Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00927810
Collaborator
(none)
341
45
1
14
7.6
0.5
Study Details
Study Description
Brief Summary
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
341 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
Actual Study Start Date
:
Jun 5, 2009
Actual Primary Completion Date
:
Aug 4, 2010
Actual Study Completion Date
:
Aug 4, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: canakinumab
|
Drug: Canakinumab
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events and Serious Adverse Events [From start of study up to study completion (up to 14 months)]
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
Secondary Outcome Measures
- Difference Change From Baseline in Participant's Gout Pain During First Flare [Baseline and Day 7]
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
- Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category [24 weeks]
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
- Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category [24 weeks]
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
- Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group [24 weeks]
Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
- Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group [24 weeks]
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
-
Patients who have signed a written informed consent before any trial procedure is performed.
Exclusion Criteria:
-
Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
-
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
-
Female patients who were physiologically capable of becoming pregnant, unless they were:
-
Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
-
Female patients whose partners had been sterilized by vasectomy or other means.
-
Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
-
Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative site | Seattle | Washington | United States | 98101 |
| 2 | Novartis Investigative site | Capital Federal Buenos Aires | Argentina | 1027 | |
| 3 | Novartis Investigative site | Jette | Belgium | 1090 | |
| 4 | Novartis Investigative site | Barranquilla | Colombia | ||
| 5 | Novartis Investigative site | Bogotá | Colombia | ||
| 6 | Novartis Investigative site | Bucaramanga | Colombia | ||
| 7 | Novartis Investigative site | Floridablanca | Colombia | ||
| 8 | Novartis Investigative site | Praha 5 | Czech Republic | Czechia | 15006 |
| 9 | Novartis Investigative site | Sachsen | Dresden / Schützenhöhe 16 | Germany | D-01099 |
| 10 | Novartis Investigative site | Bayern | München / Mühlbaurstraße 16 | Germany | D-81677 |
| 11 | Novartis Investigative site | Dessau | Roßlau / Kühnauer Straße 70 Sachsen- Anhalt | Germany | D-06846 |
| 12 | Novartis Investigative site | Guatemala City | Guatemala | 01015 | |
| 13 | Novartis Investigative site | Debrecen | Bartók B U 2-26 | Hungary | 4043 |
| 14 | Novartis Investigative site | Kistarcsa | Semmelweis Tér 1. | Hungary | 2143 |
| 15 | Novartis Investigative site | Eger | Széchenyi U 27-29 | Hungary | 3301 |
| 16 | Novartis Investigative site | Zalaegerszeg | Zrínyi U 1 | Hungary | 8900 |
| 17 | Novartis Investigative site | Poznań | Poland | NA 61- 734 | |
| 18 | Novartis Investigative site | Wrocław | Poland | NA 50-333 | |
| 19 | Novartis Investigative site | Lisboa | Portugal | 1749-004 | |
| 20 | Novartis Investigative site | Chelyabinsk | Russian Federation | 454047 | |
| 21 | Novartis Investigative site | Moscow | Russian Federation | 115522 | |
| 22 | Novartis Investigative site | Moscow | Russian Federation | 127473 | |
| 23 | Novartis Investigative site | Petrozavodsk | Russian Federation | ||
| 24 | Novartis Investigative site | Saint Petersburg | Russian Federation | 190068 | |
| 25 | Novartis Investigative site | Saint Petersburg | Russian Federation | 193015 | |
| 26 | Novartis Investigative site | Yaroslavl | Russian Federation | 150003 | |
| 27 | Novartis Investigative site | Singapore | Singapore | 169611 | |
| 28 | Novartis Investigative site | Bratislava | Slovakia | N/A 813 69 | |
| 29 | Novartis Investigative site | Košice | Slovakia | N/A 042 66 | |
| 30 | Novartis Investigative site | Nitra | Slovakia | N/A 949 01 | |
| 31 | Novartis Investigative site | Piešťany | Slovakia | N/A 921 12 | |
| 32 | Novartis Investigative site | Trenčín | Slovakia | N/A 911 50 | |
| 33 | Novartis Investigative site | Pretoria | Gauteng | South Africa | 0153 |
| 34 | Novartis Investigative site | Madrid | Spain | 28046 | |
| 35 | Novartis Investigative site | Kaohsiung | Taiwan | 80756 | |
| 36 | Novartis Investigative site | Kaohsiung | Taiwan | 81346 | |
| 37 | Novartis Investigative site | Taichung | Taiwan | 40705 | |
| 38 | Novartis Investigative site | Taipei | Taiwan | 11217 | |
| 39 | Novartis Investigative site | Ankara | Bahcellievler | Turkey | 06490 |
| 40 | Novartis Investigative site | Adana | Balcali | Turkey | 01330 |
| 41 | Novartis Investigative site | İzmir | Inciraltı | Turkey | 35340 |
| 42 | Novartis Investigative site | Aydın | Merkez | Turkey | 09100 |
| 43 | Novartis Investigative site | Manisa | Merkez | Turkey | 45010 |
| 44 | Novartis Investigative site | Gaziantep | Sehitkamil | Turkey | 27310 |
| 45 | Novartis Investigative site | Jarrow | Tyne & Wear | United Kingdom | NE32 3DT |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00927810
Other Study ID Numbers:
- CACZ885H2251E1
First Posted:
Jun 25, 2009
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 75 centers in 18 countries. |
|---|---|
| Pre-assignment Detail | A total of 341 participants enrolled in the study, out of which 330 participants completed the study. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab |
|---|---|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single SC dose of 150 mg Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not receive canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Period Title: Overall Study | ||||
| STARTED | 75 | 181 | 25 | 60 |
| COMPLETED | 75 | 173 | 24 | 58 |
| NOT COMPLETED | 0 | 8 | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | Total of all reporting groups |
| Overall Participants | 75 | 181 | 25 | 60 | 341 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
50.7
(10.20)
|
53.8
(11.39)
|
52.0
(11.00)
|
51.5
(9.45)
|
52.6
(10.83)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
2
2.7%
|
13
7.2%
|
0
0%
|
7
11.7%
|
22
6.5%
|
| Male |
73
97.3%
|
168
92.8%
|
25
100%
|
53
88.3%
|
319
93.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| Caucasian |
46
61.3%
|
143
79%
|
19
76%
|
49
81.7%
|
257
75.4%
|
| Black |
2
2.7%
|
6
3.3%
|
1
4%
|
1
1.7%
|
10
2.9%
|
| Asian |
11
14.7%
|
10
5.5%
|
2
8%
|
2
3.3%
|
25
7.3%
|
| Native American |
1
1.3%
|
3
1.7%
|
0
0%
|
1
1.7%
|
5
1.5%
|
| Pacific islander |
0
0%
|
0
0%
|
0
0%
|
2
3.3%
|
2
0.6%
|
| Other |
15
20%
|
19
10.5%
|
3
12%
|
5
8.3%
|
42
12.3%
|
Outcome Measures
| Title | Number of Participants With Adverse Events and Serious Adverse Events |
|---|---|
| Description | Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards |
| Time Frame | From start of study up to study completion (up to 14 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set 1 consisted of all participants from the core study who entered the extension study. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab |
|---|---|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 75 | 181 | 25 | 60 |
| Count of Participants [Participants] |
31
41.3%
|
52
28.7%
|
9
36%
|
15
25%
|
| Title | Difference Change From Baseline in Participant's Gout Pain During First Flare |
|---|---|
| Description | Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported. |
