Trial Outcomes & Findings for Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy (NCT NCT03344640)
NCT ID: NCT03344640
Last Updated: 2021-10-08
Results Overview
WORC PRO score at week 14. The WORC Index consists of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best. All Patients - Statistical analysis results of WORC scores at Week 14
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Week 14 (Day 99)
Results posted on
2021-10-08
Participant Flow
Of all patients randomized (N= 98; 100%) in the study, a total of 96 patients (98%) were dosed (49 patients in the secukinumab 300 mg group and 47 patients in the placebo group)
2 patients were not dosed, one patient decided to discontinue on Day 1 due to a common cold and one patient was a run-in failure
Participant milestones
| Measure |
Secukinumab
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
Placebo s.c.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
|
Follow-up Epoch
STARTED
|
46
|
44
|
|
Follow-up Epoch
COMPLETED
|
46
|
42
|
|
Follow-up Epoch
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Secukinumab
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
Placebo s.c.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Follow-up Epoch
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
Baseline characteristics by cohort
| Measure |
Secukinumab
n=49 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=47 Participants
Placebo s.c.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 14 (Day 99)Population: Pharmacodynamic (PD) Analysis Set
WORC PRO score at week 14. The WORC Index consists of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best. All Patients - Statistical analysis results of WORC scores at Week 14
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score at Week 14 in All Patients - Statistical Analysis Results of Total WORC Scores at Week 14
|
37.00 Scores on a scale
Interval 30.1 to 43.9
|
37.77 Scores on a scale
Interval 30.4 to 45.15
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 127, and End of StudyPopulation: PD Analysis Set
WORC score at Days 15, 29, 57, 85, 127, and End of Study (day 169). The scale range for WORC total score is 0-100, 0 being the worst possible outcome (highly symptomatic patient) and 100 being the best possible outcome (asymptomatic patient)
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
Day 29
|
22.35 Scores on a scale
Interval 16.38 to 28.32
|
19.49 Scores on a scale
Interval 13.11 to 25.86
|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
Day 15
|
12.39 Scores on a scale
Interval 6.99 to 17.79
|
8.42 Scores on a scale
Interval 2.66 to 14.18
|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
Day 57
|
28.74 Scores on a scale
Interval 22.19 to 35.29
|
30.11 Scores on a scale
Interval 23.08 to 37.13
|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
Day 85
|
34.86 Scores on a scale
Interval 28.18 to 41.53
|
33.48 Scores on a scale
Interval 26.35 to 40.61
|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
Day 127
|
41.86 Scores on a scale
Interval 34.96 to 48.77
|
38.50 Scores on a scale
Interval 31.12 to 45.88
|
|
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients
End of Study
|
43.41 Scores on a scale
Interval 36.21 to 50.61
|
40.97 Scores on a scale
Interval 33.27 to 48.66
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127, and End of StudyPopulation: PD Analysis Set
Patient Reported Outcome: Disability of Arm, Shoulder and Hand (QuickDASH) This questionnaire asks about symptoms as well participant's ability to do certain activities - ranging from 1 (No difficulty) to 5 (Unable). The scale range for QuickDASH total score is 0-100, 0 being the best possible outcome and 100 being the worst possible outcome
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 15
|
-11.64 Scores on a scale
Interval -16.14 to -7.14
|
-8.23 Scores on a scale
Interval -13.02 to -3.44
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 29
|
-18.31 Scores on a scale
Interval -23.2 to -13.41
|
-16.95 Scores on a scale
Interval -22.18 to -11.73
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 57
|
-22.43 Scores on a scale
Interval -27.55 to -17.3
|
-24.01 Scores on a scale
Interval -29.49 to -18.52
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 85
|
-28.14 Scores on a scale
Interval -33.55 to -22.73
|
-27.22 Scores on a scale
Interval -32.98 to -21.45
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 99
|
-29.45 Scores on a scale
Interval -34.72 to -24.19
|
-30.69 Scores on a scale
Interval -36.3 to -25.07
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Day 127
|
-32.86 Scores on a scale
Interval -38.26 to -27.46
|
-31.99 Scores on a scale
Interval -37.75 to -26.23
|
|
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
End of Study
|
-33.89 Scores on a scale
Interval -39.27 to -28.5
|
-35.40 Scores on a scale
Interval -41.13 to -29.67
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127, and End of StudyPopulation: PD Analysis Set
Patient Reported Outcome: American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score is self-administered and has 17 questions in the areas of shoulder symptoms and functions. The ASES total score ranges from 0 to 100 (best).
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 15
|
8.66 Scores on a scale
Interval 3.98 to 13.33
|
5.26 Scores on a scale
Interval 0.26 to 10.25
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 29
|
17.53 Scores on a scale
Interval 12.35 to 22.71
|
14.37 Scores on a scale
Interval 8.82 to 19.92
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 57
|
24.15 Scores on a scale
Interval 18.34 to 29.96
|
22.56 Scores on a scale
Interval 16.31 to 28.81
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 85
|
30.50 Scores on a scale
Interval 24.51 to 36.5
|
26.97 Scores on a scale
Interval 20.51 to 33.43
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 99
|
31.29 Scores on a scale
Interval 25.28 to 37.31
|
27.79 Scores on a scale
Interval 21.33 to 34.26
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
Day 127
|
34.92 Scores on a scale
Interval 28.8 to 41.05
|
32.94 Scores on a scale
Interval 26.33 to 39.56
|
|
American Shoulder and Elbow Surgeons (ASES) Score Over Time
End of Study
|
37.29 Scores on a scale
Interval 30.97 to 43.62
|
36.15 Scores on a scale
Interval 29.33 to 42.97
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127, and End of StudyPopulation: PD Analysis Set
Patient Reported Outcome: Statistical analysis results of EQ-5D-5L for Your health Today questionnaire, which reflects how good or bad the subjets Health is on a scale from 0 (worst health) to 100 (best health).
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Your Health Today Score Over Time
Day 15
|
-0.22 Scores on a scale
Interval -4.02 to 3.58
|
0.02 Scores on a scale
Interval -4.02 to 4.07
|
|
Your Health Today Score Over Time
Day 29
|
3.27 Scores on a scale
Interval -0.71 to 7.25
|
3.56 Scores on a scale
Interval -0.69 to 7.81
|
|
Your Health Today Score Over Time
Day 57
|
3.19 Scores on a scale
Interval -1.07 to 7.45
|
9.02 Scores on a scale
Interval 4.45 to 13.59
|
|
Your Health Today Score Over Time
Day 85
|
7.36 Scores on a scale
Interval 2.84 to 11.89
|
7.79 Scores on a scale
Interval 2.96 to 12.62
|
|
Your Health Today Score Over Time
Day 99
|
8.75 Scores on a scale
Interval 4.13 to 13.38
|
10.01 Scores on a scale
Interval 5.09 to 14.94
|
|
Your Health Today Score Over Time
Day 127
|
9.55 Scores on a scale
Interval 5.29 to 13.8
|
13.59 Scores on a scale
Interval 9.05 to 18.13
|
|
Your Health Today Score Over Time
End of Study
|
10.22 Scores on a scale
Interval 4.84 to 15.6
|
12.13 Scores on a scale
Interval 6.36 to 17.89
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127 and End of StudyPopulation: PD Analysis Set
Patient Reported Outcome: Statistical analysis results of EQ-5D-5L Index score, which contains 5 items to assess Health Status (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction.
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
EQ-5D-5L Index Score Over Time
Day 15
|
0.07 Scores on a scale
Interval 0.05 to 0.1
|
0.04 Scores on a scale
Interval 0.01 to 0.07
|
|
EQ-5D-5L Index Score Over Time
Day 29
|
0.10 Scores on a scale
Interval 0.07 to 0.13
|
0.09 Scores on a scale
Interval 0.05 to 0.12
|
|
EQ-5D-5L Index Score Over Time
Day 57
|
0.12 Scores on a scale
Interval 0.09 to 0.15
|
0.11 Scores on a scale
Interval 0.08 to 0.15
|
|
EQ-5D-5L Index Score Over Time
Day 85
|
0.16 Scores on a scale
Interval 0.13 to 0.19
|
0.14 Scores on a scale
Interval 0.1 to 0.18
|
|
EQ-5D-5L Index Score Over Time
Day 99
|
0.16 Scores on a scale
Interval 0.13 to 0.2
|
0.15 Scores on a scale
Interval 0.11 to 0.19
|
|
EQ-5D-5L Index Score Over Time
Day 127
|
0.19 Scores on a scale
Interval 0.15 to 0.23
|
0.17 Scores on a scale
Interval 0.13 to 0.21
|
|
EQ-5D-5L Index Score Over Time
End of Study
|
0.19 Scores on a scale
Interval 0.16 to 0.23
|
0.18 Scores on a scale
Interval 0.14 to 0.22
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127 and End of StudyPopulation: PD Analysis Set
Pain intensity is assessed by a Visual Analog Scale (VAS) which is measured on a 100mm line that represents a continuum between "no pain" and "worst pain". The scale range for pain score is 0-100, 0 being the best possible outcome (no pain) and 100 being the worst possible outcome (worst pain).
