Trial Outcomes & Findings for Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX) (NCT NCT00928512)
NCT ID: NCT00928512
Last Updated: 2015-10-30
Results Overview
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).
COMPLETED
PHASE2
237 participants
16cweeks
2015-10-30
Participant Flow
A total of 16 patients discontinued prior to Week 16.At Week 20, all patients on secukinumab 25-150 mg who were responders continued on their randomized dose regimens. Non-responders in the 25 mg and 75 mg groups were up-titrated to 150 mg and non-responders in the 150 mg group were up-titrated to 300 mg.
Participant milestones
| Measure |
Secukinumab 300mg
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
49
|
54
|
50
|
|
Overall Study
Discontinued Prior to Week 16
|
3
|
0
|
2
|
6
|
5
|
|
Overall Study
Reassigned at Week 20 (Non-responders)
|
0
|
23
|
23
|
27
|
45
|
|
Overall Study
Not Reassigned at Week 20 (Responders)
|
37
|
20
|
23
|
18
|
0
|
|
Overall Study
New Groups After Reassignment
|
60
|
115
|
23
|
18
|
0
|
|
Overall Study
Completed Week 16
|
38
|
43
|
47
|
48
|
45
|
|
Overall Study
Entered/Continued to Week 20 (All)
|
37
|
43
|
46
|
45
|
45
|
|
Overall Study
COMPLETED
|
31
|
37
|
38
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
11
|
21
|
15
|
Reasons for withdrawal
| Measure |
Secukinumab 300mg
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
2
|
8
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
4
|
7
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
3
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
3
|
|
Overall Study
Administrative Problems
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Baseline characteristics by cohort
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=54 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 11.44 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 10.46 • n=21 Participants
|
54.9 years
STANDARD_DEVIATION 10.75 • n=10 Participants
|
|
Age, Customized
<18 years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Customized
>=18 - < 41 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Age, Customized
>=41 - < 65 years
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
169 Participants
n=10 Participants
|
|
Age, Customized
>=65 - < 75 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Age, Customized
>=75 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
183 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
176 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Geographical Region
East Asia
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Geographical Region
Non-East Asia
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
188 Participants
n=10 Participants
|
|
Functional Status
Class l
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Functional Status
Class ll
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
157 Participants
n=10 Participants
|
|
Functional Status
Class lll
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Functional Status
Class IV
|
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
|
0 Participants
n=10 Participants
|
|
Weight
|
78.9 kg
STANDARD_DEVIATION 23.91 • n=5 Participants
|
72.1 kg
STANDARD_DEVIATION 16.52 • n=7 Participants
|
74.3 kg
STANDARD_DEVIATION 15.70 • n=5 Participants
|
71.3 kg
STANDARD_DEVIATION 14.16 • n=4 Participants
|
75.9 kg
STANDARD_DEVIATION 15.61 • n=21 Participants
|
74.3 kg
STANDARD_DEVIATION 17.27 • n=10 Participants
|
|
Weight Group
<90 kg
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
197 Participants
n=10 Participants
|
|
Weight Group
>=90 kg
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
|
Height
|
163.3 cm
STANDARD_DEVIATION 10.03 • n=5 Participants
|
161.9 cm
STANDARD_DEVIATION 10.84 • n=7 Participants
|
165.4 cm
STANDARD_DEVIATION 9.52 • n=5 Participants
|
163.2 cm
STANDARD_DEVIATION 7.07 • n=4 Participants
|
166.1 cm
STANDARD_DEVIATION 7.62 • n=21 Participants
|
164.0 cm
STANDARD_DEVIATION 9.06 • n=10 Participants
|
|
BMI (body mass index)
|
29.48 kg/m^2
STANDARD_DEVIATION 8.383 • n=5 Participants
|
27.32 kg/m^2
STANDARD_DEVIATION 4.673 • n=7 Participants
|
27.03 kg/m^2
STANDARD_DEVIATION 4.936 • n=5 Participants
|
26.69 kg/m^2
STANDARD_DEVIATION 4.768 • n=4 Participants
|
24.47 kg/m^2
STANDARD_DEVIATION 5.229 • n=21 Participants
|
27.52 kg/m^2
STANDARD_DEVIATION 5.693 • n=10 Participants
|
PRIMARY outcome
Timeframe: 16cweeksPopulation: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks
|
22 Participants
|
20 Participants
|
23 Participants
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire \[HAQ©\] score) and Acute phase reactant (C-reactive protein \[hsCRP\]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16
ACR50 response
|
7 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16
ACR70 response
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Weeks2, 4, 8, 12, 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 2: ACR20 response
|
7 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 2: ACR50 response
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 2: ACR70 response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 4: ACR20 response
|
7 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 4: ACR50 response
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 4: ACR70 response
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 8: ACR20 response
|
16 Participants
|
17 Participants
|
22 Participants
|
15 Participants
|
11 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 8: ACR50 response
|
3 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 8: ACR70 response
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 12: ACR20 response
|
20 Participants
|
24 Participants
|
25 Participants
|
17 Participants
|
12 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 12: ACR50 response
|
6 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 12: ACR70 response
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 16: ACR20 response
|
22 Participants
|
20 Participants
|
23 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 16: ACR50 response
|
7 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16
Week 16: ACR70 response
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient's global assessment of disease activity.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)
|
-1.29 scores on a scale
Standard Error 0.186
|
-1.35 scores on a scale
Standard Error 0.181
|
-1.46 scores on a scale
Standard Error 0.170
|
-1.13 scores on a scale
Standard Error 0.165
|
-0.96 scores on a scale
Standard Error 0.171
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=48 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=52 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=47 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)
SF-36 physical component score
|
3.42 scores on a scale-change from baseline
Standard Deviation 5.574 • Interval -2.66 to 3.6
|
4.51 scores on a scale-change from baseline
Standard Deviation 6.800 • Interval -2.07 to 3.58
|
3.48 scores on a scale-change from baseline
Standard Deviation 5.961 • Interval -2.05 to 3.32
|
2.15 scores on a scale-change from baseline
Standard Deviation 7.176 • Interval -3.4 to 2.33
|
2.47 scores on a scale-change from baseline
Standard Deviation 7.481 • Interval 0.0 to 0.0
|
|
Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)
SF-36 mental component score
|
-0.76 scores on a scale-change from baseline
Standard Deviation 11.421 • Interval -5.95 to 3.82
|
3.59 scores on a scale-change from baseline
Standard Deviation 9.631 • Interval -3.08 to 4.41
|
2.58 scores on a scale-change from baseline
Standard Deviation 11.479 • Interval -4.72 to 3.05
|
1.06 scores on a scale-change from baseline
Standard Deviation 9.299 • Interval -2.07 to 5.03
|
1.10 scores on a scale-change from baseline
Standard Deviation 10.231 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=48 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16
|
2.80 scores on a scale-change from baseline
Standard Deviation 7.181 • Interval -1.25 to 6.0
|
5.18 scores on a scale-change from baseline
Standard Deviation 8.470 • Interval -2.0 to 5.0
|
3.89 scores on a scale-change from baseline
Standard Deviation 8.368 • Interval -2.0 to 5.0
|
1.95 scores on a scale-change from baseline
Standard Deviation 8.232 • Interval 3.0 to 4.0
|
1.64 scores on a scale-change from baseline
Standard Deviation 8.464 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP \<3.2 with DAS28-CRP improvement \>1.2 corresponds to 'good response'; Week 16 DAS28-CRP \<3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement \>1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP \>5.1 with DAS28-CRP improvement \>1.2 correspond to 'moderate response; Week 16 DAS28-CRP \<3.2 with DAS28-CRP improvement \<0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement \<0.6, or Week 16 DAS28-CRP \>5.1 with DAS28-CRP improvement between 0.6 to 1.2 or \<0.6 correspond to 'no response'.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16
Good Response
|
19.5 Percentage of participants
|
18.6 Percentage of participants
|
22.4 Percentage of participants
|
18.9 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16
Moderate Response
|
43.9 Percentage of participants
|
41.9 Percentage of participants
|
46.9 Percentage of participants
|
30.2 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16
No Response
|
36.6 Percentage of participants
|
39.5 Percentage of participants
|
30.6 Percentage of participants
|
50.9 Percentage of participants
|
44.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
Only values that were above normal range (12 U/mL) were were included.
Outcome measures
| Measure |
Secukinumab 300mg
n=29 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=27 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=34 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=36 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=32 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16
|
-5.66 U/mL
Standard Deviation 210.235
|
-32.11 U/mL
Standard Deviation 196.574
|
-77.62 U/mL
Standard Deviation 341.985
|
66.44 U/mL
Standard Deviation 379.723
|
85.63 U/mL
Standard Deviation 499.964
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
Only values that were above normal range (20 units) were included.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16
Concentrations at baseline (n: 33, 32, 43, 46, 38)
|
1444.67 Units
Standard Deviation 1450.438
|
1098.81 Units
Standard Deviation 1238.627
|
1178.88 Units
Standard Deviation 1390.458
|
1342.50 Units
Standard Deviation 1544.205
|
1406.79 Units
Standard Deviation 1496.032
|
|
Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16
Concentrations at Week 16 (n: 30, 30, 41, 42, 36)
|
1478.53 Units
Standard Deviation 1767.070
|
1330.63 Units
Standard Deviation 1355.193
|
1155.27 Units
Standard Deviation 1550.003
|
1443.07 Units
Standard Deviation 1640.771
|
1556.06 Units
Standard Deviation 1596.122
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28\*(s/S)).
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16
|
-5.4 swollen joints
Standard Error 0.75
|
-5.2 swollen joints
Standard Error 0.73
|
-6.0 swollen joints
Standard Error 0.68
|
-4.4 swollen joints
Standard Error 0.66
|
-4.6 swollen joints
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16
|
-1.48 scores on a scale
Standard Error 0.196
|
-1.55 scores on a scale
Standard Error 0.191
|
-1.65 scores on a scale
Standard Error 0.179
|
-1.28 scores on a scale
Standard Error 0.174
|
-1.14 scores on a scale
Standard Error 0.181
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28\*(t/T)).
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16
|
-6.3 tender joints
Standard Error 0.94
|
-6.5 tender joints
Standard Error 0.91
|
-6.3 tender joints
Standard Error 0.86
|
-5.6 tender joints
Standard Error 0.83
|
-5.0 tender joints
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from "no pain" to "unbearable pain" after the question "Please indicate with a vertical mark ( \| ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16
|
-9.0 VAS in mm
Standard Error 3.25
|
-9.1 VAS in mm
Standard Error 3.16
|
-11.6 VAS in mm
Standard Error 2.97
|
-9.5 VAS in mm
Standard Error 2.88
|
-9.1 VAS in mm
Standard Error 2.99
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The patient's global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing".
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16
|
-10.1 VAS in mm
Standard Error 3.27
|
-10.5 VAS in mm
Standard Error 3.19
|
-18.4 VAS in mm
Standard Error 2.99
|
-10.6 VAS in mm
Standard Error 2.90
|
-9.9 VAS in mm
Standard Error 3.01
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
The physician's global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing".
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16
|
-22.8 VAS in mm
Standard Error 2.99
|
-26.7 VAS in mm
Standard Error 2.91
|
-25.4 VAS in mm
Standard Error 2.73
|
-18.1 VAS in mm
Standard Error 2.65
|
-15.2 VAS in mm
Standard Error 2.74
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing \& grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16
|
-0.297 scores on a scale
Standard Error 0.0698
|
-0.256 scores on a scale
Standard Error 0.0688
|
-0.233 scores on a scale
Standard Error 0.0639
|
-0.202 scores on a scale
Standard Error 0.0627
|
-0.116 scores on a scale
Standard Error 0.0652
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)
|
-6.54 mg/L
Standard Error 2.237
|
-7.76 mg/L
Standard Error 2.175
|
-9.09 mg/L
Standard Error 2.042
|
-4.08 mg/L
Standard Error 1.984
|
0.30 mg/L
Standard Error 2.035
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit \>=3) assessments on all of the specified efficacy variables.
Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.
Outcome measures
| Measure |
Secukinumab 300mg
n=41 Participants
Secukinumab 300mg s.c. q4wk
|
Secukinumab 150mg
n=43 Participants
Secukinumab 150mg s.c. q4wk
|
Secukinumab 75mg
n=49 Participants
Secukinumab 75mg s.c. q4wk
|
Secukinumab 25mg
n=53 Participants
Secukinumab 25mg s.c. q4wk
|
Secukinumab Placebo
n=50 Participants
Secukinumab Placebo s.c. q4wk
|
|---|---|---|---|---|---|
|
Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16
|
-13.51 mm/hr
Standard Error 2.630
|
-15.06 mm/hr
Standard Error 2.564
|
-15.43 mm/hr
Standard Error 2.426
|
-9.86 mm/hr
Standard Error 2.331
|
-6.12 mm/hr
Standard Error 2.395
|
Adverse Events
AIN457 25mg
AIN457 75mg
AIN457 150mg
AIN457 300mg
Placebo
AIN457 25mg (Wk 20 to End of Study)
AIN457 75mg (Wk 20 to End of Study)
AIN457 150mg (Wk 20 to End of Study)
AIN457 300mg (Wk 20 to End of Study)
Serious adverse events
| Measure |
AIN457 25mg
n=54 participants at risk
Up to Week 20 - AIN457 25mg
|
AIN457 75mg
n=49 participants at risk
Up to Week 20 - AIN457 75mg
|
AIN457 150mg
n=43 participants at risk
Up to Week 20 - AIN457 150mg
|
AIN457 300mg
n=41 participants at risk
Up to Week 20 - AIN457 300mg
|
Placebo
n=50 participants at risk
Up to Week 20 - Placebo
|
AIN457 25mg (Wk 20 to End of Study)
n=18 participants at risk
From week 20 through end of study - AIN457 25mg
|
AIN457 75mg (Wk 20 to End of Study)
n=23 participants at risk
From week 20 through end of study - AIN457 75mg
|
AIN457 150mg (Wk 20 to End of Study)
n=115 participants at risk
From week 20 through end of study - AIN457 150mg
|
AIN457 300mg (Wk 20 to End of Study)
n=60 participants at risk
From week 20 through end of study - AIN457 300mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Bronchitis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Lung abscess
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Infections and infestations
Viral infection
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
2.0%
1/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Vascular disorders
Hypertension
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Vascular disorders
Rheumatoid vasculitis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
Other adverse events
| Measure |
AIN457 25mg
n=54 participants at risk
Up to Week 20 - AIN457 25mg
|
AIN457 75mg
n=49 participants at risk
Up to Week 20 - AIN457 75mg
|
AIN457 150mg
n=43 participants at risk
Up to Week 20 - AIN457 150mg
|
AIN457 300mg
n=41 participants at risk
Up to Week 20 - AIN457 300mg
|
Placebo
n=50 participants at risk
Up to Week 20 - Placebo
|
AIN457 25mg (Wk 20 to End of Study)
n=18 participants at risk
From week 20 through end of study - AIN457 25mg
|
AIN457 75mg (Wk 20 to End of Study)
n=23 participants at risk
From week 20 through end of study - AIN457 75mg
|
AIN457 150mg (Wk 20 to End of Study)
n=115 participants at risk
From week 20 through end of study - AIN457 150mg
|
AIN457 300mg (Wk 20 to End of Study)
n=60 participants at risk
From week 20 through end of study - AIN457 300mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54
|
2.0%
1/49
|
2.3%
1/43
|
0.00%
0/41
|
4.0%
2/50
|
5.6%
1/18
|
4.3%
1/23
|
3.5%
4/115
|
3.3%
2/60
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/54
|
8.2%
4/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
2.6%
3/115
|
0.00%
0/60
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/54
|
4.1%
2/49
|
2.3%
1/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
3.3%
2/60
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
2.0%
1/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
3.3%
2/60
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
8.7%
2/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
|
4.1%
2/49
|
2.3%
1/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
General disorders
Fatigue
|
1.9%
1/54
|
0.00%
0/49
|
2.3%
1/43
|
2.4%
1/41
|
2.0%
1/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
General disorders
Injection site erythema
|
1.9%
1/54
|
2.0%
1/49
|
4.7%
2/43
|
2.4%
1/41
|
2.0%
1/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
1.7%
1/60
|
|
General disorders
Injection site pain
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
4.9%
2/41
|
2.0%
1/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
General disorders
Injection site swelling
|
1.9%
1/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
General disorders
Oedema peripheral
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.9%
1/54
|
2.0%
1/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
1.7%
2/115
|
1.7%
1/60
|
|
Infections and infestations
Bronchitis
|
1.9%
1/54
|
2.0%
1/49
|
0.00%
0/43
|
2.4%
1/41
|
2.0%
1/50
|
0.00%
0/18
|
0.00%
0/23
|
4.3%
5/115
|
3.3%
2/60
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
4/54
|
2.0%
1/49
|
9.3%
4/43
|
9.8%
4/41
|
6.0%
3/50
|
5.6%
1/18
|
17.4%
4/23
|
13.0%
15/115
|
13.3%
8/60
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54
|
2.0%
1/49
|
0.00%
0/43
|
7.3%
3/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
8.3%
5/60
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54
|
0.00%
0/49
|
2.3%
1/43
|
0.00%
0/41
|
4.0%
2/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/54
|
2.0%
1/49
|
4.7%
2/43
|
0.00%
0/41
|
4.0%
2/50
|
11.1%
2/18
|
0.00%
0/23
|
5.2%
6/115
|
1.7%
1/60
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/54
|
4.1%
2/49
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/50
|
11.1%
2/18
|
4.3%
1/23
|
4.3%
5/115
|
1.7%
1/60
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
3.3%
2/60
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.87%
1/115
|
1.7%
1/60
|
|
Investigations
Monocyte count decreased
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
1.7%
1/60
|
|
Investigations
Weight decreased
|
0.00%
0/54
|
0.00%
0/49
|
2.3%
1/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/54
|
0.00%
0/49
|
4.7%
2/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/54
|
2.0%
1/49
|
2.3%
1/43
|
0.00%
0/41
|
4.0%
2/50
|
0.00%
0/18
|
0.00%
0/23
|
1.7%
2/115
|
0.00%
0/60
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/54
|
0.00%
0/49
|
2.3%
1/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
1.7%
1/60
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
2/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
2.0%
1/50
|
5.6%
1/18
|
4.3%
1/23
|
4.3%
5/115
|
1.7%
1/60
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54
|
4.1%
2/49
|
2.3%
1/43
|
4.9%
2/41
|
4.0%
2/50
|
0.00%
0/18
|
0.00%
0/23
|
1.7%
2/115
|
5.0%
3/60
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.4%
4/54
|
0.00%
0/49
|
4.7%
2/43
|
0.00%
0/41
|
4.0%
2/50
|
11.1%
2/18
|
0.00%
0/23
|
5.2%
6/115
|
5.0%
3/60
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54
|
0.00%
0/49
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Nervous system disorders
Headache
|
0.00%
0/54
|
2.0%
1/49
|
2.3%
1/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
2.6%
3/115
|
5.0%
3/60
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
4.0%
2/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Psychiatric disorders
Depression
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
3.3%
2/60
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/54
|
2.0%
1/49
|
2.3%
1/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.9%
1/54
|
0.00%
0/49
|
0.00%
0/43
|
2.4%
1/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
1.7%
1/60
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
5.6%
1/18
|
0.00%
0/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54
|
0.00%
0/49
|
4.7%
2/43
|
0.00%
0/41
|
6.0%
3/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
4.0%
2/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
1/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.00%
0/115
|
3.3%
2/60
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
1.9%
1/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.87%
1/115
|
0.00%
0/60
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/54
|
4.1%
2/49
|
0.00%
0/43
|
4.9%
2/41
|
0.00%
0/50
|
0.00%
0/18
|
0.00%
0/23
|
0.87%
1/115
|
1.7%
1/60
|
|
Vascular disorders
Hypertension
|
0.00%
0/54
|
2.0%
1/49
|
0.00%
0/43
|
0.00%
0/41
|
4.0%
2/50
|
5.6%
1/18
|
4.3%
1/23
|
2.6%
3/115
|
1.7%
1/60
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/54
|
0.00%
0/49
|
0.00%
0/43
|
0.00%
0/41
|
0.00%
0/50
|
0.00%
0/18
|
4.3%
1/23
|
0.00%
0/115
|
0.00%
0/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER