A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Study Details
Study Description
Brief Summary
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AIN457 1x25mg
|
Drug: AIN457
|
| Experimental: AIN457 3x25mg
|
Drug: AIN457
|
| Experimental: AIN457 3x75mg
|
Drug: AIN457
|
| Experimental: AIN457 3x150mg
|
Drug: AIN457
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 [week 13]
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Secondary Outcome Measures
- Percentage of Participants With Investigator's Global Assessment (IGA) Response [Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37]
IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) [Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37]
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
- To Assess the Time to Relapse [37 weeks]
Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At randomization, moderate to severe psoriasis as defined by:
-
PASI score of 12 or greater and,
-
IGA score of 3 or greater and,
-
Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Exclusion Criteria:
-
Forms of psoriasis other than chronic plaque-type
-
Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
-
Previous exposure to AIN457
-
Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
-
Known immunosuppression (e.g., AIDS) at screening and / or randomization
-
History or evidence of active tuberculosis at screening
-
Active systemic infections (other than common cold)
-
History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
-
Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
-
Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
-
Inability or unwillingness to undergo repeated venipuntures
-
History or evidence of drug or alcohol abuse
-
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | San Diego | California | United States | 92123 |
| 2 | Novartis Investigative Site | Louisville | Kentucky | United States | 40217 |
| 3 | Novartis Investigative Site | Rochester | New York | United States | 14623 |
| 4 | Novartis Investigative Site | Lake Oswego | Oregon | United States | 97035 |
| 5 | Novartis Investigative Site | Portland | Oregon | United States | 97210 |
| 6 | Novartis Investigative Site | Halifax | Nova Scotia | Canada | B3H 1Z2 |
| 7 | Novartis Investigative Site | North Bay | Ontario | Canada | P1B 3Z7 |
| 8 | Novartis Investigative Site | Waterloo | Ontario | Canada | N2J 1C4 |
| 9 | Novartis Investigative Site | Tallinn | Estonia | 10138 | |
| 10 | Novartis Investigative Site | Tallinn | Estonia | 13419 | |
| 11 | Novartis Investigative Site | Tartu | Estonia | 51014 | |
| 12 | Novartis Investigative Site | Kopavogur | Iceland | IS-201 | |
| 13 | Novartis Investigative Site | Nagoya-city | Aichi | Japan | 467-8602 |
| 14 | Novartis Investigative Site | Maebashi-city | Gunma | Japan | 371-8511 |
| 15 | Novartis Investigative Site | Sapporo-city | Hokkaido | Japan | 060-0063 |
| 16 | Novartis Investigative Site | Saitama-city | Saitama | Japan | 330-0854 |
| 17 | Novartis Investigative Site | Riga | Latvia | 1012 | |
| 18 | Novartis Investigative Site | Riga | Latvia | LV-1001 | |
| 19 | Novartis Investigative Site | Riga | Latvia |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CAIN457A2220
- 2009-016807-42
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Period Title: Overall Study | |||||
| STARTED | 29 | 26 | 21 | 27 | 22 |
| COMPLETED | 14 | 16 | 17 | 20 | 11 |
| NOT COMPLETED | 15 | 10 | 4 | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Total of all reporting groups |
| Overall Participants | 29 | 26 | 21 | 27 | 22 | 125 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
46.1
(12.65)
|
46.3
(13.43)
|
45.8
(12.36)
|
45.4
(11.64)
|
45.9
(10.88)
|
45.9
(12.07)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
9
31%
|
4
15.4%
|
7
33.3%
|
6
22.2%
|
8
36.4%
|
34
27.2%
|
| Male |
20
69%
|
22
84.6%
|
14
66.7%
|
21
77.8%
|
14
63.6%
|
91
72.8%
|
Outcome Measures
| Title | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 |
|---|---|
| Description | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). |
| Time Frame | week 13 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. |
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Measure Participants | 29 | 26 | 21 | 27 | 22 |
| Number [percentage of participants] |
3.4
11.7%
|
19.2
73.8%
|
57.1
271.9%
|
81.5
301.9%
|
9.1
41.4%
|
| Title | Percentage of Participants With Investigator's Global Assessment (IGA) Response |
|---|---|
| Description | IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline. |
| Time Frame | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. |
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Measure Participants | 29 | 26 | 21 | 27 | 22 |
| Week 2 |
0
0%
|
0
0%
|
0
0%
|
3.7
13.7%
|
0
0%
|
| Week 3 |
0
0%
|
0
0%
|
0
0%
|
3.7
13.7%
|
0
0%
|
| Week 5 |
0
0%
|
3.8
14.6%
|
4.8
22.9%
|
7.4
27.4%
|
0
0%
|
| Week 9 |
0
0%
|
7.7
29.6%
|
28.6
136.2%
|
37
137%
|
9.1
41.4%
|
| Week 13 |
0
0%
|
11.5
44.2%
|
33.3
158.6%
|
48.1
178.1%
|
9.1
41.4%
|
| Week 17 |
3.4
11.7%
|
19.2
73.8%
|
28.6
136.2%
|
51.9
192.2%
|
9.1
41.4%
|
| Week 21 |
0
0%
|
19.2
73.8%
|
38.1
181.4%
|
40.7
150.7%
|
13.6
61.8%
|
| Week 25 |
0
0%
|
15.4
59.2%
|
33.3
158.6%
|
37
137%
|
18.2
82.7%
|
| Week 29 |
0
0%
|
11.5
44.2%
|
19.0
90.5%
|
40.7
150.7%
|
13.6
61.8%
|
| Week 33 |
0
0%
|
15.4
59.2%
|
19.0
90.5%
|
29.6
109.6%
|
0
0%
|
| Week 37 |
0
0%
|
15.4
59.2%
|
9.5
45.2%
|
25.9
95.9%
|
0
0%
|
| Title | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) |
|---|---|
| Description | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). |
| Time Frame | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. |
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Measure Participants | 29 | 26 | 21 | 27 | 22 |
| Week 2 PASI 50 |
3.4
11.7%
|
7.7
29.6%
|
4.8
22.9%
|
11.1
41.1%
|
0
0%
|
| Week 2 PASI 75 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2 PASI 90 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 3 PASI 50 |
3.4
11.7%
|
7.7
29.6%
|
23.8
113.3%
|
18.5
68.5%
|
4.5
20.5%
|
| Week 3 PASI 75 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 3 PASI 90 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 5 PASI 50 |
10.3
35.5%
|
15.4
59.2%
|
28.6
136.2%
|
48.1
178.1%
|
4.5
20.5%
|
| Week 5 PASI 75 |
0
0%
|
7.7
29.6%
|
4.8
22.9%
|
14.8
54.8%
|
4.5
20.5%
|
| Week 5 PASI 90 |
0
0%
|
0
0%
|
0
0%
|
3.7
13.7%
|
0
0%
|
| Week 9 PASI 50 |
10.3
35.5%
|
38.5
148.1%
|
52.4
249.5%
|
85.2
315.6%
|
13.6
61.8%
|
| Week 9 PASI 75 |
3.4
11.7%
|
11.5
44.2%
|
33.3
158.6%
|
66.7
247%
|
9.1
41.4%
|
| Week 9 PASI 90 |
0
0%
|
3.8
14.6%
|
9.5
45.2%
|
14.8
54.8%
|
0
0%
|
| Week 13 PASI 50 |
17.2
59.3%
|
57.7
221.9%
|
81.0
385.7%
|
85.2
315.6%
|
18.2
82.7%
|
| Week 13 PASI 75 |
3.4
11.7%
|
19.2
73.8%
|
57.1
271.9%
|
81.5
301.9%
|
9.1
41.4%
|
| Week 13 PASI 90 |
0
0%
|
7.7
29.6%
|
19.0
90.5%
|
51.9
192.2%
|
4.5
20.5%
|
| Week 17 PASI 50 |
20.7
71.4%
|
53.8
206.9%
|
76.2
362.9%
|
85.2
315.6%
|
27.3
124.1%
|
| Week 17 PASI 75 |
6.9
23.8%
|
26.9
103.5%
|
42.9
204.3%
|
81.5
301.9%
|
13.6
61.8%
|
| Week 17 PASI 90 |
0
0%
|
15.4
59.2%
|
9.5
45.2%
|
44.4
164.4%
|
0
0%
|
| Week 21 PASI 50 |
13.8
47.6%
|
50.0
192.3%
|
57.1
271.9%
|
85.2
315.6%
|
31.8
144.5%
|
| Week 21 PASI 75 |
0
0%
|
23.1
88.8%
|
38.1
181.4%
|
77.8
288.1%
|
13.6
61.8%
|
| Week 21 PASI 90 |
0
0%
|
15.4
59.2%
|
9.5
45.2%
|
37.0
137%
|
4.5
20.5%
|
| Week 25 PASI 50 |
13.8
47.6%
|
50.0
192.3%
|
57.1
271.9%
|
85.2
315.6%
|
31.8
144.5%
|
| Week 25 PASI 75 |
0
0%
|
19.2
73.8%
|
33.3
158.6%
|
70.4
260.7%
|
9.1
41.4%
|
| Week 25 PASI 90 |
0
0%
|
11.5
44.2%
|
19.0
90.5%
|
29.6
109.6%
|
4.5
20.5%
|
| Week 29 PASI 50 |
17.2
59.3%
|
46.2
177.7%
|
52.4
249.5%
|
85.2
315.6%
|
27.3
124.1%
|
| Week 29 PASI 75 |
0
0%
|
15.4
59.2%
|
23.8
113.3%
|
59.3
219.6%
|
13.6
61.8%
|
| Week 29 PASI 90 |
0
0%
|
7.7
29.6%
|
14.3
68.1%
|
22.2
82.2%
|
9.1
41.4%
|
| Week 33 PASI 50 |
10.3
35.5%
|
34.6
133.1%
|
47.6
226.7%
|
77.8
288.1%
|
22.7
103.2%
|
| Week 33 PASI 75 |
3.4
11.7%
|
19.2
73.8%
|
23.8
113.3%
|
55.6
205.9%
|
4.5
20.5%
|
| Week 33 PASI 90 |
0
0%
|
0
0%
|
9.5
45.2%
|
18.5
68.5%
|
4.5
20.5%
|
| Week 37 PASI 50 |
17.2
59.3%
|
30.8
118.5%
|
47.6
226.7%
|
63.0
233.3%
|
22.7
103.2%
|
| Week 37 PASI 75 |
3.4
11.7%
|
19.2
73.8%
|
19.0
90.5%
|
25.9
95.9%
|
4.5
20.5%
|
| Week 37 PASI 90 |
0
0%
|
3.8
14.6%
|
9.5
45.2%
|
11.1
41.1%
|
4.5
20.5%
|
| Title | To Assess the Time to Relapse |
|---|---|
| Description | Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups. |
| Time Frame | 37 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients. |
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg |
|---|---|---|---|---|
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) |
| Measure Participants | 1 | 5 | 12 | 22 |
| Median (95% Confidence Interval) [days] |
NA
|
NA
|
NA
|
203
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | |||||
| Arm/Group Description | AIN457 25mg Subcutaneously as a single dose | AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | |||||
All Cause Mortality |
||||||||||
| AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 2/26 (7.7%) | 1/21 (4.8%) | 0/27 (0%) | 2/22 (9.1%) | |||||
| Cardiac disorders | ||||||||||
| Acute myocardial infarction | 0/29 (0%) | 0/26 (0%) | 0/21 (0%) | 0/27 (0%) | 1/22 (4.5%) | |||||
| Atrial fibrillation | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 0/27 (0%) | 0/22 (0%) | |||||
| Cardiomyopathy | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 0/27 (0%) | 0/22 (0%) | |||||
| Myocardial infarction | 0/29 (0%) | 0/26 (0%) | 0/21 (0%) | 0/27 (0%) | 1/22 (4.5%) | |||||
| Wolff-Parkinson-White syndrome | 0/29 (0%) | 0/26 (0%) | 1/21 (4.8%) | 0/27 (0%) | 0/22 (0%) | |||||
| Infections and infestations | ||||||||||
| Gastroenteritis viral | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 0/27 (0%) | 0/22 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Psoriatic arthropathy | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 0/27 (0%) | 0/22 (0%) | |||||
| Nervous system disorders | ||||||||||
| Transient ischaemic attack | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 0/27 (0%) | 0/22 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/29 (48.3%) | 11/26 (42.3%) | 10/21 (47.6%) | 16/27 (59.3%) | 8/22 (36.4%) | |||||
| General disorders | ||||||||||
| Fatigue | 0/29 (0%) | 0/26 (0%) | 0/21 (0%) | 3/27 (11.1%) | 1/22 (4.5%) | |||||
| Oedema peripheral | 0/29 (0%) | 0/26 (0%) | 0/21 (0%) | 2/27 (7.4%) | 1/22 (4.5%) | |||||
| Infections and infestations | ||||||||||
| Nasopharyngitis | 1/29 (3.4%) | 4/26 (15.4%) | 4/21 (19%) | 4/27 (14.8%) | 2/22 (9.1%) | |||||
| Pharyngitis | 0/29 (0%) | 1/26 (3.8%) | 0/21 (0%) | 2/27 (7.4%) | 0/22 (0%) | |||||
| Respiratory tract infection viral | 1/29 (3.4%) | 1/26 (3.8%) | 1/21 (4.8%) | 0/27 (0%) | 2/22 (9.1%) | |||||
| Upper respiratory tract infection | 3/29 (10.3%) | 2/26 (7.7%) | 1/21 (4.8%) | 2/27 (7.4%) | 0/22 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Muscle strain | 1/29 (3.4%) | 0/26 (0%) | 0/21 (0%) | 2/27 (7.4%) | 0/22 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 0/29 (0%) | 1/26 (3.8%) | 2/21 (9.5%) | 1/27 (3.7%) | 0/22 (0%) | |||||
| Myalgia | 2/29 (6.9%) | 0/26 (0%) | 0/21 (0%) | 0/27 (0%) | 1/22 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 1/29 (3.4%) | 2/26 (7.7%) | 1/21 (4.8%) | 1/27 (3.7%) | 0/22 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus | 1/29 (3.4%) | 0/26 (0%) | 0/21 (0%) | 1/27 (3.7%) | 3/22 (13.6%) | |||||
| Psoriasis | 8/29 (27.6%) | 4/26 (15.4%) | 4/21 (19%) | 3/27 (11.1%) | 2/22 (9.1%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 1/29 (3.4%) | 1/26 (3.8%) | 0/21 (0%) | 2/27 (7.4%) | 0/22 (0%) | |||||
Limitations/Caveats
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 or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
- CAIN457A2220
- 2009-016807-42