| Time Frame | Baseline and Day 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 52 | 13 |
| Mean (Standard Deviation) [units on a scale] |
-51.7
(15.86)
|
-67.4
(21.69)
|
| Title | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category |
|---|---|
| Description | Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 63 | 21 |
| 1. Gout Flare: Excellent |
40
53.3%
|
7
3.9%
|
| 1. Gout Flare: Good |
17
22.7%
|
14
7.7%
|
| 1. Gout Flare: Acceptable |
5
6.7%
|
0
0%
|
| 1. Gout Flare: Slight |
1
1.3%
|
0
0%
|
| 1. Gout Flare: Poor |
0
0%
|
0
0%
|
| 2. Gout Flare: Excellent |
4
5.3%
|
4
2.2%
|
| 2. Gout Flare: Good |
6
8%
|
1
0.6%
|
| 2. Gout Flare: Acceptable |
1
1.3%
|
0
0%
|
| 2. Gout Flare: Slight |
0
0%
|
0
0%
|
| 2. Gout Flare: Poor |
0
0%
|
0
0%
|
| 3. Gout Flare: Excellent |
2
2.7%
|
0
0%
|
| 3. Gout Flare: Good |
1
1.3%
|
1
0.6%
|
| 3. Gout Flare: Acceptable |
0
0%
|
0
0%
|
| 3. Gout Flare: Slight |
0
0%
|
0
0%
|
| 3. Gout Flare: Poor |
0
0%
|
0
0%
|
| Title | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category |
|---|---|
| Description | Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 69 | 23 |
| 1. Gout Flare: Very Good |
37
49.3%
|
13
7.2%
|
| 1. Gout Flare: Good |
28
37.3%
|
10
5.5%
|
| 1. Gout Flare: Fair |
2
2.7%
|
0
0%
|
| 1. Gout Flare: Poor |
2
2.7%
|
0
0%
|
| 1. Gout Flare: Very Poor |
0
0%
|
0
0%
|
| 2. Gout Flare: Very good |
5
6.7%
|
3
1.7%
|
| 2. Gout Flare: Good |
7
9.3%
|
2
1.1%
|
| 2. Gout Flare: Fair |
0
0%
|
0
0%
|
| 2. Gout Flare: Poor |
0
0%
|
0
0%
|
| 2. Gout Flare: Very poor |
0
0%
|
0
0%
|
| 3. Gout Flare: Very Good |
1
1.3%
|
0
0%
|
| 3. Gout Flare: Good |
2
2.7%
|
1
0.6%
|
| 3. Gout Flare: Fair |
0
0%
|
0
0%
|
| 3. Gout Flare: Poor |
0
0%
|
0
0%
|
| 3. Gout Flare: Very poor |
0
0%
|
0
0%
|
| Title | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group |
|---|---|
| Description | Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 69 | 24 |
| Tenderness-Flare Visit- No pain |
2
2.7%
|
0
0%
|
| Tenderness-Control Visit- No pain |
60
80%
|
21
11.6%
|
| Joint swelling-Flare Visit-No swelling |
5
6.7%
|
0
0%
|
| Joint swelling-Control Visit-No swelling |
61
81.3%
|
22
12.2%
|
| Erythema-Flare Visit-Absent |
21
28%
|
4
2.2%
|
| Erythema-Control Visit-Absent |
66
88%
|
24
13.3%
|
| Title | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group |
|---|---|
| Description | The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure. |
| Arm/Group Title | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). |
| Measure Participants | 68 | 24 |
| 1.Gout flare-Naproxen |
1086.8
(1592.72)
|
954.6
(1130.19)
|
| 1.Gout flare-Prednisolone |
4.6
(20.84)
|
4.2
(20.41)
|
| 2.Gout flare-Naproxen |
650.0
(642.79)
|
200.0
(447.21)
|
| 2.Gout flare-Prednisolone |
1.3
(3.11)
|
0.0
(0.00)
|
| 3.Gout flare-Naproxen |
250.0
(500.00)
|
0.0
(0)
|
| 3.Gout flare-Prednisolone |
0.0
(0.00)
|
0.0
(0)
|
Adverse Events
| Time Frame | From start of study up to study completion (up to 14 months) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||
| Arm/Group Title | Core: Canakinumab 25 mg | Core: Canakinumab 50 mg | Core: Canakinumab 100 mg | Core: Canakinumab 200 mg | Core: Canakinumab 300 mg | Core : Canakinumab Q4wk mg | Core : Colchicine 0.5 mg | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | |||||||||||
| Arm/Group Description | Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks. | Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85. | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]). | Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]). | |||||||||||
All Cause Mortality |
||||||||||||||||||||||
| Core: Canakinumab 25 mg | Core: Canakinumab 50 mg | Core: Canakinumab 100 mg | Core: Canakinumab 200 mg | Core: Canakinumab 300 mg | Core : Canakinumab Q4wk mg | Core : Colchicine 0.5 mg | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 2/181 (1.1%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
Serious Adverse Events |
||||||||||||||||||||||
| Core: Canakinumab 25 mg | Core: Canakinumab 50 mg | Core: Canakinumab 100 mg | Core: Canakinumab 200 mg | Core: Canakinumab 300 mg | Core : Canakinumab Q4wk mg | Core : Colchicine 0.5 mg | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/55 (3.6%) | 2/54 (3.7%) | 3/54 (5.6%) | 3/54 (5.6%) | 3/53 (5.7%) | 1/53 (1.9%) | 6/108 (5.6%) | 4/75 (5.3%) | 6/181 (3.3%) | 0/25 (0%) | 1/60 (1.7%) | |||||||||||
| Cardiac disorders | ||||||||||||||||||||||
| Acute myocardial infarction | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Angina pectoris | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Myocardial fibrosis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Myocardial infarction | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Abdominal hernia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Abdominal pain | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Colitis ulcerative | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 1/53 (1.9%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Gastritis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Haemorrhoidal haemorrhage | 0/55 (0%) | 1/54 (1.9%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Inguinal hernia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Umbilical hernia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||||
| Cholelithiasis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Diverticulitis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Ear infection | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 1/53 (1.9%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Erysipelas | 1/55 (1.8%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Gangrene | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Pneumonia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 1/53 (1.9%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Sepsis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Tonsillitis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||
| Femur fracture | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Gun shot wound | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Hand fracture | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Heat exhaustion | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Incisional hernia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Ligament rupture | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 1/53 (1.9%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Meniscus lesion | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 1/60 (1.7%) | |||||||||||
| Radius fracture | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Tibia fracture | 1/55 (1.8%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Ulna fracture | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Gouty tophus | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Osteoarthritis | 0/55 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Tendonitis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||
| Prostate cancer | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 1/53 (1.9%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Renal cancer | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Nervous system disorders | ||||||||||||||||||||||
| Stupor | 0/55 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Transient ischaemic attack | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||
| Haematuria | 0/55 (0%) | 0/54 (0%) | 1/54 (1.9%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Nephrolithiasis | 0/55 (0%) | 1/54 (1.9%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Nephrotic syndrome | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Renal failure | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||
| Prostatitis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Vascular disorders | ||||||||||||||||||||||
| Deep vein thrombosis | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 0/53 (0%) | 0/108 (0%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||
| Core: Canakinumab 25 mg | Core: Canakinumab 50 mg | Core: Canakinumab 100 mg | Core: Canakinumab 200 mg | Core: Canakinumab 300 mg | Core : Canakinumab Q4wk mg | Core : Colchicine 0.5 mg | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | ||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/55 (38.2%) | 15/54 (27.8%) | 14/54 (25.9%) | 14/54 (25.9%) | 15/53 (28.3%) | 14/53 (26.4%) | 21/108 (19.4%) | 21/75 (28%) | 19/181 (10.5%) | 6/25 (24%) | 4/60 (6.7%) | |||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||
| Diarrhoea | 3/55 (5.5%) | 1/54 (1.9%) | 2/54 (3.7%) | 3/54 (5.6%) | 1/53 (1.9%) | 0/53 (0%) | 2/108 (1.9%) | 2/75 (2.7%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Nausea | 2/55 (3.6%) | 1/54 (1.9%) | 3/54 (5.6%) | 0/54 (0%) | 0/53 (0%) | 1/53 (1.9%) | 1/108 (0.9%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Infections and infestations | ||||||||||||||||||||||
| Nasopharyngitis | 5/55 (9.1%) | 2/54 (3.7%) | 2/54 (3.7%) | 0/54 (0%) | 0/53 (0%) | 3/53 (5.7%) | 1/108 (0.9%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 2/60 (3.3%) | |||||||||||
| Upper respiratory tract infection | 2/55 (3.6%) | 1/54 (1.9%) | 2/54 (3.7%) | 3/54 (5.6%) | 1/53 (1.9%) | 3/53 (5.7%) | 4/108 (3.7%) | 5/75 (6.7%) | 4/181 (2.2%) | 1/25 (4%) | 0/60 (0%) | |||||||||||
| Investigations | ||||||||||||||||||||||
| Alanine aminotransferase increased | 3/55 (5.5%) | 1/54 (1.9%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Aspartate aminotransferase increased | 3/55 (5.5%) | 1/54 (1.9%) | 0/54 (0%) | 1/54 (1.9%) | 0/53 (0%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 1/181 (0.6%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||
| Hypertriglyceridaemia | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 2/54 (3.7%) | 1/53 (1.9%) | 0/53 (0%) | 0/108 (0%) | 0/75 (0%) | 1/181 (0.6%) | 2/25 (8%) | 0/60 (0%) | |||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||
| Arthralgia | 4/55 (7.3%) | 5/54 (9.3%) | 4/54 (7.4%) | 2/54 (3.7%) | 3/53 (5.7%) | 2/53 (3.8%) | 3/108 (2.8%) | 4/75 (5.3%) | 6/181 (3.3%) | 0/25 (0%) | 1/60 (1.7%) | |||||||||||
| Back pain | 3/55 (5.5%) | 3/54 (5.6%) | 1/54 (1.9%) | 3/54 (5.6%) | 0/53 (0%) | 0/53 (0%) | 4/108 (3.7%) | 1/75 (1.3%) | 2/181 (1.1%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Nervous system disorders | ||||||||||||||||||||||
| Headache | 4/55 (7.3%) | 3/54 (5.6%) | 1/54 (1.9%) | 2/54 (3.7%) | 6/53 (11.3%) | 3/53 (5.7%) | 6/108 (5.6%) | 3/75 (4%) | 2/181 (1.1%) | 1/25 (4%) | 0/60 (0%) | |||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||
| Cough | 0/55 (0%) | 1/54 (1.9%) | 2/54 (3.7%) | 2/54 (3.7%) | 1/53 (1.9%) | 0/53 (0%) | 0/108 (0%) | 4/75 (5.3%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Sinus congestion | 0/55 (0%) | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) | 3/53 (5.7%) | 0/53 (0%) | 1/108 (0.9%) | 0/75 (0%) | 0/181 (0%) | 0/25 (0%) | 0/60 (0%) | |||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||
| Rash | 1/55 (1.8%) | 1/54 (1.9%) | 0/54 (0%) | 0/54 (0%) | 0/53 (0%) | 3/53 (5.7%) | 1/108 (0.9%) | 1/75 (1.3%) | 0/181 (0%) | 0/25 (0%) | 1/60 (1.7%) | |||||||||||
| Vascular disorders | ||||||||||||||||||||||
| Hypertension | 6/55 (10.9%) | 2/54 (3.7%) | 2/54 (3.7%) | 5/54 (9.3%) | 4/53 (7.5%) | 2/53 (3.8%) | 1/108 (0.9%) | 6/75 (8%) | 3/181 (1.7%) | 2/25 (8%) | 0/60 (0%) | |||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | +1 (862) 778-8300 |
| novartis.email@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00927810
Other Study ID Numbers:
- CACZ885H2251E1
First Posted:
Jun 25, 2009
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021