Trial Outcomes & Findings for A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis (NCT NCT00380744)
NCT ID: NCT00380744
Last Updated: 2019-02-06
Results Overview
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Baseline up to Day 98
Results posted on
2019-02-06
Participant Flow
Participant Flow reports participants who discontinued from the study.
Participant milestones
| Measure |
Part B - 0.02 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.04 milligrams/kilogram/week (mg/kg/wk) of LY2189102, followed by 0.02 mg/kg/wk for 4 weeks (wks), intravenously (IV).
|
Part A - 0.1 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
Part B - 0.15 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
Part A - 0.3 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
All Parts - 1.0 mg/kg/wk LY2189102
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
All Parts - 2.5 mg/kg/wk LY2189102
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
All Parts - Placebo
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
20
|
4
|
23
|
25
|
25
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
20
|
4
|
20
|
4
|
23
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
4
|
20
|
4
|
23
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part B - 0.02 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.04 milligrams/kilogram/week (mg/kg/wk) of LY2189102, followed by 0.02 mg/kg/wk for 4 weeks (wks), intravenously (IV).
|
Part A - 0.1 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
Part B - 0.15 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
Part A - 0.3 mg/kg/wk LY2189102
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
All Parts - 1.0 mg/kg/wk LY2189102
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
All Parts - 2.5 mg/kg/wk LY2189102
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
All Parts - Placebo
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Part B - 0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
Part A - 0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
Part B - 0.15 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
Part A - 0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
All Parts - 1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
All Parts - 2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
All Parts - Placebo
n=25 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
52.0 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
54.0 years
STANDARD_DEVIATION 13.9 • n=10 Participants
|
55.7 years
STANDARD_DEVIATION 10.6 • n=115 Participants
|
53.2 years
STANDARD_DEVIATION 12.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
93 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
28 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
African
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
91 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
34 Participants
n=24 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
|
Region of Enrollment
Argentina
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 98Population: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=25 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Other Non-Serious AEs
|
8 Participants
|
4 Participants
|
10 Participants
|
4 Participants
|
7 Participants
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)Population: All participants who received at least 1 dose of study drug in part A \& B and had evaluable AUC0-168 hr,ss results. Per protocol analysis was performed per dose irrespective of study parts.
AUC0-168 hr,ss of individual participants was calculated by equation AUC=Dose/Clearance (CL), where the CL was estimated using a population PK model. Time frame for Part B: Day 1 predose, immediately after infusion (IAI), Day 14 and 28: predose and IAI, and Day 63 (Convenient time);
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102
|
196 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 52.5
|
902 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 26.8
|
1150 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 25.8
|
2810 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 29.0
|
6650 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 40.1
|
18200 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 37.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 21, 35, 63, and 98Population: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.
SDAI is calculated as the sum of 5 components: tender joint count (TJC) and swollen joint count (SJC), Patient Global Assessment (PtGA) of disease activity visual analog scale (VAS) and Physician's Global Assessment of Disease Activity (PGA) VAS, and C-reactive protein (CRP). Total Score scale range is 0 (remission) to 86 (high disease activity). A negative change from baseline indicated an improvement. Least Squares (LS) mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment \* time.
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=19 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=23 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Day 7
|
-6.81 units on a scale
Interval -12.72 to -0.89
|
-7.41 units on a scale
Interval -20.28 to 5.47
|
-5.72 units on a scale
Interval -11.58 to 0.15
|
-22.59 units on a scale
Interval -35.41 to -9.77
|
-4.60 units on a scale
Interval -9.97 to 0.77
|
-7.87 units on a scale
Interval -13.07 to -2.67
|
-8.46 units on a scale
Interval -13.86 to -3.05
|
|
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Day 63
|
-17.73 units on a scale
Interval -23.57 to -11.89
|
-20.48 units on a scale
Interval -33.36 to -7.61
|
-9.27 units on a scale
Interval -15.14 to -3.41
|
-21.72 units on a scale
Interval -34.54 to -8.9
|
-14.14 units on a scale
Interval -19.64 to -8.63
|
-19.49 units on a scale
Interval -24.63 to -14.35
|
-13.02 units on a scale
Interval -18.36 to -7.68
|
|
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Day 98
|
-12.43 units on a scale
Interval -18.27 to -6.59
|
-24.86 units on a scale
Interval -37.74 to -11.99
|
-13.23 units on a scale
Interval -19.09 to -7.37
|
-19.13 units on a scale
Interval -31.95 to -6.3
|
-15.16 units on a scale
Interval -20.53 to -9.79
|
-22.93 units on a scale
Interval -28.13 to -17.73
|
-16.70 units on a scale
Interval -22.18 to -11.22
|
|
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Day 21
|
-13.96 units on a scale
Interval -19.8 to -8.12
|
-19.61 units on a scale
Interval -32.48 to -6.74
|
-10.78 units on a scale
Interval -16.74 to -4.83
|
-26.16 units on a scale
Interval -38.98 to -13.34
|
-14.85 units on a scale
Interval -20.22 to -9.48
|
-13.57 units on a scale
Interval -18.71 to -8.42
|
-11.70 units on a scale
Interval -17.18 to -6.22
|
|
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Day 35
|
-17.45 units on a scale
Interval -23.29 to -11.61
|
-25.05 units on a scale
Interval -37.92 to -12.18
|
-10.69 units on a scale
Interval -16.55 to -4.82
|
-19.66 units on a scale
Interval -32.48 to -6.84
|
-13.76 units on a scale
Interval -19.13 to -8.39
|
-19.12 units on a scale
Interval -24.32 to -13.91
|
-16.63 units on a scale
Interval -21.96 to -11.29
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 21, 35, 63, and 98Population: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.
DAS28-4 (crp) is a modification of the original DAS based on TJC and SJC based on 28 joint counts, PGA VAS. DAS28-4 (crp) calculated as: 0.56\*square root (sqrt) (TJC)+0.28\*sqrt(SJC)+0.36\*ln(CRP+1)+0.014\*PGA+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment \* time.
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=19 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=23 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Day 7
|
-0.71 units on a scale
Interval -1.18 to -0.25
|
-0.68 units on a scale
Interval -1.69 to 0.33
|
-0.50 units on a scale
Interval -0.96 to -0.05
|
-1.66 units on a scale
Interval -2.66 to -0.65
|
-0.48 units on a scale
Interval -0.91 to -0.06
|
-0.59 units on a scale
Interval -0.99 to -0.18
|
-0.61 units on a scale
Interval -1.04 to -0.19
|
|
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Day 35
|
-1.43 units on a scale
Interval -1.89 to -0.98
|
-1.99 units on a scale
Interval -3.0 to -0.99
|
-0.84 units on a scale
Interval -1.29 to -0.38
|
-1.43 units on a scale
Interval -2.44 to -0.43
|
-1.06 units on a scale
Interval -1.48 to -0.64
|
-1.56 units on a scale
Interval -1.96 to -1.15
|
-1.04 units on a scale
Interval -1.46 to -0.62
|
|
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Day 98
|
-1.06 units on a scale
Interval -1.51 to -0.6
|
-2.25 units on a scale
Interval -3.25 to -1.24
|
-1.08 units on a scale
Interval -1.54 to -0.63
|
-1.84 units on a scale
Interval -2.84 to -0.83
|
-1.23 units on a scale
Interval -1.65 to -0.81
|
-1.89 units on a scale
Interval -2.29 to -1.48
|
-1.11 units on a scale
Interval -1.54 to -0.68
|
|
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Day 21
|
-1.22 units on a scale
Interval -1.68 to -0.77
|
-1.53 units on a scale
Interval -2.54 to -0.52
|
-0.88 units on a scale
Interval -1.35 to -0.42
|
-2.01 units on a scale
Interval -3.01 to -1.0
|
-1.13 units on a scale
Interval -1.55 to -0.71
|
-1.11 units on a scale
Interval -1.51 to -0.71
|
-0.71 units on a scale
Interval -1.14 to -0.28
|
|
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Day 63
|
-1.49 units on a scale
Interval -1.95 to -1.04
|
-1.71 units on a scale
Interval -2.71 to -0.7
|
-0.70 units on a scale
Interval -1.16 to -0.24
|
-2.17 units on a scale
Interval -3.17 to -1.16
|
-1.02 units on a scale
Interval -1.45 to -0.58
|
-1.58 units on a scale
Interval -1.98 to -1.18
|
-0.82 units on a scale
Interval -1.24 to -0.4
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, 21, 28, 35, 63, and 98Population: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.
CRP is a biomarker associated with inflammation and structural damage. A negative change from baseline indicates improvement. LS mean calculated using a repeated measures model and adjusted for baseline + treatment + time + treatment \* time.
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=19 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=24 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 14
|
-9.43 milligrams/deciliter (mg/dL)
Interval -15.89 to -2.97
|
-19.86 milligrams/deciliter (mg/dL)
Interval -34.35 to -5.38
|
-8.33 milligrams/deciliter (mg/dL)
Interval -14.96 to -1.7
|
-21.02 milligrams/deciliter (mg/dL)
Interval -35.47 to -6.57
|
-10.88 milligrams/deciliter (mg/dL)
Interval -16.9 to -4.85
|
-8.29 milligrams/deciliter (mg/dL)
Interval -14.07 to -2.51
|
-9.04 milligrams/deciliter (mg/dL)
Interval -15.0 to -3.07
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 98
|
-7.37 milligrams/deciliter (mg/dL)
Interval -13.83 to -0.91
|
-19.30 milligrams/deciliter (mg/dL)
Interval -33.79 to -4.81
|
-12.94 milligrams/deciliter (mg/dL)
Interval -19.57 to -6.31
|
-20.73 milligrams/deciliter (mg/dL)
Interval -35.18 to -6.28
|
-13.68 milligrams/deciliter (mg/dL)
Interval -19.7 to -7.65
|
-13.35 milligrams/deciliter (mg/dL)
Interval -19.17 to -7.53
|
-8.90 milligrams/deciliter (mg/dL)
Interval -14.91 to -2.89
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 7
|
-8.36 milligrams/deciliter (mg/dL)
Interval -14.88 to -1.84
|
-19.73 milligrams/deciliter (mg/dL)
Interval -34.21 to -5.24
|
-10.18 milligrams/deciliter (mg/dL)
Interval -16.81 to -3.55
|
-19.59 milligrams/deciliter (mg/dL)
Interval -34.04 to -5.14
|
-9.44 milligrams/deciliter (mg/dL)
Interval -15.47 to -3.42
|
-10.14 milligrams/deciliter (mg/dL)
Interval -15.96 to -4.32
|
-10.64 milligrams/deciliter (mg/dL)
Interval -16.6 to -4.68
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 21
|
-10.65 milligrams/deciliter (mg/dL)
Interval -17.11 to -4.19
|
-20.04 milligrams/deciliter (mg/dL)
Interval -34.53 to -5.55
|
-10.85 milligrams/deciliter (mg/dL)
Interval -17.54 to -4.16
|
-20.57 milligrams/deciliter (mg/dL)
Interval -35.02 to -6.12
|
-11.41 milligrams/deciliter (mg/dL)
Interval -17.43 to -5.38
|
-10.42 milligrams/deciliter (mg/dL)
Interval -16.2 to -4.64
|
-9.69 milligrams/deciliter (mg/dL)
Interval -15.69 to -3.68
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 28
|
-12.43 milligrams/deciliter (mg/dL)
Interval -18.9 to -5.97
|
-19.61 milligrams/deciliter (mg/dL)
Interval -34.1 to -5.13
|
-9.63 milligrams/deciliter (mg/dL)
Interval -16.26 to -3.0
|
-20.76 milligrams/deciliter (mg/dL)
Interval -35.21 to -6.31
|
-13.53 milligrams/deciliter (mg/dL)
Interval -19.6 to -7.46
|
-10.27 milligrams/deciliter (mg/dL)
Interval -16.05 to -4.49
|
-12.05 milligrams/deciliter (mg/dL)
Interval -18.02 to -6.09
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 35
|
-11.06 milligrams/deciliter (mg/dL)
Interval -17.52 to -4.59
|
-19.18 milligrams/deciliter (mg/dL)
Interval -33.67 to -4.7
|
-11.51 milligrams/deciliter (mg/dL)
Interval -18.14 to -4.88
|
-19.60 milligrams/deciliter (mg/dL)
Interval -34.05 to -5.15
|
-12.10 milligrams/deciliter (mg/dL)
Interval -18.13 to -6.08
|
-13.66 milligrams/deciliter (mg/dL)
Interval -19.48 to -7.83
|
-11.60 milligrams/deciliter (mg/dL)
Interval -17.53 to -5.68
|
|
Change From Baseline in C-Reactive Protein (CRP)
Day 63
|
-11.26 milligrams/deciliter (mg/dL)
Interval -17.72 to -4.79
|
-19.01 milligrams/deciliter (mg/dL)
Interval -33.5 to -4.52
|
-10.23 milligrams/deciliter (mg/dL)
Interval -16.86 to -3.6
|
-20.69 milligrams/deciliter (mg/dL)
Interval -35.14 to -6.24
|
-10.29 milligrams/deciliter (mg/dL)
Interval -16.41 to -4.17
|
-8.66 milligrams/deciliter (mg/dL)
Interval -14.44 to -2.88
|
-9.05 milligrams/deciliter (mg/dL)
Interval -14.98 to -3.13
|
SECONDARY outcome
Timeframe: Baseline, Days 35, 63, and 98Population: All data from all randomized participants who received at least 1 dose of study drug according to the assigned treatment. Per protocol analysis was performed per dose irrespective of study parts.
HAQ was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ score. If the participant had scores for fewer than 6 categories, the HAQ score was considered missing. The HAQ score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.
Outcome measures
| Measure |
0.02 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=20 Participants
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 Participants
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 Participants
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 Participants
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=24 Participants
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Day 35
|
-0.22 units on a scale
Interval -0.44 to 0.0
|
-0.09 units on a scale
Interval -0.58 to 0.4
|
-0.09 units on a scale
Interval -0.3 to 0.13
|
-0.22 units on a scale
Interval -0.71 to 0.26
|
-0.19 units on a scale
Interval -0.39 to 0.02
|
-0.71 units on a scale
Interval -0.9 to -0.51
|
-0.29 units on a scale
Interval -0.49 to -0.09
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Day 63
|
-0.22 units on a scale
Interval -0.44 to 0.0
|
-0.15 units on a scale
Interval -0.64 to 0.34
|
-0.04 units on a scale
Interval -0.25 to 0.18
|
-0.04 units on a scale
Interval -0.52 to 0.45
|
-0.19 units on a scale
Interval -0.39 to 0.01
|
-0.72 units on a scale
Interval -0.91 to -0.52
|
-0.28 units on a scale
Interval -0.48 to -0.08
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Day 98
|
-0.25 units on a scale
Interval -0.46 to -0.03
|
-0.34 units on a scale
Interval -0.83 to 0.15
|
-0.11 units on a scale
Interval -0.32 to 0.11
|
-0.13 units on a scale
Interval -0.62 to 0.36
|
-0.18 units on a scale
Interval -0.38 to 0.03
|
-0.75 units on a scale
Interval -0.95 to -0.56
|
-0.31 units on a scale
Interval -0.51 to -0.11
|
Adverse Events
0.02 mg/kg/wk LY2189102
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.1 mg/kg/wk LY2189102
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.15 mg/kg/wk LY2189102
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.3 mg/kg/wk LY2189102
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1.0 mg/kg/wk LY2189102
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
2.5 mg/kg/wk LY2189102
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.02 mg/kg/wk LY2189102
n=20 participants at risk
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 participants at risk
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=20 participants at risk
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 participants at risk
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 participants at risk
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 participants at risk
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=25 participants at risk
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
0.02 mg/kg/wk LY2189102
n=20 participants at risk
Participants were administered a loading dose of 0.04 mg/kg/wk of LY2189102, followed by 0.02 mg/kg/wk for 4 wks, IV.
|
0.1 mg/kg/wk LY2189102
n=4 participants at risk
Participants were administered a loading dose of 0.2 mg/kg/wk of LY2189102, followed by 0.1 mg/kg/wk for 4 wks, IV.
|
0.15 mg/kg/wk LY2189102
n=20 participants at risk
Participants were administered a loading dose of 0.3 mg/kg/wk of LY2189102, followed by 0.15 mg/kg/wk for 4 wks, IV.
|
0.3 mg/kg/wk LY2189102
n=4 participants at risk
Participants were administered a loading dose of 0.6 mg/kg/wk of LY2189102, followed by 0.3 mg/kg/wk for 4 wks, IV.
|
1.0 mg/kg/wk LY2189102
n=23 participants at risk
Participants were administered a loading dose of 2.0 mg/kg/wk of LY2189102, followed by 1.0 mg/kg/wk for 4 wks, IV.
|
2.5 mg/kg/wk LY2189102
n=25 participants at risk
Participants were administered a loading dose of 5.0 mg/kg/wk of LY2189102, followed by 2.5 mg/kg/wk for 4 wks, IV.
|
Placebo
n=25 participants at risk
Participants were administered matched placebo IV, once weekly for 4 wks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Cardiac disorders
Ventricular extrasystoles
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
|
Eye disorders
Ocular hyperaemia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Asthenia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Cyst
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 2
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 2
|
|
General disorders
Infusion site erythema
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 2
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 2
|
|
General disorders
Infusion site haematoma
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Infusion site reaction
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Injection site inflammation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Influenza
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Blood pressure increased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Blood urine present
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 2
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Investigations
Platelet count decreased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 2
|
0.00%
0/25
|
|
Investigations
White blood cell count decreased
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
1/20 • Number of events 2
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
12.0%
3/25 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/20
|
0.00%
0/4
|
10.0%
2/20 • Number of events 3
|
0.00%
0/4
|
13.0%
3/23 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Renal and urinary disorders
Chromaturia
|
5.0%
1/20 • Number of events 2
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/17
|
0.00%
0/2
|
5.9%
1/17 • Number of events 1
|
0.00%
0/4
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
4.3%
1/23 • Number of events 1
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
25.0%
1/4 • Number of events 1
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20
|
0.00%
0/4
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.0%
1/20 • Number of events 1
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
0.00%
0/25
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Vascular disorders
Hypertension
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/20
|
0.00%
0/4
|
0.00%
0/23
|
8.0%
2/25 • Number of events 5
|
0.00%
0/25
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60