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AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

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ClinicalTrials.gov Identifier: NCT01132612
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 5, 2017
Last Update Posted : January 4, 2018
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 Plaque-type Psoriasis
Interventions Drug: AIN457
Drug: Placebo
Enrollment 275
Recruitment Details  
Pre-assignment Details Participants continued their regimens as assigned in CAIN457A2211 (NCT00941031) and were enrolled into one of the following: fixed time interval regimen (FI), treatment at start of relapse regimen (SR) or open-label (OL). There were no more placebo treated patients at the end of the core. Therefore, there is no placebo arm in the extension.
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Hide Arm/Group Description Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks Secukinumab 150 mg sc administered every 4 weeks.
Period Title: Overall Study
Started 46 42 187
Completed 6 7 17
Not Completed 40 35 170
Reason Not Completed
Death             0             0             1
Protocol deviation             0             0             3
Lost to Follow-up             2             2             7
Adverse Event             5             2             15
Withdrawal by Subject             5             8             19
Administrative problems             5             1             52
Lack of Efficacy             23             22             73
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label Total
Hide Arm/Group Description Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks Secukinumab 150 mg sc administered every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 46 42 187 275
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 42 participants 187 participants 275 participants
43.0  (13.71) 39.9  (12.12) 45.0  (11.78) 43.9  (12.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 42 participants 187 participants 275 participants
Female
15
  32.6%
12
  28.6%
39
  20.9%
66
  24.0%
Male
31
  67.4%
30
  71.4%
148
  79.1%
209
  76.0%
1.Primary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Hide Description Safety was assessed by frequency of adverse events including serious adverse events.
Time Frame up to week 351
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Hide Arm/Group Description:
Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Secukinumab 150 mg sc administered every 4 weeks.
Overall Number of Participants Analyzed 46 42 187
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse events
44
  95.7%
41
  97.6%
180
  96.3%
Serious adverse events
9
  19.6%
4
   9.5%
43
  23.0%
Deaths
0
   0.0%
0
   0.0%
1
   0.5%
2.Secondary Outcome
Title Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response
Hide 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). The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Time Frame Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): The FAS, which included all participants who entered the extension and to whom study drug was assigned, was considered for the analysis. Only those participants, who had evaluable data at a given time point, were analyzed at that time point.
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Hide Arm/Group Description:
Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Secukinumab 150 mg sc administered every 4 weeks.
Overall Number of Participants Analyzed 46 42 187
Measure Type: Number
Unit of Measure: Number of participants
Extension week 1, PASI 50 Number Analyzed 46 participants 40 participants 174 participants
43 34 163
Extension week 1, PASI 75 Number Analyzed 46 participants 40 participants 174 participants
31 16 102
Extension week 1, PASI 90 Number Analyzed 46 participants 40 participants 174 participants
17 3 61
Ext. week 1, IGA mod 2009 0 or 1 Number Analyzed 44 participants 38 participants 168 participants
24 7 70
Extension week 25, PASI 50 Number Analyzed 35 participants 33 participants 159 participants
29 27 142
Extension week 25, PASI 75 Number Analyzed 35 participants 33 participants 159 participants
19 10 91
Extension week 25, PASI 90 Number Analyzed 35 participants 33 participants 159 participants
12 2 42
Ext. week 25, IGA mod 2009 0 or 1 Number Analyzed 35 participants 33 participants 159 participants
15 4 48
Extension week 73, PASI 50 Number Analyzed 19 participants 19 participants 114 participants
18 17 100
Extension week 73, PASI 75 Number Analyzed 19 participants 19 participants 114 participants
14 8 66
Extension week 73, PASI 90 Number Analyzed 19 participants 19 participants 114 participants
8 1 31
Ext. week 73, IGA mod 2009 Number Analyzed 19 participants 19 participants 114 participants
9 4 35
Extension week 301, PASI 50 Number Analyzed 0 participants 0 participants 3 participants
3
Extension week 301, PASI 75 Number Analyzed 0 participants 0 participants 3 participants
2
Extension week 301, PASI 90 Number Analyzed 0 participants 0 participants 3 participants
1
Extension week 301, IGA mod 2009 Number Analyzed 0 participants 0 participants 3 participants
1
3.Secondary Outcome
Title Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial
Hide Description Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.
Time Frame up to week 351
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Hide Arm/Group Description:
Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter
Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks
Secukinumab 150 mg sc administered every 4 weeks.
Overall Number of Participants Analyzed 46 41 184
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   0.5%
Time Frame Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Hide Arm/Group Description Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks Secukinumab 150 mg sc administered every 4 weeks.
All-Cause Mortality
Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/46 (19.57%)   4/42 (9.52%)   43/187 (22.99%) 
Cardiac disorders       
Acute myocardial infarction  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Angina pectoris  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Arrhythmia  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Cardiac arrest  1  0/46 (0.00%)  0/42 (0.00%)  2/187 (1.07%) 
Coronary artery disease  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Coronary artery stenosis  1  0/46 (0.00%)  1/42 (2.38%)  0/187 (0.00%) 
Ventricular fibrillation  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Ventricular tachycardia  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Ear and labyrinth disorders       
Tinnitus  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Eye disorders       
Cataract  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Gastrointestinal disorders       
Crohn's disease  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Haemorrhoids  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Inguinal hernia  1  0/46 (0.00%)  1/42 (2.38%)  1/187 (0.53%) 
Intestinal ischaemia  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Intussusception  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Nausea  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
General disorders       
Chest discomfort  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Non-cardiac chest pain  1  0/46 (0.00%)  1/42 (2.38%)  1/187 (0.53%) 
Hepatobiliary disorders       
Hepatic cirrhosis  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Infections and infestations       
Abscess bacterial  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Anal abscess  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Campylobacter gastroenteritis  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Cellulitis  1  0/46 (0.00%)  1/42 (2.38%)  4/187 (2.14%) 
Diverticulitis  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Enterocolitis infectious  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Impetigo  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Infected dermal cyst  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Nail infection  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Osteomyelitis  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Osteomyelitis chronic  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Paronychia  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Staphylococcal abscess  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Staphylococcal infection  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Streptococcal infection  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Urinary tract infection  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Injury, poisoning and procedural complications       
Laceration  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Meniscus injury  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Muscle injury  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Road traffic accident  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Tendon injury  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Upper limb fracture  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Investigations       
Fibrin D dimer increased  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Streptococcus test positive  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Metabolism and nutrition disorders       
Dehydration  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Diabetes mellitus  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Diabetic ketoacidosis  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Hyperkalaemia  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Intervertebral disc disorder  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Intervertebral disc protrusion  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Osteoarthritis  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Tenosynovitis  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/46 (0.00%)  0/42 (0.00%)  2/187 (1.07%) 
Colon adenoma  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Colon cancer  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Malignant melanoma  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Pleomorphic adenoma  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Superficial spreading melanoma stage unspecified  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Nervous system disorders       
Dizziness  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Facial paralysis  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Hemiparesis  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Hepatic encephalopathy  1  1/46 (2.17%)  0/42 (0.00%)  0/187 (0.00%) 
Migraine  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Syncope  1  1/46 (2.17%)  0/42 (0.00%)  1/187 (0.53%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Psychiatric disorders       
Anxiety  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Depression  1  0/46 (0.00%)  0/42 (0.00%)  2/187 (1.07%) 
Renal and urinary disorders       
Acute kidney injury  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Bladder stenosis  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
End stage renal disease  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Haematuria  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Asthma  1  1/46 (2.17%)  0/42 (0.00%)  1/187 (0.53%) 
Sleep apnoea syndrome  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic  1  0/46 (0.00%)  0/42 (0.00%)  1/187 (0.53%) 
Psoriasis  1  0/46 (0.00%)  0/42 (0.00%)  2/187 (1.07%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fixed-time Interval Regimen Treatment at Start of Relapse Regimen Open-label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/46 (91.30%)   35/42 (83.33%)   164/187 (87.70%) 
Gastrointestinal disorders       
Abdominal pain upper  1  2/46 (4.35%)  0/42 (0.00%)  11/187 (5.88%) 
Dental caries  1  3/46 (6.52%)  1/42 (2.38%)  6/187 (3.21%) 
Diarrhoea  1  2/46 (4.35%)  2/42 (4.76%)  20/187 (10.70%) 
Nausea  1  3/46 (6.52%)  3/42 (7.14%)  12/187 (6.42%) 
Toothache  1  4/46 (8.70%)  1/42 (2.38%)  14/187 (7.49%) 
Vomiting  1  1/46 (2.17%)  3/42 (7.14%)  13/187 (6.95%) 
General disorders       
Fatigue  1  2/46 (4.35%)  3/42 (7.14%)  12/187 (6.42%) 
Influenza like illness  1  1/46 (2.17%)  2/42 (4.76%)  12/187 (6.42%) 
Pyrexia  1  1/46 (2.17%)  4/42 (9.52%)  9/187 (4.81%) 
Infections and infestations       
Bronchitis  1  2/46 (4.35%)  1/42 (2.38%)  21/187 (11.23%) 
Conjunctivitis  1  4/46 (8.70%)  0/42 (0.00%)  4/187 (2.14%) 
Gastroenteritis viral  1  1/46 (2.17%)  4/42 (9.52%)  9/187 (4.81%) 
Influenza  1  4/46 (8.70%)  2/42 (4.76%)  14/187 (7.49%) 
Nasopharyngitis  1  20/46 (43.48%)  16/42 (38.10%)  91/187 (48.66%) 
Oral herpes  1  1/46 (2.17%)  1/42 (2.38%)  10/187 (5.35%) 
Pharyngitis streptococcal  1  3/46 (6.52%)  2/42 (4.76%)  4/187 (2.14%) 
Sinusitis  1  9/46 (19.57%)  3/42 (7.14%)  17/187 (9.09%) 
Tonsillitis  1  1/46 (2.17%)  0/42 (0.00%)  14/187 (7.49%) 
Upper respiratory tract infection  1  3/46 (6.52%)  4/42 (9.52%)  28/187 (14.97%) 
Urinary tract infection  1  3/46 (6.52%)  4/42 (9.52%)  6/187 (3.21%) 
Injury, poisoning and procedural complications       
Contusion  1  2/46 (4.35%)  2/42 (4.76%)  10/187 (5.35%) 
Ligament sprain  1  1/46 (2.17%)  2/42 (4.76%)  10/187 (5.35%) 
Procedural pain  1  4/46 (8.70%)  0/42 (0.00%)  6/187 (3.21%) 
Investigations       
Alanine aminotransferase increased  1  1/46 (2.17%)  0/42 (0.00%)  12/187 (6.42%) 
C-reactive protein increased  1  3/46 (6.52%)  0/42 (0.00%)  6/187 (3.21%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  1/46 (2.17%)  3/42 (7.14%)  14/187 (7.49%) 
Hypertriglyceridaemia  1  0/46 (0.00%)  1/42 (2.38%)  10/187 (5.35%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  9/46 (19.57%)  6/42 (14.29%)  43/187 (22.99%) 
Arthritis  1  3/46 (6.52%)  1/42 (2.38%)  6/187 (3.21%) 
Back pain  1  5/46 (10.87%)  7/42 (16.67%)  30/187 (16.04%) 
Musculoskeletal pain  1  5/46 (10.87%)  0/42 (0.00%)  15/187 (8.02%) 
Myalgia  1  2/46 (4.35%)  3/42 (7.14%)  8/187 (4.28%) 
Neck pain  1  3/46 (6.52%)  1/42 (2.38%)  6/187 (3.21%) 
Pain in extremity  1  4/46 (8.70%)  1/42 (2.38%)  11/187 (5.88%) 
Nervous system disorders       
Dizziness  1  3/46 (6.52%)  0/42 (0.00%)  4/187 (2.14%) 
Headache  1  11/46 (23.91%)  6/42 (14.29%)  29/187 (15.51%) 
Psychiatric disorders       
Anxiety  1  0/46 (0.00%)  0/42 (0.00%)  11/187 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/46 (4.35%)  4/42 (9.52%)  20/187 (10.70%) 
Oropharyngeal pain  1  5/46 (10.87%)  3/42 (7.14%)  14/187 (7.49%) 
Skin and subcutaneous tissue disorders       
Eczema  1  4/46 (8.70%)  0/42 (0.00%)  6/187 (3.21%) 
Psoriasis  1  13/46 (28.26%)  16/42 (38.10%)  59/187 (31.55%) 
Vascular disorders       
Hypertension  1  4/46 (8.70%)  6/42 (14.29%)  26/187 (13.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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 (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
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01132612     History of Changes
Other Study ID Numbers: CAIN457A2211E1
2009-017234-51 ( EudraCT Number )
First Submitted: May 19, 2010
First Posted: May 28, 2010
Results First Submitted: October 17, 2017
Results First Posted: December 5, 2017
Last Update Posted: January 4, 2018