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AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00941031
Collaborator
(none)
404
Enrollment
62
Locations
4
Arms
17
Duration (Months)
6.5
Patients Per Site
0.4
Patients Per Site Per Month

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

Study Type:
Interventional
Actual Enrollment :
404 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Induction Single Dose

Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12

Drug: AIN457
Other Names:
  • Secukinumab

    		•
    Experimental: Induction Monthly Dose

    Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12

    Drug: AIN457A
    Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9
    Other Names:
  • Secukinumab

    		•
    Experimental: Induction Early Loading Dose

    Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12

    Drug: AIN457A
    Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5
    Other Names:
  • Secukinumab

    		•
    Placebo Comparator: Placebo Dose

    Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12

    Drug: Placebo
    Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

    Outcome Measures

    Primary Outcome Measures

    1. 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. [13 weeks]

      Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment

    Secondary Outcome Measures

    1. The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29 [week 21 to 29]

    2. 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 [13 weeks]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men or women at least 18 years of age at time of consent

    • Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

    • At time of 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 and/or

    • phototherapy and/or

    • previous systemic therapy

    Exclusion Criteria:

    • Patients meeting any of the following criteria will be excluded from entry into the study:

    • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization

    • Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization

    • Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to

    • Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration

    • Known immunosuppression (e.g., AIDS) at screening and / or randomization

    • History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.

    • Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis)

    • At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases

    • History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization

    • History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization

    • Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study

    • Pregnant or nursing (lactating) women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Birmingham Alabama United States 35233
    2 Novartis Investigative Site Little Rock Arkansas United States 72205
    3 Novartis Investigative Site Pasadena California United States 91105
    4 Novartis Investigative Site San Diego California United States 92123
    5 Novartis Investigative Site Newnan Georgia United States 30263
    6 Novartis Investigative Site Snellville Georgia United States 30078
    7 Novartis Investigative Site Champaign Illinois United States 61820
    8 Novartis Investigative Site Springfield Illinois United States 62703
    9 Novartis Investigative Site Evansville Indiana United States 47713
    10 Novartis Investigative Site Topeka Kansas United States 66606
    11 Novartis Investigative Site Louisville Kentucky United States 40217
    12 Novartis Investigative Site Boston Massachusetts United States 02111
    13 Novartis Investigative Site Clinton Twp. Michigan United States 48038
    14 Novartis Investigative Site Detroit Michigan United States 48202
    15 Novartis Investigative Site Minneapolis Minnesota United States 55455
    16 Novartis Investigative Site St. Louis Missouri United States 63117
    17 Novartis Investigative Site Omaha Nebraska United States 68131
    18 Novartis Investigative Site Omaha Nebraska United States 68144
    19 Novartis Investigative Site Henderson Nevada United States 89052
    20 Novartis Investigative Site New York New York United States 10029
    21 Novartis Investigative Site Rochester New York United States 14623
    22 Novartis Investigative Site High Point North Carolina United States 27262
    23 Novartis Investigative Site Lake Oswego Oregon United States 97035
    24 Novartis Investigative Site Portland Oregon United States 97210
    25 Novartis Investigative Site Philadelphia Pennsylvania United States 19104
    26 Novartis Investigative Site Austin Texas United States 78759
    27 Novartis Investigative Site Dallas Texas United States 75204
    28 Novartis Investigative Site Charlottesville Virginia United States 22911
    29 Novartis Investigative Site Lynchburg Virginia United States 24501
    30 Novartis Investigative Site Nice France 06202
    31 Novartis Investigative Site Toulouse Cedex France 31059
    32 Novartis Investigative Site Berlin Germany 10117
    33 Novartis Investigative Site Bonn Germany 53105
    34 Novartis Investigative Site Dresden Germany 01307
    35 Novartis Investigative Site Erlangen Germany 91054
    36 Novartis Investigative Site Frankfurt Germany 60590
    37 Novartis Investigative Site Göttingen Germany 37075
    38 Novartis Investigative Site Hamburg Germany 20354
    39 Novartis Investigative Site Hannover Germany 30625
    40 Novartis Investigative Site Kiel Germany 24105
    41 Novartis Investigative Site Leipzig Germany 04103
    42 Novartis Investigative Site Luebeck Germany 23538
    43 Novartis Investigative Site Mainz Germany 55131
    44 Novartis Investigative Site Muenster Germany 48149
    45 Novartis Investigative Site Tuebingen Germany 72076
    46 Novartis Investigative Site Kopavogur Iceland 201
    47 Novartis Investigative Site Afula Israel 18101
    48 Novartis Investigative Site Petach Tikva Israel 49100
    49 Novartis Investigative Site Ramat Gan Israel 52621
    50 Novartis Investigative Site Nagoya-city Aichi Japan 467-8602
    51 Novartis Investigative Site Fukuoka-city Fukuoka Japan 814-0180
    52 Novartis Investigative Site Kitakyushu Fukuoka Japan 807-8556
    53 Novartis Investigative Site Kurume Fukuoka Japan 830-0011
    54 Novartis Investigative Site Maebashi-city Gunma Japan 371-8511
    55 Novartis Investigative Site Chitose Hokkaido Japan 066-0021
    56 Novartis Investigative Site Bunkyo-ku Tokyo Japan 113-8655
    57 Novartis Investigative Site Itabashi-ku Tokyo Japan 173-8610
    58 Novartis Investigative Site Minato-ku Tokyo Japan 105-8471
    59 Novartis Investigative Site Shinagawa-ku Tokyo Japan 141-8625
    60 Novartis Investigative Site Bergen Norway NO-5021
    61 Novartis Investigative Site Oslo Norway 0424
    62 Novartis Investigative Site Ålesund Norway 6017

    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:
    NCT00941031
    Other Study ID Numbers:
    • CAIN457A2211
    • 2008-007525-39
    First Posted:
    Jul 17, 2009
    Last Update Posted:
    Aug 20, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Novartis Pharmaceuticals
    Moderate to severe chronic plaque-type psoriasis
    AIN457
    dermatology
    Additional relevant MeSH terms:
    Psoriasis
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Placebo Dose Fixed Interval Start of Relapse Open Label
    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
    Period Title: Induction Period
    STARTED 0 0 0 0 65 67 247
    COMPLETED 0 0 0 0 56 61 204
    NOT COMPLETED 0 0 0 0 9 6 43

    Baseline Characteristics

    Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Dose Placebo Total
    Arm/Group Description Baseline through Week 12 Total of all reporting groups
    Overall Participants 66 138 133 67 404
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    42.7
    (11.32)
    44.2
    (12.96)
    44.5
    (12.45)
    44.2
    (12.59)
    44.1
    (12.44)
    Sex: Female, Male (Count of 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) (Count of Participants)
    American Indian or Alaska Native
    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%
    1
    1.5%
    1
    0.2%
    Black or African American
    0
    0%
    1
    0.7%
    0
    0%
    1
    1.5%
    2
    0.5%
    White
    59
    89.4%
    120
    87%
    118
    88.7%
    56
    83.6%
    353
    87.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    1
    0.8%
    1
    1.5%
    2
    0.5%

    Outcome Measures

    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.
    Description Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment
    Time Frame 13 weeks

    Outcome Measure Data

    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
    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
    Measure Participants 66 138 132 66
    PASI 50
    18
    27.3%
    83
    60.1%
    101
    75.9%
    7
    10.4%
    PASI 75
    7
    10.6%
    58
    42%
    72
    54.1%
    1
    1.5%
    PASI 90
    2
    3%
    24
    17.4%
    42
    31.6%
    1
    1.5%
    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
    Description
    Time Frame week 21 to 29

    Outcome Measure Data

    Analysis Population Description
    (Full analysis set, LOCF)
    Arm/Group Title Maintenance Fixed Interval Maintenance Start of Relapse Maintenance Open Label
    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
    Measure Participants 65 67 247
    PASI 50
    64
    97%
    60
    43.5%
    200
    150.4%
    PASI 75
    55
    83.3%
    45
    32.6%
    114
    85.7%
    PASI 90
    38
    57.6%
    14
    10.1%
    53
    39.8%
    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
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set
    Arm/Group Title Induction Single Dose Induction Monthly Dose Induction Early Loading Dose Placebo Dose
    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
    Measure Participants 66 137 132 66
    0=clear
    0
    0%
    2
    1.4%
    17
    12.8%
    1
    1.5%
    1= almost clear
    3
    4.5%
    29
    21%
    32
    24.1%
    0
    0%
    2= mild disease
    17
    25.8%
    42
    30.4%
    38
    28.6%
    3
    4.5%
    3= moderate disease
    28
    42.4%
    44
    31.9%
    33
    24.8%
    26
    38.8%
    4=severe disease
    15
    22.7%
    18
    13%
    12
    9%
    29
    43.3%
    5= very serious disease
    3
    4.5%
    2
    1.4%
    0
    0%
    7
    10.4%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    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
    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 (%) # 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 / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    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 (%) # 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 3/66 (4.5%) 3/138 (2.2%) 6/133 (4.5%) 1/67 (1.5%) 4/65 (6.2%) 2/67 (3%) 12/247 (4.9%) 0/17 (0%) 0/15 (0%) 5/72 (6.9%)
    Cardiac disorders
    Angina pectoris 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Arrhythmia 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Coronary artery disease 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Ventricular fibrillation 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Eye disorders
    Cataract 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/66 (0%) 1/138 (0.7%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Colonic stenosis 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Lower gastrointestinal haemorrhage 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 1/67 (1.5%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Hepatobiliary disorders
    Hepatic cirrhosis 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Infections and infestations
    Acute tonsillitis 1/66 (1.5%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Anal abscess 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Appendicitis 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Enterocolitis infectious 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 1/67 (1.5%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Pneumonia bacterial 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Septic shock 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Staphylococcal infection 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Injury, poisoning and procedural complications
    Injury 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Muscle injury 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Road traffic accident 0/66 (0%) 1/138 (0.7%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Upper limb fracture 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Intervertebral disc disorder 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Rhabdomyolysis 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Colon adenoma 1/66 (1.5%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Colon cancer 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Lung neoplasm malignant 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Malignant melanoma in situ 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Testis cancer 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Renal and urinary disorders
    Nephrolithiasis 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Psoriasis 0/66 (0%) 1/138 (0.7%) 0/133 (0%) 1/67 (1.5%) 0/65 (0%) 0/67 (0%) 1/247 (0.4%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)
    Vascular disorders
    Hypertensive crisis 1/66 (1.5%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Other (Not Including 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 (%) # 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 23/66 (34.8%) 53/138 (38.4%) 46/133 (34.6%) 29/67 (43.3%) 16/65 (24.6%) 16/67 (23.9%) 83/247 (33.6%) 3/17 (17.6%) 4/15 (26.7%) 5/72 (6.9%)
    General disorders
    Inflammation 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 1/15 (6.7%) 0/72 (0%)
    Infections and infestations
    Nasopharyngitis 8/66 (12.1%) 31/138 (22.5%) 30/133 (22.6%) 12/67 (17.9%) 6/65 (9.2%) 5/67 (7.5%) 35/247 (14.2%) 0/17 (0%) 0/15 (0%) 2/72 (2.8%)
    Upper respiratory tract infection 3/66 (4.5%) 6/138 (4.3%) 2/133 (1.5%) 6/67 (9%) 2/65 (3.1%) 0/67 (0%) 17/247 (6.9%) 0/17 (0%) 1/15 (6.7%) 1/72 (1.4%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/66 (3%) 8/138 (5.8%) 0/133 (0%) 0/67 (0%) 1/65 (1.5%) 1/67 (1.5%) 9/247 (3.6%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Flank pain 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 1/15 (6.7%) 0/72 (0%)
    Nervous system disorders
    Headache 6/66 (9.1%) 8/138 (5.8%) 11/133 (8.3%) 3/67 (4.5%) 3/65 (4.6%) 1/67 (1.5%) 13/247 (5.3%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Migraine with aura 0/66 (0%) 0/138 (0%) 0/133 (0%) 0/67 (0%) 0/65 (0%) 0/67 (0%) 0/247 (0%) 0/17 (0%) 1/15 (6.7%) 0/72 (0%)
    Sinus headache 0/66 (0%) 0/138 (0%) 1/133 (0.8%) 0/67 (0%) 0/65 (0%) 1/67 (1.5%) 0/247 (0%) 1/17 (5.9%) 0/15 (0%) 0/72 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/66 (1.5%) 2/138 (1.4%) 4/133 (3%) 4/67 (6%) 0/65 (0%) 0/67 (0%) 8/247 (3.2%) 0/17 (0%) 0/15 (0%) 0/72 (0%)
    Skin and subcutaneous tissue disorders
    Psoriasis 6/66 (9.1%) 7/138 (5.1%) 4/133 (3%) 6/67 (9%) 4/65 (6.2%) 6/67 (9%) 16/247 (6.5%) 2/17 (11.8%) 1/15 (6.7%) 1/72 (1.4%)
    Vascular disorders
    Hypertension 3/66 (4.5%) 1/138 (0.7%) 2/133 (1.5%) 1/67 (1.5%) 2/65 (3.1%) 5/67 (7.5%) 5/247 (2%) 0/17 (0%) 0/15 (0%) 1/72 (1.4%)

    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 (ie, data from all sites) in the clinical trial

    Results Point of Contact

    Name/Title Study Director
    Organization Novartis Pharmaceuticals
    Phone 862-778-8300
    Email
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00941031
    Other Study ID Numbers:
    • CAIN457A2211
    • 2008-007525-39
    First Posted:
    Jul 17, 2009
    Last Update Posted:
    Aug 20, 2015
    Last Verified:
    Mar 1, 2015