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Pain Score Over Time Using a VAS Scale
Day 15
|
-12.11 Scores on a scale
Interval -19.52 to -4.7
|
-9.50 Scores on a scale
Interval -17.3 to -1.71
|
|
Pain Score Over Time Using a VAS Scale
Day 29
|
-26.04 Scores on a scale
Interval -33.97 to -18.11
|
-23.13 Scores on a scale
Interval -31.52 to -14.74
|
|
Pain Score Over Time Using a VAS Scale
Day 57
|
-35.52 Scores on a scale
Interval -43.67 to -27.37
|
-32.83 Scores on a scale
Interval -41.52 to -24.15
|
|
Pain Score Over Time Using a VAS Scale
Day 85
|
-42.63 Scores on a scale
Interval -50.88 to -34.38
|
-37.97 Scores on a scale
Interval -46.74 to -29.21
|
|
Pain Score Over Time Using a VAS Scale
Day 99
|
-46.11 Scores on a scale
Interval -54.1 to -38.12
|
-40.56 Scores on a scale
Interval -49.0 to -32.11
|
|
Pain Score Over Time Using a VAS Scale
Day 127
|
-49.44 Scores on a scale
Interval -57.45 to -41.44
|
-45.27 Scores on a scale
Interval -53.75 to -36.79
|
|
Pain Score Over Time Using a VAS Scale
End of Study
|
-52.23 Scores on a scale
Interval -60.31 to -44.14
|
-50.74 Scores on a scale
Interval -59.4 to -42.08
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127 and End of StudyPopulation: PD Analysis Set
The patient's global assessment of disease activity is performed using a 100 mm Visual Analog Scale (VAS) ranging from "no activity" to "most active" in the last 24 hours. The scale range for PGA score is 0-100, 0 being the best possible outcome (no disease activity) and 100 being the worst possible outcome (maximal disease activity).
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 15
|
-6.33 Scores on a scale
Interval -13.44 to 0.79
|
-8.09 Scores on a scale
Interval -15.79 to -0.38
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 29
|
-22.25 Scores on a scale
Interval -29.68 to -14.82
|
-16.38 Scores on a scale
Interval -24.43 to -8.33
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 57
|
-29.40 Scores on a scale
Interval -37.06 to -21.74
|
-25.69 Scores on a scale
Interval -34.04 to -17.34
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 85
|
-37.57 Scores on a scale
Interval -45.01 to -30.12
|
-31.75 Scores on a scale
Interval -39.79 to -23.72
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 99
|
-38.43 Scores on a scale
Interval -45.88 to -30.97
|
-35.10 Scores on a scale
Interval -43.14 to -27.07
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
Day 127
|
-43.78 Scores on a scale
Interval -51.23 to -36.33
|
-38.32 Scores on a scale
Interval -46.37 to -30.26
|
|
Patient Global Assessment (PGA) Score Over Time Using a VAS Scale
End of Study
|
-47.72 Scores on a scale
Interval -55.15 to -40.28
|
-39.43 Scores on a scale
Interval -47.45 to -31.4
|
SECONDARY outcome
Timeframe: Days 15, 29, 57, 85, 99, 127 and End of StudyPopulation: PD Analysis Set
Physician global assessment (PhGA) score using a VAS scale (considering the last 24 hours). The scale range for PhGA score is 0-100, 0 being the best possible outcome (no disease activity) and 100 being the worst possible outcome (maximal disease activity).
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 57
|
-30.78 Score on a scale
Interval -37.57 to -23.99
|
-27.83 Score on a scale
Interval -35.13 to -20.53
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 15
|
-13.99 Score on a scale
Interval -20.22 to -7.75
|
-9.11 Score on a scale
Interval -15.8 to -2.42
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 29
|
-25.01 Score on a scale
Interval -31.51 to -18.5
|
-19.42 Score on a scale
Interval -26.42 to -12.43
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 85
|
-33.42 Score on a scale
Interval -40.68 to -26.16
|
-37.88 Score on a scale
Interval -45.66 to -30.11
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 99
|
-35.72 Score on a scale
Interval -42.66 to -28.79
|
-41.73 Score on a scale
Interval -49.15 to -34.31
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
Day 127
|
-41.72 Score on a scale
Interval -48.32 to -35.12
|
-44.18 Score on a scale
Interval -51.28 to -37.08
|
|
Physician Global Assessment (PhGA) Score Using a VAS Scale Over Time
End of Study
|
-44.64 Score on a scale
Interval -51.86 to -37.41
|
-44.26 Score on a scale
Interval -52.02 to -36.51
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and EoS (End of Study)Population: PD Analysis Set
Mean trough concentrations Cmin is a pharmacokinetics term for the minimum blood plasma concentration reached by a drug prior to administration of a second dose (mass/volume) Serum trough concentrations of secukinumab 300 mg group was measured at Days 1, 29, 85 and EoS
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
Placebo s.c.
|
|---|---|---|
|
Pharmacokinetics - Cmin
Mean trough concentration after first 4 wkly doses
|
90.4 ug/mL
Standard Deviation 30.7
|
—
|
|
Pharmacokinetics - Cmin
Week 12
|
13.2 ug/mL
Standard Deviation 6.67
|
—
|
SECONDARY outcome
Timeframe: Day 1 and EoSPopulation: PD Analysis Set
Number of Participants with Treatment emergent Anti-secukinumab antibodies
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Immunogenicity Assessment - Treatment Emergent ADAs
Day 1
|
0 Participants
|
1 Participants
|
|
Immunogenicity Assessment - Treatment Emergent ADAs
End of Study
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 99Population: PD Analysis Set
Assessment of structural changes in the rotator cuff tendinopathy over time The MRI Sein score was used to grade supraspinatus tendinosis using a modified 4-point scale from 0 to 3 and changes in grading over time were captured in the shift table. Grade 0 is normal, grade 1 is mild, Grade 2 is moderate and grade 3 is marked tendinosis. In this Sein score assessment, only data from Day 99 and baseline could be compared, as only those two time points were double read and adjudicated in case the 2 readers had different results. At any other time-points (Day 57 and EOS), images were assessed only by one reader and thus could not be compared to baseline.
Outcome measures
| Measure |
Secukinumab
n=47 Participants
AIN457 300 mg subcutaneously (s.c.)
|
Placebo
n=41 Participants
Placebo s.c.
|
|---|---|---|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Baseline grade 1
|
31 participants
|
25 participants
|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Baseline grade 2
|
11 participants
|
10 participants
|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Baseline grade 3
|
3 participants
|
3 participants
|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Day 99 grade 1
|
31 participants
|
26 participants
|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Day 99 grade 2
|
11 participants
|
9 participants
|
|
Number of Participants With Tendinosis Grade Score 1, 2 or 3 Measured by Magnetic Resonance Imaging (MRI) Sein Scores
Day 99 grade 3
|
3 participants
|
3 participants
|
Adverse Events
AIN457 300 mg s.c.
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AIN457 300 mg s.c.
n=49 participants at risk
AIN457 300 mg
|
Placebo
n=47 participants at risk
Placebo s.c.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.1%
3/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Faeces soft
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Nausea
|
12.2%
6/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
10.6%
5/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Chest pain
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Fatigue
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
4.3%
2/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Feeling hot
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Influenza like illness
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Injection site erythema
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
4.3%
2/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Injection site haematoma
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Injection site pain
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Injection site paraesthesia
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Injection site pruritus
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Acute sinusitis
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Cellulitis
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Fungal infection
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Fungal skin infection
|
6.1%
3/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Gastroenteritis
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Gastrointestinal viral infection
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Lymphangitis
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Nasopharyngitis
|
16.3%
8/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
10.6%
5/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Oral herpes
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Periodontitis
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Pustule
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Rhinitis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
4.3%
2/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
8.5%
4/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
4.3%
2/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
8.5%
4/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
3/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
3/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Headache
|
14.3%
7/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
14.9%
7/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Somnolence
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Psychiatric disorders
Phonophobia
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Keratolysis exfoliativa acquired
|
0.00%
0/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
2.1%
1/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.0%
1/49 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/47 • Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
|
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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER