Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate (NCT NCT02885181)
NCT ID: NCT02885181
Last Updated: 2018-09-19
Results Overview
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2018-09-19
Participant Flow
Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 21 September 2016. The last study visit occurred on 20 September 2017.
140 participants were screened.
Participant milestones
| Measure |
GS-9876 30 mg
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
Filgotinib 2 x 100 mg tablets orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
21
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
GS-9876 30 mg
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
Filgotinib 2 x 100 mg tablets orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Overall Study
Investigator's Discretion
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Baseline characteristics by cohort
| Measure |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=20 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=22 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
53 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
54 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
55 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
79 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
77 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
|
00 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Moldova
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
Georgia
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Disease Activity Score 28 C-Reactive Protein (DAS28 CRP)
|
5.78 units on a scale
STANDARD_DEVIATION 0.691 • n=5 Participants
|
5.65 units on a scale
STANDARD_DEVIATION 0.941 • n=7 Participants
|
6.09 units on a scale
STANDARD_DEVIATION 1.112 • n=5 Participants
|
5.51 units on a scale
STANDARD_DEVIATION 1.003 • n=4 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 0.961 • n=21 Participants
|
|
Health Assessment Questionnaire Disease Index (HAQ-DI)
|
1.38 units on a scale
STANDARD_DEVIATION 0.650 • n=5 Participants
|
1.47 units on a scale
STANDARD_DEVIATION 0.425 • n=7 Participants
|
1.61 units on a scale
STANDARD_DEVIATION 0.591 • n=5 Participants
|
1.51 units on a scale
STANDARD_DEVIATION 0.577 • n=4 Participants
|
1.49 units on a scale
STANDARD_DEVIATION 0.563 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set (participants who received at least 1 dose of study drug) with available data were analyzed.
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) 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 |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=17 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=19 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
|
-1.26 units on a scale
Standard Deviation 1.276
|
-0.78 units on a scale
Standard Deviation 1.119
|
-2.46 units on a scale
Standard Deviation 1.242
|
-1.36 units on a scale
Standard Deviation 1.044
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set
American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP).
Outcome measures
| Measure |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=20 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=22 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
|
35.0 percentage of participants
|
25.0 percentage of participants
|
81.0 percentage of participants
|
40.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set
ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.
Outcome measures
| Measure |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=20 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=22 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ACR50 Improvement at Week 12
|
20.0 percentage of participants
|
20.0 percentage of participants
|
47.6 percentage of participants
|
22.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set
ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.
Outcome measures
| Measure |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=20 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=22 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ACR70 Improvement at Week 12
|
5.0 percentage of participants
|
15.0 percentage of participants
|
38.1 percentage of participants
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.
Outcome measures
| Measure |
GS-9876 30 mg
n=20 Participants
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=19 Participants
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 Participants
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=19 Participants
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
|
-0.46 units on a scale
Standard Deviation 0.480
|
-0.18 units on a scale
Standard Deviation 0.800
|
-0.70 units on a scale
Standard Deviation 0.649
|
-0.39 units on a scale
Standard Deviation 0.389
|
Adverse Events
GS-9876 30 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GS-9876 10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Filgotinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GS-9876 30 mg
n=20 participants at risk
GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
GS-9876 10 mg
n=20 participants at risk
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Filgotinib
n=21 participants at risk
Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
Placebo
n=22 participants at risk
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Cardiac disorders
Angina unstable
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Eye disorders
Hypermetropia
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
4.8%
1/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Epigastric discomfort
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
4.5%
1/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
9.5%
2/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
General disorders
Condition aggravated
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
4.8%
1/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Investigations
Liver function test increased
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Nervous system disorders
Amnesia
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/21 • Up to 12 weeks + 30 days
Safety Analysis Set
|
0.00%
0/22 • Up to 12 weeks + 30 days
Safety Analysis Set
|
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