
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
33.3 percentage of participants
Interval 8.8 to 57.9
|
33.3 percentage of participants
Interval 0.0 to 69.7
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
|
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Week 12
|
66.7 percentage of participants
Interval 42.1 to 91.2
|
68.4 percentage of participants
Interval 44.9 to 92.0
|
62.5 percentage of participants
Interval 22.7 to 100.0
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
|
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Week 16
|
50.0 percentage of participants
Interval 24.1 to 75.9
|
84.2 percentage of participants
Interval 65.2 to 100.0
|
66.7 percentage of participants
Interval 30.3 to 100.0
|
45.0 percentage of participants
Interval 20.7 to 69.3
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) \< 2.6.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
Week 2
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
11.1 percentage of participants
Interval 0.0 to 28.4
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
Week 4
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
27.8 percentage of participants
Interval 4.3 to 51.2
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
15.0 percentage of participants
Interval 0.0 to 33.1
|
|
Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
Week 8
|
47.4 percentage of participants
Interval 22.3 to 72.5
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
26.3 percentage of participants
Interval 3.9 to 48.7
|
|
Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
Week 12
|
55.6 percentage of participants
Interval 29.8 to 81.3
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
50.0 percentage of participants
Interval 9.1 to 90.9
|
21.1 percentage of participants
Interval 0.1 to 42.0
|
|
Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
Week 16
|
44.4 percentage of participants
Interval 18.7 to 70.2
|
52.6 percentage of participants
Interval 27.5 to 77.7
|
44.4 percentage of participants
Interval 6.4 to 82.5
|
20.0 percentage of participants
Interval 0.0 to 40.0
|
SECONDARY outcome
Timeframe: Up to 19 weeksPopulation: Participants in the FAS with available data were analyzed.
The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) ≤ 3.2. Time to achieve DAS28 (CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28 (CRP) LDA.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=18 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=17 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=7 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=17 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Time to Achieve DAS28 (CRP) LDA
|
57 days
Interval 17.0 to
Upper bound of 95% CI was not estimable due to low number of participants with DAS28 (CRP) LDA.
|
58 days
Interval 16.0 to 113.0
|
29 days
Interval 14.0 to 127.0
|
59 days
Interval 15.0 to
Upper bound of 95% CI was not estimable due to low number of participants with DAS28 (CRP) LDA.
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA LDA is defined as DAPSA ≤ 14.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Week 2
|
15.8 percentage of participants
Interval 0.0 to 34.8
|
11.1 percentage of participants
Interval 0.0 to 28.4
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
|
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Week 4
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
38.9 percentage of participants
Interval 13.6 to 64.2
|
44.4 percentage of participants
Interval 6.4 to 82.5
|
25.0 percentage of participants
Interval 3.5 to 46.5
|
|
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Week 8
|
52.6 percentage of participants
Interval 27.5 to 77.7
|
42.1 percentage of participants
Interval 17.3 to 66.9
|
33.3 percentage of participants
Interval 0.0 to 69.7
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
|
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Week 12
|
61.1 percentage of participants
Interval 35.8 to 86.4
|
57.9 percentage of participants
Interval 33.1 to 82.7
|
62.5 percentage of participants
Interval 22.7 to 100.0
|
36.8 percentage of participants
Interval 12.5 to 61.2
|
|
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Week 16
|
44.4 percentage of participants
Interval 18.7 to 70.2
|
63.2 percentage of participants
Interval 38.8 to 87.5
|
55.6 percentage of participants
Interval 17.5 to 93.6
|
40.0 percentage of participants
Interval 16.0 to 64.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA remission is defined as DAPSA ≤ 4.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Week 2
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 2.8
|
0 percentage of participants
Interval 0.0 to 5.6
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
|
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Week 4
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
5.6 percentage of participants
Interval 0.0 to 18.9
|
0 percentage of participants
Interval 0.0 to 5.6
|
5.0 percentage of participants
Interval 0.0 to 17.1
|
|
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Week 8
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
0 percentage of participants
Interval 0.0 to 5.6
|
10.5 percentage of participants
Interval 0.0 to 27.0
|
|
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Week 12
|
22.2 percentage of participants
Interval 0.2 to 44.2
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
5.3 percentage of participants
Interval 0.0 to 17.9
|
|
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Week 16
|
16.7 percentage of participants
Interval 0.0 to 36.7
|
21.1 percentage of participants
Interval 0.1 to 42.0
|
22.2 percentage of participants
Interval 0.0 to 54.9
|
10.0 percentage of participants
Interval 0.0 to 25.6
|
SECONDARY outcome
Timeframe: Up to 19 weeksPopulation: Participants in the FAS with available data were analyzed.
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA. If the DAPSA LDA is not achieved during main study phase, the time to achieve DAPSA LDA will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores of DAPSA LDA are at different dates for a visit, the latest date will be used for the derivation of time to achieve DAPSA LDA.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=18 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=18 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=7 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=18 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Time to Achieve DAPSA LDA
|
73 days
Interval 31.0 to
Upper bound of 95% CI was not estimable due to the low number of participants with DAPSA LDA.
|
82 days
Interval 29.0 to
Upper bound of 95% CI was not estimable due to the low number of participants with DAPSA LDA.
|
83 days
Interval 15.0 to 127.0
|
NA days
Interval 16.0 to
Median and Upper bound of 95% CI were not estimable due to the low number of participants with DAPSA LDA.
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 16Population: Participants in the FAS with available data were analyzed.
The PsARC response is defined as improvement in at least 2 of the following 4 criteria; ≥ 30% decrease in SJC66, ≥ 30% decrease in TJC68, ≥ 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), ≥ 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity), and with at least one of the 2 joint criteria, with no deterioration in any other criteria.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=9 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Week 2
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
16.7 percentage of participants
Interval 0.0 to 36.7
|
11.1 percentage of participants
Interval 0.0 to 37.2
|
31.6 percentage of participants
Interval 8.0 to 55.1
|
|
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Week 4
|
57.9 percentage of participants
Interval 33.1 to 82.7
|
38.9 percentage of participants
Interval 13.6 to 64.2
|
44.4 percentage of participants
Interval 6.4 to 82.5
|
30.0 percentage of participants
Interval 7.4 to 52.6
|
|
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Week 8
|
78.9 percentage of participants
Interval 58.0 to 99.9
|
47.4 percentage of participants
Interval 22.3 to 72.5
|
44.4 percentage of participants
Interval 6.4 to 82.5
|
57.9 percentage of participants
Interval 33.1 to 82.7
|
|
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Week 12
|
72.2 percentage of participants
Interval 48.8 to 95.7
|
68.4 percentage of participants
Interval 44.9 to 92.0
|
75.0 percentage of participants
Interval 38.7 to 100.0
|
47.4 percentage of participants
Interval 22.3 to 72.5
|
|
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Week 16
|
88.9 percentage of participants
Interval 71.6 to 100.0
|
57.9 percentage of participants
Interval 33.1 to 82.7
|
77.8 percentage of participants
Interval 45.1 to 100.0
|
45.0 percentage of participants
Interval 20.7 to 69.3
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Baseline
|
9.5 score on a scale
Standard Deviation 6.70
|
13.8 score on a scale
Standard Deviation 14.12
|
6.5 score on a scale
Standard Deviation 5.90
|
9.6 score on a scale
Standard Deviation 10.60
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Change From Baseline at Week 4
|
-2.2 score on a scale
Standard Deviation 5.19
|
-5.0 score on a scale
Standard Deviation 5.14
|
-1.8 score on a scale
Standard Deviation 1.54
|
-1.1 score on a scale
Standard Deviation 5.41
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Change From Baseline at Week 8
|
-3.4 score on a scale
Standard Deviation 4.91
|
-5.5 score on a scale
Standard Deviation 4.93
|
-3.0 score on a scale
Standard Deviation 1.98
|
-5.6 score on a scale
Standard Deviation 7.03
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Change From Baseline at Week 12
|
-3.7 score on a scale
Standard Deviation 5.65
|
-5.6 score on a scale
Standard Deviation 6.13
|
-3.0 score on a scale
Standard Deviation 2.10
|
-4.9 score on a scale
Standard Deviation 7.12
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Change From Baseline at Week 16
|
-5.5 score on a scale
Standard Deviation 7.80
|
-7.0 score on a scale
Standard Deviation 7.69
|
-5.2 score on a scale
Standard Deviation 4.56
|
-6.4 score on a scale
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 12
|
57.1 percentage of participants
Interval 13.3 to 100.0
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
100.0 percentage of participants
Interval 83.3 to 100.0
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 4
|
37.5 percentage of participants
Interval 0.0 to 77.3
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 8
|
25.0 percentage of participants
Interval 0.0 to 61.3
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 16
|
62.5 percentage of participants
Interval 22.7 to 100.0
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
100.0 percentage of participants
Interval 87.5 to 100.0
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 12
|
42.9 percentage of participants
Interval 0.0 to 86.7
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
66.7 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 16
|
62.5 percentage of participants
Interval 22.7 to 100.0
|
20.0 percentage of participants
Interval 0.0 to 65.1
|
75.0 percentage of participants
Interval 20.1 to 100.0
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 4
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
20.0 percentage of participants
Interval 0.0 to 65.1
|
0 percentage of participants
Interval 0.0 to 12.5
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 8
|
25.0 percentage of participants
Interval 0.0 to 61.3
|
40.0 percentage of participants
Interval 0.0 to 92.9
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
0 percentage of participants
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 4
|
0 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 8
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
0 percentage of participants
Interval 0.0 to 10.0
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 12
|
14.3 percentage of participants
Interval 0.0 to 47.4
|
20.0 percentage of participants
Interval 0.0 to 65.1
|
66.7 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 16
|
25.0 percentage of participants
Interval 0.0 to 61.3
|
20.0 percentage of participants
Interval 0.0 to 65.1
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 16Population: Participants in the FAS with psoriasis covering ≥ 3% of the BSA at baseline and with available data were analyzed.
PASI is assessed in participants with psoriasis covering ≥ 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=8 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=5 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=4 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 16
|
12.5 percentage of participants
Interval 0.0 to 41.7
|
20.0 percentage of participants
Interval 0.0 to 65.1
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 4
|
0 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 8
|
0 percentage of participants
Interval 0.0 to 6.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
25.0 percentage of participants
Interval 0.0 to 79.9
|
0 percentage of participants
Interval 0.0 to 12.5
|
|
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
Week 12
|
14.3 percentage of participants
Interval 0.0 to 47.4
|
0 percentage of participants
Interval 0.0 to 10.0
|
66.7 percentage of participants
Interval 0.0 to 100.0
|
0 percentage of participants
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with enthesitis at baseline and with available data were analyzed.
The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=10 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=9 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=6 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=11 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 12
|
-3 score on a scale
Standard Deviation 3.5
|
-2 score on a scale
Standard Deviation 1.8
|
-2 score on a scale
Standard Deviation 1.5
|
-1 score on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Baseline
|
4 score on a scale
Standard Deviation 3.4
|
4 score on a scale
Standard Deviation 2.4
|
4 score on a scale
Standard Deviation 1.7
|
5 score on a scale
Standard Deviation 4.5
|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 4
|
-2 score on a scale
Standard Deviation 2.6
|
0 score on a scale
Standard Deviation 2.0
|
-2 score on a scale
Standard Deviation 1.2
|
0 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 8
|
-2 score on a scale
Standard Deviation 2.4
|
-1 score on a scale
Standard Deviation 1.6
|
-3 score on a scale
Standard Deviation 1.9
|
-2 score on a scale
Standard Deviation 3.3
|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Change From Baseline at Week 16
|
-3 score on a scale
Standard Deviation 3.3
|
-2 score on a scale
Standard Deviation 2.6
|
-3 score on a scale
Standard Deviation 1.5
|
-1 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with dactylitis at baseline were analyzed.
LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit (digit on opposite hand or foot), or if contralateral digit is also affected, values from a standard reference table. Total score= {{\[Circumference involved digit/ Circumference contralateral Digit (or Tables)\] - 1}x 100} x Tenderness score. Tenderness score (0 = no tenderness, and 1 = tender). The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=6 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=3 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=1 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=5 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Baseline
|
69.5 score on a scale
Standard Deviation 56.62
|
28.9 score on a scale
Standard Deviation 17.35
|
159.1 score on a scale
Standard Deviation NA
Standard deviation (SD) cannot be calculated for 1 participant.
|
15.2 score on a scale
Standard Deviation 19.45
|
|
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 4
|
-13.4 score on a scale
Standard Deviation 16.81
|
13.0 score on a scale
Standard Deviation 19.44
|
-159.1 score on a scale
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
13.3 score on a scale
Standard Deviation 30.64
|
|
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 8
|
-40.8 score on a scale
Standard Deviation 45.15
|
-2.5 score on a scale
Standard Deviation 18.34
|
-159.1 score on a scale
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
3.6 score on a scale
Standard Deviation 40.81
|
|
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 12
|
-49.3 score on a scale
Standard Deviation 40.86
|
-14.0 score on a scale
Standard Deviation 9.80
|
-159.1 score on a scale
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
2.1 score on a scale
Standard Deviation 44.13
|
|
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 16
|
-40.2 score on a scale
Standard Deviation 51.12
|
8.4 score on a scale
Standard Deviation 41.91
|
-159.1 score on a scale
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
2.0 score on a scale
Standard Deviation 31.30
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with dactylitis at baseline were analyzed.
Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score \>0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=6 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=3 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=1 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=5 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Baseline
|
4 tender dactylitis count
Standard Deviation 4.1
|
2 tender dactylitis count
Standard Deviation 1.0
|
6 tender dactylitis count
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
1 tender dactylitis count
Standard Deviation 1.3
|
|
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 4
|
-1 tender dactylitis count
Standard Deviation 0.9
|
1 tender dactylitis count
Standard Deviation 1.0
|
-6 tender dactylitis count
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
0 tender dactylitis count
Standard Deviation 1.5
|
|
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 8
|
-3 tender dactylitis count
Standard Deviation 3.3
|
0 tender dactylitis count
Standard Deviation 1.5
|
-6 tender dactylitis count
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
0 tender dactylitis count
Standard Deviation 2.1
|
|
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 12
|
-3 tender dactylitis count
Standard Deviation 3.0
|
-1 tender dactylitis count
Standard Deviation 1.5
|
-6 tender dactylitis count
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
0 tender dactylitis count
Standard Deviation 2.2
|
|
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Change From Baseline at Week 16
|
-3 tender dactylitis count
Standard Deviation 3.3
|
0 tender dactylitis count
Standard Deviation 2.1
|
-6 tender dactylitis count
Standard Deviation NA
SD cannot be calculated for 1 participant.
|
0 tender dactylitis count
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability).
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Baseline
|
1.05 score on a scale
Standard Deviation 0.601
|
0.80 score on a scale
Standard Deviation 0.547
|
0.95 score on a scale
Standard Deviation 0.630
|
0.92 score on a scale
Standard Deviation 0.602
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 2
|
-0.13 score on a scale
Standard Deviation 0.293
|
-0.09 score on a scale
Standard Deviation 0.345
|
0.03 score on a scale
Standard Deviation 0.332
|
-0.08 score on a scale
Standard Deviation 0.321
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 8
|
-0.37 score on a scale
Standard Deviation 0.387
|
-0.24 score on a scale
Standard Deviation 0.516
|
-0.16 score on a scale
Standard Deviation 0.281
|
-0.12 score on a scale
Standard Deviation 0.407
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 12
|
-0.33 score on a scale
Standard Deviation 0.374
|
-0.20 score on a scale
Standard Deviation 0.477
|
-0.39 score on a scale
Standard Deviation 0.274
|
-0.07 score on a scale
Standard Deviation 0.438
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 16
|
-0.33 score on a scale
Standard Deviation 0.407
|
-0.33 score on a scale
Standard Deviation 0.575
|
-0.34 score on a scale
Standard Deviation 0.297
|
-0.19 score on a scale
Standard Deviation 0.487
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Change From Baseline at Week 4
|
-0.20 score on a scale
Standard Deviation 0.264
|
-0.24 score on a scale
Standard Deviation 0.474
|
-0.16 score on a scale
Standard Deviation 0.297
|
-0.01 score on a scale
Standard Deviation 0.337
|
SECONDARY outcome
Timeframe: Baseline, 4, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue).
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
Baseline
|
32.5 score on a scale
Standard Deviation 9.83
|
33.9 score on a scale
Standard Deviation 13.06
|
33.4 score on a scale
Standard Deviation 10.66
|
31.4 score on a scale
Standard Deviation 10.37
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
Change From Baseline at Week 4
|
4.6 score on a scale
Standard Deviation 9.75
|
4.1 score on a scale
Standard Deviation 8.53
|
0.5 score on a scale
Standard Deviation 7.23
|
1.6 score on a scale
Standard Deviation 6.53
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
Change From Baseline at Week 16
|
5.6 score on a scale
Standard Deviation 9.45
|
6.4 score on a scale
Standard Deviation 10.42
|
4.6 score on a scale
Standard Deviation 9.18
|
2.4 score on a scale
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline, 4, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status).
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
Change From Baseline at Week 4
|
3.3 score on a scale
Standard Deviation 9.66
|
0.4 score on a scale
Standard Deviation 9.40
|
0.6 score on a scale
Standard Deviation 6.80
|
-0.4 score on a scale
Standard Deviation 5.58
|
|
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
Baseline
|
49.9 score on a scale
Standard Deviation 12.48
|
50.5 score on a scale
Standard Deviation 11.43
|
44.8 score on a scale
Standard Deviation 7.67
|
48.9 score on a scale
Standard Deviation 9.27
|
|
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
Change From Baseline at Week 16
|
2.8 score on a scale
Standard Deviation 10.34
|
0.2 score on a scale
Standard Deviation 9.42
|
2.9 score on a scale
Standard Deviation 9.31
|
0.3 score on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Baseline, 4, and 16 weeksPopulation: Participants in the FAS with available data were analyzed.
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status).
Outcome measures
| Measure |
Filgotinib 200 mg (Main Study)
n=19 Participants
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 Participants
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab (Main Study)
n=8 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 Participants
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
Baseline
|
37.1 score on a scale
Standard Deviation 8.11
|
39.2 score on a scale
Standard Deviation 9.60
|
39.2 score on a scale
Standard Deviation 7.58
|
37.2 score on a scale
Standard Deviation 7.83
|
|
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
Change From Baseline at Week 4
|
6.4 score on a scale
Standard Deviation 5.87
|
5.6 score on a scale
Standard Deviation 7.00
|
2.9 score on a scale
Standard Deviation 7.12
|
1.1 score on a scale
Standard Deviation 5.24
|
|
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
Change From Baseline at Week 16
|
8.4 score on a scale
Standard Deviation 6.86
|
7.4 score on a scale
Standard Deviation 9.80
|
8.1 score on a scale
Standard Deviation 7.73
|
4.6 score on a scale
Standard Deviation 7.85
|
Adverse Events
Filgotinib 200 mg (Main Study)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Filgotinib 100 mg (Main Study)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Adalimumab 40 mg (Main Study)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Main Study)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Filgotinib 200 mg From Placebo (LTE)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Filgotinib 100 mg From Placebo (LTE)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Filgotinib 200 mg (Main Study)
n=19 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab 40 mg (Main Study)
n=9 participants at risk
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 participants at risk
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
n=4 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
|
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
n=3 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
|
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
n=1 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
n=1 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 200 mg From Placebo (LTE)
n=2 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
Filgotinib 100 mg From Placebo (LTE)
n=2 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
50.0%
1/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
Other adverse events
| Measure |
Filgotinib 200 mg (Main Study)
n=19 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 100 mg (Main Study)
n=19 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily + PTM Adalimumab SC injection every two weeks for 16 weeks.
|
Adalimumab 40 mg (Main Study)
n=9 participants at risk
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + Adalimumab 40 mg SC injection every two weeks for 16 weeks.
|
Placebo (Main Study)
n=20 participants at risk
PTM filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily + PTM adalimumab SC injection every two weeks for 16 weeks.
|
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
n=4 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 200 mg in the Main Study.
|
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
n=3 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received filgotinib 100 mg in the Main Study.
|
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
n=1 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
n=1 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received adalimumab 40 mg in the Main Study.
|
Filgotinib 200 mg From Placebo (LTE)
n=2 participants at risk
Filgotinib 200 mg tablet orally once daily + PTM filgotinib 100 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
Filgotinib 100 mg From Placebo (LTE)
n=2 participants at risk
Filgotinib 100 mg tablet orally once daily + PTM filgotinib 200 mg tablet orally once daily for up to 34 weeks. Participants received placebo in the Main Study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
50.0%
1/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
25.0%
1/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
15.0%
3/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
11.1%
1/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
General disorders
Asthenia
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
50.0%
1/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Covid-19
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
10.0%
2/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
11.1%
1/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
11.1%
1/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
10.0%
2/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
50.0%
1/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
50.0%
1/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.0%
1/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
5.3%
1/19 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/9 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/20 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/4 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/3 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/1 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
0.00%
0/2 • Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER