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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT00941031
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : March 27, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Plaque-type Psoriasis
Interventions Drug: AIN457
Drug: AIN457A
Drug: Placebo
Enrollment 404
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Placebo Dose Fixed Interval Start of Relapse Open Label
Hide Arm/Group Description Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12 Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12 Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12 Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12 Fixed-time interval regimen - "FI": secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29 Treatment at start of relapse regimen - "SR": Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29 Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
Period Title: Induction Period
Started 66 138 133 67 0 0 0
Completed 61 134 127 58 0 0 0
Not Completed 5 4 6 9 0 0 0
Reason Not Completed
Lack of Efficacy             2             1             0             5             0             0             0
Withdrawal by Subject             1             2             2             2             0             0             0
Adminstative Problems             1             1             1             0             0             0             0
Adverse Event             1             0             3             2             0             0             0
Period Title: Maintenance Period
Started 0 [1] 0 [1] 0 [1] 0 [2] 65 [1] 67 [1] 247 [2]
Completed 0 [1] 0 [1] 0 [1] 0 [2] 56 61 204
Not Completed 0 0 0 0 9 6 43
Reason Not Completed
Withdrawal by Subject             0             0             0             0             6             2             13
Administrative Problems             0             0             0             0             1             0             1
Protocol Violation             0             0             0             0             0             0             1
Adverse Event             0             0             0             0             0             2             8
Lost to Follow-up             0             0             0             0             2             2             7
Lack of Efficacy             0             0             0             0             0             0             13
[1]
Responders at week 13 were re randomized to one of the maintenance treatment arms in a ratio of 1:1
[2]
Non Responders treated with an open label regimen.
Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Dose Placebo Total
Hide Arm/Group Description Baseline through Week 12 [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 66 138 133 67 404
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 138 participants 133 participants 67 participants 404 participants
42.7  (11.32) 44.2  (12.96) 44.5  (12.45) 44.2  (12.59) 44.1  (12.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 138 participants 133 participants 67 participants 404 participants
Female
13
  19.7%
34
  24.6%
28
  21.1%
23
  34.3%
98
  24.3%
Male
53
  80.3%
104
  75.4%
105
  78.9%
44
  65.7%
306
  75.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 138 participants 133 participants 67 participants 404 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
  10.6%
17
  12.3%
14
  10.5%
8
  11.9%
46
  11.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
1
   0.2%
Black or African American
0
   0.0%
1
   0.7%
0
   0.0%
1
   1.5%
2
   0.5%
White
59
  89.4%
120
  87.0%
118
  88.7%
56
  83.6%
353
  87.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.8%
1
   1.5%
2
   0.5%
1.Primary Outcome
Title The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.
Hide Description Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Dose Placebo Dose
Hide Arm/Group Description:
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Overall Number of Participants Analyzed 66 138 132 66
Measure Type: Number
Unit of Measure: Participants achieving goal
PASI 50 18 83 101 7
PASI 75 7 58 72 1
PASI 90 2 24 42 1
2.Secondary Outcome
Title The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29
Hide Description [Not Specified]
Time Frame week 21 to 29
Hide Outcome Measure Data
Hide Analysis Population Description
(Full analysis set, LOCF)
Arm/Group Title Maintenance Fixed Interval Maintenance Start of Relapse Maintenance Open Label
Hide Arm/Group Description:
Fixed-time interval regimen - "FI": secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
Treatment at start of relapse regimen - "SR": Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
Overall Number of Participants Analyzed 65 67 247
Measure Type: Number
Unit of Measure: Participants achieving goal
PASI 50 64 60 200
PASI 75 55 45 114
PASI 90 38 14 53
3.Secondary Outcome
Title The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo
Hide Description The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Dose Placebo Dose
Hide Arm/Group Description:
Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Overall Number of Participants Analyzed 66 137 132 66
Measure Type: Number
Unit of Measure: Participants achieving goal
0=clear 0 2 17 1
1= almost clear 3 29 32 0
2= mild disease 17 42 38 3
3= moderate disease 28 44 33 26
4=severe disease 15 18 12 29
5= very serious disease 3 2 0 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INDUCTION: Single INDUCTION: Monthly INDUCTION: Early INDUCTION: Placebo MAINTENANCE: Fixed Interval MAINTENANCE: Start of Relapse MAINTENANCE: Open Label FOLLOW-UP: Fixed Interval FOLLOW-UP: Start of Relapse FOLLOW-UP: Open Label
Hide Arm/Group Description INDUCTION: Early loading induction - 'Early' INDUCTION: with monthly injections - 'Monthly' INDUCTION: with single injection - 'Single' INDUCTION: Placebo - 'Placebo' MAINTENANCE: Fixed-time interval regimen - 'FI' MAINTENANCE: Treatment at start of relapse regimen - 'SR' MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - "OL": secukinumab (AIN457) 150 mg s.c. administered every 4 weeks. FOLLOW-UP: Fixed-time interval regimen - 'FI' FOLLOW-UP: Treatment at start of relapse regimen - 'SR' FOLLOW-UP: Open label
All-Cause Mortality
INDUCTION: Single INDUCTION: Monthly INDUCTION: Early INDUCTION: Placebo MAINTENANCE: Fixed Interval MAINTENANCE: Start of Relapse MAINTENANCE: Open Label FOLLOW-UP: Fixed Interval FOLLOW-UP: Start of Relapse FOLLOW-UP: Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
INDUCTION: Single INDUCTION: Monthly INDUCTION: Early INDUCTION: Placebo MAINTENANCE: Fixed Interval MAINTENANCE: Start of Relapse MAINTENANCE: Open Label FOLLOW-UP: Fixed Interval FOLLOW-UP: Start of Relapse FOLLOW-UP: Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/66 (4.55%)   3/138 (2.17%)   6/133 (4.51%)   1/67 (1.49%)   4/65 (6.15%)   2/67 (2.99%)   12/247 (4.86%)   0/17 (0.00%)   0/15 (0.00%)   5/72 (6.94%) 
Cardiac disorders                     
Angina pectoris  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Arrhythmia  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Coronary artery disease  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Ventricular fibrillation  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Eye disorders                     
Cataract  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Gastrointestinal disorders                     
Abdominal pain  1  0/66 (0.00%)  1/138 (0.72%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Colonic stenosis  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/67 (1.49%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Hepatobiliary disorders                     
Hepatic cirrhosis  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Infections and infestations                     
Acute tonsillitis  1  1/66 (1.52%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Anal abscess  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Appendicitis  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Enterocolitis infectious  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/67 (1.49%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Pneumonia bacterial  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Septic shock  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Staphylococcal infection  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Injury, poisoning and procedural complications                     
Injury  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Muscle injury  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Road traffic accident  1  0/66 (0.00%)  1/138 (0.72%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Upper limb fracture  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Back pain  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Intervertebral disc disorder  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Rhabdomyolysis  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Bladder cancer  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Colon adenoma  1  1/66 (1.52%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Colon cancer  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Lung neoplasm malignant  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Malignant melanoma in situ  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Testis cancer  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Renal and urinary disorders                     
Nephrolithiasis  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Acute respiratory failure  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders                     
Erythrodermic psoriasis  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Psoriasis  1  0/66 (0.00%)  1/138 (0.72%)  0/133 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/67 (0.00%)  1/247 (0.40%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Vascular disorders                     
Hypertensive crisis  1  1/66 (1.52%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
INDUCTION: Single INDUCTION: Monthly INDUCTION: Early INDUCTION: Placebo MAINTENANCE: Fixed Interval MAINTENANCE: Start of Relapse MAINTENANCE: Open Label FOLLOW-UP: Fixed Interval FOLLOW-UP: Start of Relapse FOLLOW-UP: Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/66 (34.85%)   53/138 (38.41%)   46/133 (34.59%)   29/67 (43.28%)   16/65 (24.62%)   16/67 (23.88%)   83/247 (33.60%)   3/17 (17.65%)   4/15 (26.67%)   5/72 (6.94%) 
General disorders                     
Inflammation  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  1/15 (6.67%)  0/72 (0.00%) 
Infections and infestations                     
Nasopharyngitis  1  8/66 (12.12%)  31/138 (22.46%)  30/133 (22.56%)  12/67 (17.91%)  6/65 (9.23%)  5/67 (7.46%)  35/247 (14.17%)  0/17 (0.00%)  0/15 (0.00%)  2/72 (2.78%) 
Upper respiratory tract infection  1  3/66 (4.55%)  6/138 (4.35%)  2/133 (1.50%)  6/67 (8.96%)  2/65 (3.08%)  0/67 (0.00%)  17/247 (6.88%)  0/17 (0.00%)  1/15 (6.67%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  2/66 (3.03%)  8/138 (5.80%)  0/133 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  1/67 (1.49%)  9/247 (3.64%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Flank pain  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  1/15 (6.67%)  0/72 (0.00%) 
Nervous system disorders                     
Headache  1  6/66 (9.09%)  8/138 (5.80%)  11/133 (8.27%)  3/67 (4.48%)  3/65 (4.62%)  1/67 (1.49%)  13/247 (5.26%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Migraine with aura  1  0/66 (0.00%)  0/138 (0.00%)  0/133 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  0/67 (0.00%)  0/247 (0.00%)  0/17 (0.00%)  1/15 (6.67%)  0/72 (0.00%) 
Sinus headache  1  0/66 (0.00%)  0/138 (0.00%)  1/133 (0.75%)  0/67 (0.00%)  0/65 (0.00%)  1/67 (1.49%)  0/247 (0.00%)  1/17 (5.88%)  0/15 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough  1  1/66 (1.52%)  2/138 (1.45%)  4/133 (3.01%)  4/67 (5.97%)  0/65 (0.00%)  0/67 (0.00%)  8/247 (3.24%)  0/17 (0.00%)  0/15 (0.00%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders                     
Psoriasis  1  6/66 (9.09%)  7/138 (5.07%)  4/133 (3.01%)  6/67 (8.96%)  4/65 (6.15%)  6/67 (8.96%)  16/247 (6.48%)  2/17 (11.76%)  1/15 (6.67%)  1/72 (1.39%) 
Vascular disorders                     
Hypertension  1  3/66 (4.55%)  1/138 (0.72%)  2/133 (1.50%)  1/67 (1.49%)  2/65 (3.08%)  5/67 (7.46%)  5/247 (2.02%)  0/17 (0.00%)  0/15 (0.00%)  1/72 (1.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00941031    
Other Study ID Numbers: CAIN457A2211
2008-007525-39 ( EudraCT Number )
First Submitted: July 16, 2009
First Posted: July 17, 2009
Results First Submitted: January 30, 2015
Results First Posted: March 27, 2015
Last Update Posted: August 20, 2015