Trial Outcomes & Findings for Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis (NCT NCT02862574)
NCT ID: NCT02862574
Last Updated: 2018-06-27
Results Overview
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2018-06-27
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 15 December 2016. The last study visit occurred on 07 August 2017.
28 participants were screened.
Participant milestones
| Measure |
Andecaliximab 300 mg
Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a tumor necrosis factor (TNF) inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
5
|
5
|
5
|
|
Double-Blind Treatment Period
COMPLETED
|
2
|
3
|
1
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
3
|
2
|
4
|
|
Open-Label Treatment Period
STARTED
|
2
|
3
|
1
|
|
Open-Label Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Open-Label Treatment Period
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Andecaliximab 300 mg
Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a tumor necrosis factor (TNF) inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
1
|
0
|
|
Double-Blind Treatment Period
Study Terminated by Sponsor
|
3
|
1
|
4
|
|
Open-Label Treatment Period
Study Terminated by Sponsor
|
2
|
3
|
1
|
Baseline Characteristics
Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Andecaliximab 300 mg
n=5 Participants
Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
n=5 Participants
Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
n=5 Participants
Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
58 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 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
|
|
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
|
|
Disease Activity Score C-reactive Protein (DAS28(CRP))
|
5.79 units on a scale
STANDARD_DEVIATION 0.814 • n=5 Participants
|
5.90 units on a scale
STANDARD_DEVIATION 0.752 • n=7 Participants
|
5.69 units on a scale
STANDARD_DEVIATION 0.887 • n=5 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 0.764 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 |
Andecaliximab 300 mg
n=2 Participants
Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
n=3 Participants
Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
n=3 Participants
Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|
|
Change From Baseline in DAS28(CRP) at Week 12
|
0.13 units on a scale
Standard Deviation 0.115
|
-1.51 units on a scale
Standard Deviation 0.670
|
-0.36 units on a scale
Standard Deviation 0.353
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 |
Andecaliximab 300 mg
n=5 Participants
Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
n=5 Participants
Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
n=5 Participants
Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|
|
Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 |
Andecaliximab 300 mg
n=5 Participants
Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg
n=5 Participants
Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo
n=5 Participants
Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|
|
Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 4 or 6 (± 1 day)The plasma concentrations of andecaliximab were not collected and were not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Andecaliximab 300 mg (Double-Blind)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Andecaliximab 150 mg (Double-Blind)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Double-Blind)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Andecaliximab 300 mg (Open-Label)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Andecaliximab 300 mg (Double-Blind)
n=5 participants at risk
Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg (Double-Blind)
n=5 participants at risk
Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo (Double-Blind)
n=5 participants at risk
Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 300 mg (Open-Label)
n=6 participants at risk
Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
Andecaliximab 300 mg (Double-Blind)
n=5 participants at risk
Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 150 mg (Double-Blind)
n=5 participants at risk
Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Placebo (Double-Blind)
n=5 participants at risk
Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
Andecaliximab 300 mg (Open-Label)
n=6 participants at risk
Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
16.7%
1/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
20.0%
1/5 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/6 • Baseline up to the last dose date (maximum: 127 days) plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug
|
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