Trial Outcomes & Findings for Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective (NCT NCT01362608)
NCT ID: NCT01362608
Last Updated: 2017-06-08
Results Overview
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
at 72 hours post-dose
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
ACZ885 150 mg
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
63
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
ACZ885 150 mg
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
Baseline characteristics by cohort
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 11.98 • n=99 Participants
|
49.2 years
STANDARD_DEVIATION 11.37 • n=107 Participants
|
49.7 years
STANDARD_DEVIATION 11.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at 72 hours post-dosePopulation: Full Analysis set
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
|
18.2 units on a scale
Standard Error 3.03
|
37.9 units on a scale
Standard Error 3.03
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
|
5 Participants
95% Confidence Interval 3.03 • Interval 1.19 to 13.93
|
17 Participants
95% Confidence Interval 3.03 • Interval 15.29 to 36.71
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
The Number of Patients With at Least 1 New Gout Flare
1 new flare
|
3 participants
|
15 participants
|
|
The Number of Patients With at Least 1 New Gout Flare
2 new flares
|
0 participants
|
1 participants
|
|
The Number of Patients With at Least 1 New Gout Flare
3 new flares
|
0 participants
|
0 participants
|
|
The Number of Patients With at Least 1 New Gout Flare
> 3 new flares
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: Full Analysis set
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
baseline
|
72.3 unit on a scale
Standard Deviation 13.18
|
74.5 unit on a scale
Standard Deviation 12.88
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
6 hours post-dose
|
53.0 unit on a scale
Standard Deviation 22.06
|
58.8 unit on a scale
Standard Deviation 23.83
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
12 hours post-dose
|
41.7 unit on a scale
Standard Deviation 19.56
|
51.8 unit on a scale
Standard Deviation 27.07
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
24 hours post-dose
|
30.9 unit on a scale
Standard Deviation 18.23
|
48.6 unit on a scale
Standard Deviation 29.13
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
48 hours post-dose
|
22.0 unit on a scale
Standard Deviation 18.64
|
43.9 unit on a scale
Standard Deviation 30.69
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
72 hours post-dose
|
17.4 unit on a scale
Standard Deviation 17.02
|
36.6 unit on a scale
Standard Deviation 30.62
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
7 days post-dose
|
10.1 unit on a scale
Standard Deviation 15.61
|
24.0 unit on a scale
Standard Deviation 27.31
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
4 weeks post-dose
|
9.5 unit on a scale
Standard Deviation 17.25
|
17.9 unit on a scale
Standard Deviation 25.31
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
8 weeks post-dose
|
6.8 unit on a scale
Standard Deviation 13.64
|
16.0 unit on a scale
Standard Deviation 24.24
|
|
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
12 weeks post-dose
|
6.8 unit on a scale
Standard Deviation 12.92
|
13.0 unit on a scale
Standard Deviation 19.77
|
SECONDARY outcome
Timeframe: baseline through week 12Population: Full Analysis Set
Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
6 hours post-dose mild
|
18 participants
|
14 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
baseline none
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
baseline mild
|
2 participants
|
3 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
baseline moderate
|
25 participants
|
18 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
baseline severe
|
37 participants
|
44 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
baseline extreme
|
3 participants
|
4 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
6 hours post-dose none
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
6 hours post-dose moderate
|
28 participants
|
26 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
6 hours post-dose severe
|
17 participants
|
29 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
6 hours post-dose extreme
|
2 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 hours post-dose none
|
1 participants
|
2 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 hours post-dose mild
|
28 participants
|
19 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 hours post-dose moderate
|
28 participants
|
26 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 hours post-dose severe
|
7 participants
|
21 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 hours post-dose extreme
|
1 participants
|
1 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
24 hours post-dose none
|
3 participants
|
4 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
24 hours post-dose mild
|
40 participants
|
20 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
24 hours post-dose moderate
|
19 participants
|
25 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
24 hours post-dose severe
|
2 participants
|
20 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
24 hours post-dose extreme
|
1 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
48 hours post-dose none
|
10 participants
|
10 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
48 hours post-dose mild
|
48 participants
|
21 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
48 hours post-dose moderate
|
7 participants
|
20 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
48 hours post-dose severe
|
2 participants
|
14 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
48 hours post-dose extreme
|
0 participants
|
2 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
72 hours post-dose none
|
14 participants
|
12 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
72 hours post-dose mild
|
45 participants
|
26 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
72 hours post-dose moderate
|
8 participants
|
16 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
72 hours post-dose severe
|
0 participants
|
9 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
72 hours post-dose extreme
|
0 participants
|
4 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 days post-dose none
|
21 participants
|
14 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 days post-dose mild
|
39 participants
|
29 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 days post-dose moderate
|
7 participants
|
13 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 days post-dose severe
|
0 participants
|
10 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 days post-dose extreme
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
7 days post-dose none
|
32 participants
|
23 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
7 days post-dose mild
|
29 participants
|
25 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
7 days post-dose moderate
|
5 participants
|
10 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
7 days post-dose severe
|
1 participants
|
8 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
7 days post-dose extreme
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 weeks post-dose none
|
43 participants
|
24 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 weeks post-dose mild
|
17 participants
|
25 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 weeks post-dose moderate
|
4 participants
|
6 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 weeks post-dose severe
|
1 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
4 weeks post-dose extreme
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
8 weeks post-dose none
|
39 participants
|
30 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
8 weeks post-dose mild
|
22 participants
|
21 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
8 weeks post-dose moderate
|
2 participants
|
6 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
8 weeks post-dose severe
|
2 participants
|
2 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
8 weeks post-dose extreme
|
0 participants
|
0 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 weeks post-dose none
|
41 participants
|
25 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 weeks post-dose mild
|
18 participants
|
28 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 weeks post-dose moderate
|
3 participants
|
8 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 weeks post-dose severe
|
2 participants
|
1 participants
|
|
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
12 weeks post-dose extreme
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 72 hours through week 12Population: Full Analysis Set
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose excellent
|
7 participants
|
3 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose good
|
40 participants
|
17 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose acceptable
|
14 participants
|
18 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose slight
|
4 participants
|
11 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose poor
|
1 participants
|
10 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose very poor
|
0 participants
|
0 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
72 hours post-dose not done
|
0 participants
|
1 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose excellent
|
16 participants
|
4 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose good
|
38 participants
|
20 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose acceptable
|
9 participants
|
18 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose slight
|
1 participants
|
7 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose poor
|
1 participants
|
16 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose very poor
|
0 participants
|
0 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
7 days post-dose not done
|
0 participants
|
1 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose excellent
|
15 participants
|
6 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose good
|
33 participants
|
19 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose acceptable
|
13 participants
|
14 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose slight
|
4 participants
|
7 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose poor
|
0 participants
|
9 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose very poor
|
0 participants
|
0 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
4 weeks post-dose not done
|
0 participants
|
2 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose excellent
|
18 participants
|
8 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose good
|
35 participants
|
16 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose acceptable
|
10 participants
|
18 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose slight
|
2 participants
|
9 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose poor
|
0 participants
|
8 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose very poor
|
0 participants
|
0 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
8 weeks post-dose not done
|
0 participants
|
1 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose excellent
|
16 participants
|
4 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose good
|
37 participants
|
21 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose acceptable
|
10 participants
|
21 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose slight
|
0 participants
|
7 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose poor
|
1 participants
|
9 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose very poor
|
0 participants
|
0 participants
|
|
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
12 weeks post-dose not done
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dosePopulation: Full analysis set
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
72 hours post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
72 hours post-dose pain, winces and withdraws
|
1 participants
|
3 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Baseline no pain
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Baseline pain
|
15 participants
|
16 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Baseline pain and winces
|
31 participants
|
29 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Baseline pain, winces and withdraws
|
21 participants
|
24 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Baseline not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
72 hours post-dose no pain
|
23 participants
|
16 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
72 hours post-dose pain
|
37 participants
|
26 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
72 hours post-dose pain and winces
|
5 participants
|
11 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
7 days post-dose no pain
|
41 participants
|
26 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
7 days post-dose pain
|
23 participants
|
27 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
7 days post-dose pain and winces
|
2 participants
|
10 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
7 days post-dose pain , winces and withdraws
|
0 participants
|
2 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
7 days post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
4 weeks post-dose no pain
|
54 participants
|
30 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
4 weeks post-dose pain
|
10 participants
|
19 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
4 weeks post-dose pain and winces
|
1 participants
|
3 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
4 weeks post-dose pain, winces and withdraws
|
0 participants
|
3 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
4 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
8 weeks post-dose no pain
|
54 participants
|
38 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
8 weeks post-dose pain
|
11 participants
|
19 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
8 weeks post-dose pain and winces
|
0 participants
|
1 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
8 weeks post-dose pain winces and withdraws
|
0 participants
|
1 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
8 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
12 weeks post-dose no pain
|
53 participants
|
39 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
12 weeks post-dose pain
|
7 participants
|
22 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
12 weeks post-dose pain and winces
|
2 participants
|
1 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
12 weeks post-dose pain, winces and withdraws
|
2 participants
|
0 participants
|
|
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
12 weeks post-dose not assessed
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dosePopulation: Full analysis set
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
12 weeks post-dose Palpable
|
1 participants
|
6 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Baseline No swelling
|
1 participants
|
3 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Baseline Palpable
|
13 participants
|
12 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Baseline Visible
|
29 participants
|
39 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Baseline Bulging beyond the joint margins
|
24 participants
|
15 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Baseline not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
72 hours post-dose No swelling
|
38 participants
|
22 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
72 hours post-dose Palpable
|
15 participants
|
15 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
72 hours post-dose Visible
|
12 participants
|
18 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
72 hrs post-dose Bulging beyond the joint margins
|
1 participants
|
1 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
72 hours post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
7 days post-dose No swelling
|
53 participants
|
35 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
7 days post-dose Palpable
|
9 participants
|
18 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
7 days post-dose Visible
|
3 participants
|
9 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
7 days post-dose Bulging beyond the joint margins
|
1 participants
|
3 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
7 days post-dose not assessed0
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
4 weeks post-dose No swelling
|
60 participants
|
40 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
4 weeks post-dose Palpable
|
2 participants
|
9 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
4 weeks post-dose Visible
|
3 participants
|
4 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
4 weeks post-dose Bulging beyond the joint margins
|
0 participants
|
2 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
4 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
8 weeks post-dose No swelling
|
63 participants
|
49 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
8 weeks post-dose Palpable
|
0 participants
|
6 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
8 weeks post-dose Visible
|
2 participants
|
4 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
8 weeks post-dose Bulging beyond the joint margins
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
8 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
12 weeks post-dose No swelling
|
61 participants
|
52 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
12 weeks post-dose Visible
|
2 participants
|
2 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
12 wks post-dose Bulging beyond the joint margins
|
0 participants
|
2 participants
|
|
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
12 weeks post-dose not assessed
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dosePopulation: Full analysis set
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Baseline Absent
|
19 participants
|
19 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Baseline present
|
48 participants
|
50 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Baseline not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Baseline not assessable
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
72 hours post-dose absent
|
54 participants
|
41 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
72 hours post-dose present
|
11 participants
|
15 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
72 hours post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
72 hrs post-dose not assessable
|
1 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
7 days post-dose absent
|
62 participants
|
57 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
7 days post-dose present
|
3 participants
|
8 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
7 days post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
7 days post-dose not assessable
|
1 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
4 weeks post-dose absent
|
63 participants
|
49 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
4 weeks post-dose present
|
1 participants
|
6 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
4 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
4 weeks post-dose not assessable
|
1 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
8 weeks post-dose absent
|
65 participants
|
56 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
8 weeks post-dose present
|
0 participants
|
3 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
8 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
8 weeks post-dose not assessable
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
12 weeks post-dose absent
|
62 participants
|
61 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
12 weeks post-dose present
|
1 participants
|
1 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
12 weeks post-dose not assessed
|
0 participants
|
0 participants
|
|
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
12 wks post-dose not assessable
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline through week 12Population: Full Analysis Set
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
baseline normal
|
0 participants
|
0 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
baseline mildly restricted
|
3 participants
|
6 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
baseline moderately restricted
|
32 participants
|
24 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
baseline severely restricted
|
27 participants
|
39 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
baseline immobilzed
|
5 participants
|
0 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
72 hours post-dose normal
|
20 participants
|
15 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
72 hours post-dose mildly restricted
|
33 participants
|
19 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
72 hours post-dose moderately restricted
|
11 participants
|
14 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
72 hours post-dose severely restricted
|
2 participants
|
7 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
72 hours post-dose immobilized
|
0 participants
|
1 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
7 days post-dose normal
|
35 participants
|
26 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
7 days post-dose mildly restricted
|
25 participants
|
20 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
7 days post-dose moderately restricted
|
4 participants
|
15 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
7 days post-dose severely restricted
|
1 participants
|
3 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
7 days post-dose immobilized
|
0 participants
|
1 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
4 weeks post-dose normal
|
49 participants
|
25 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
4 weeks post-dose mildly restricted
|
12 participants
|
22 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
4 weeks post-dose moderately restricted
|
3 participants
|
7 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
4 weeks post-dose severely restricted
|
1 participants
|
1 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
4 weeks post-dose immobilized
|
0 participants
|
0 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
8 weeks post-dose normal
|
51 participants
|
32 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
8 weeks post-dose mildly restricted
|
12 participants
|
18 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
8 weeks post-dose moderately restricted
|
1 participants
|
6 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
8 weeks post-dose severely restricted
|
1 participants
|
3 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
8 weeks post-dose immobilized
|
0 participants
|
0 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
12 weeks post-dose normal
|
50 participants
|
30 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
12 weeks post-dose mildly restrcted
|
1 participants
|
23 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
12 weeks post-dose moderately restricted
|
2 participants
|
6 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
12 weeks post-dose severely restricted
|
1 participants
|
3 participants
|
|
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
12 weeks post-dose immobilized
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set
Kaplan Meier estimate
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
|
24.0 hours
Interval 24.0 to 48.0
|
48.0 hours
Interval 24.0 to 72.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set
Kaplan Meier estimate
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Time to Complete Resolution of Pain: Survival Analysis by Treatment
|
168.0 hours
Interval 120.0 to 168.0
|
168.0 hours
CI cannot calculated for this parameter as it is "too narrow to exist". The CI limits are time points where events happened or censored. When we decrease the confidence level from 99% to 95%, no observed time point meets the criterion.
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Time to First Rescue Medication Intake
|
31.8 hours
Standard Deviation 30.45
|
41.5 hours
Standard Deviation 38.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Percent Patients Who Took Rescue Medication
Baseline flare (n= 29,42)
|
43.3 percentage
|
60.9 percentage
|
|
Percent Patients Who Took Rescue Medication
Last post-baseline flare (n=3,4)
|
75.0 percentage
|
44.4 percentage
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
Outcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Baseline flare Prednisolol
|
1.1 mg
Standard Deviation 4.25
|
5.0 mg
Standard Deviation 15.29
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Baseline Flare Prednisone
|
0.7 mg
Standard Deviation 5.52
|
5.2 mg
Standard Deviation 30.42
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Baseline flare Codeine
|
0.0 mg
Standard Deviation 0.00
|
0.4 mg
Standard Deviation 3.61
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Last post-baseline flare Paraceta/acetamin n=4,9
|
287.5 mg
Standard Deviation 337.58
|
222.2 mg
Standard Deviation 666.67
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Last post-baseline flare Prednisolone n=4,9
|
5.0 mg
Standard Deviation 10.00
|
4.4 mg
Standard Deviation 8.82
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Last post-baseline flare Prednisone n=4,9
|
0.0 mg
Standard Deviation 0.00
|
0.6 mg
Standard Deviation 1.67
|
|
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Baseline flare Paracetamol / acetaminophen
|
342.5 mg
Standard Deviation 680.53
|
451.4 mg
Standard Deviation 744.19
|
SECONDARY outcome
Timeframe: 72 hours post doseOutcome measures
| Measure |
ACZ885 150 mg
n=67 Participants
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
|
Triamcinolone Acetonide 40 mg
n=69 Participants
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
|
|---|---|---|
|
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
|
5.5 mg/L
Interval 4.4 to 6.9
|
7.2 mg/L
Interval 5.7 to 9.2
|
Adverse Events
ACZ885 150mg sc
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triam 40mg im
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACZ885 150mg sc
n=67 participants at risk
ACZ885 150mg sc
|
Triam 40mg im
n=69 participants at risk
Triam 40mg im
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/67
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/67
|
1.4%
1/69
|
Other adverse events
| Measure |
ACZ885 150mg sc
n=67 participants at risk
ACZ885 150mg sc
|
Triam 40mg im
n=69 participants at risk
Triam 40mg im
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/67
|
5.8%
4/69
|
Additional Information
Clinical Disclosure Office
Novartis
Phone: 862-778-8300
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER