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Safety and Efficacy of AIN457 in Noninfectious Uveitis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00685399
Collaborator
(none)
76
Enrollment
23
Locations
8
Arms
63
Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Participants were administered with AIN457 (Sp2/0derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.

Drug: AIN457
AIN457 subcutaneous dose
Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 2

    Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.

    Drug: AIN457
    AIN457 subcutaneous dose
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 3

    Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.

    Drug: AIN 457
    AIN457 low dose (i.v)
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 4

    Extension period: Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.

    Drug: AIN 457
    AIN457 low dose (i.v)
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 5

    Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.

    Drug: AIN457
    AIN457 high dose (i.v)
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 6 Arm 1

    Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).

    Drug: AIN457
    AIN457 high dose (i.v)
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 6 Arm 2

    Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).

    Drug: AIN 457
    AIN457 low dose (i.v)
    Other Names:
  • Secukinumab

    		•
    Experimental: Cohort 6 Arm 3

    Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.

    Drug: AIN457
    AIN457 high dose (i.v)
    Other Names:
  • Secukinumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died [Day 1 to Day 603]

      AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

    Secondary Outcome Measures

    1. Number of Responders in Cohort 1, 2, 3 and 6 at Day 57 [Day 1 (Baseline), Day 57]

      A "responder" was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks.

    2. Number of Complete Responders in Cohort 2, 3 and 6 at Day 57 [Day 1 (Baseline), Day 57]

      A "complete responder" was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given).

    3. Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs [Baseline (Day 1) up to Month 8]

      Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician's judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.

    4. Number of Participants Who Were Able to Induce a Remission in Uveitis [Day 1 to Day 85]

      Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.

    5. Number of Participants With Remission in Uveitis [Baseline (Day 1) up to Month 8]

      Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.

    6. Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs [Day 1 to Day 57]

      A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades "0" (zero), "trace" (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Active uveitis (i.e., uveitis that is not in remission).

    • Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.

    Exclusion criteria:

    • Active infection.

    • Weight must not be greater that 120kg.

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Beverly Hills California United States 90211
    2 Novartis Investigative Site Los Angeles California United States 90033
    3 Novartis Investigative Site Sacramento California United States 95819
    4 Novartis Investigative Site Denver Colorado United States 80210
    5 Novartis Investigative Site Golden Colorado United States 80401
    6 Novartis Investigative Site Littleton Colorado United States 80120
    7 Novartis Investigative Site Atlanta Georgia United States 30322
    8 Novartis Investigative Site Baltimore Maryland United States 21201
    9 Novartis Investigative Site Baltimore Maryland United States 21287
    10 Novartis Investigative Site Cambridge Massachusetts United States 02142
    11 Novartis Investigative Site Kansas City Missouri United States 64111
    12 Novartis Investigative Site Teaneck New Jersey United States 07666
    13 Novartis Investigative Site New York New York United States 10022
    14 Novartis Investigative Site Slingerlands New York United States 12159
    15 Novartis Investigative Site Durham North Carolina United States 27710
    16 Novartis Investigative Site Cleveland Ohio United States 44195
    17 Novartis Investigative Site Spartanburg South Carolina United States 29306
    18 Novartis Investigative Site Arlington Texas United States 76012
    19 Novartis Investigative Site Austin Texas United States 78793
    20 Novartis Investigative Site Houston Texas United States 77030
    21 Novartis Investigative Site Berlin Germany 13353
    22 Novartis Investigative Site Heidelberg Germany 691120
    23 Novartis Investigative Site Tübingen Germany 72076

    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:
    NCT00685399
    Other Study ID Numbers:
    • CAIN457A2208
    • 2011-001243-67
    First Posted:
    May 28, 2008
    Last Update Posted:
    Jul 17, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Novartis Pharmaceuticals
    Uveitis
    eye
    IL-17
    IL-17A
    IL17
    AIN457
    Vogt-Koyanagi-Harada
    Behcet's
    Behcet
    Sympathetic ophthalmia
    Multifocal choroiditis
    Birdshot
    HLA-B27
    Birdshot retinochoroiditis
    Retinal vasculitis
    Sarcoidosis
    Intermediate uveitis
    Panuveitis
    Posterior uveitis
    Additional relevant MeSH terms:
    Uveitis
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    Recruitment Details This is a multi-center study which comprised of 6 cohorts. This study was a proof of concept study.
    Pre-assignment Detail
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Arm 1 Cohort 6 Arm 2 Cohort 6 Arm 3
    Arm/Group Description Participants were administered with AIN457 (Sp2/0-derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22. Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants who experienced a remission of their uveitis within 8 weeks after receiving their final dose of AIN457 while enrolled in Cohorts 1, 2, 3, 5 or 6 were administered with AIN457 10 mg/kg, i.v. infusion (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator. Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all. Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
    Period Title: Treatment Period 1
    STARTED 16 0 0 0 0 0 0 0
    COMPLETED 10 0 0 0 0 0 0 0
    NOT COMPLETED 6 0 0 0 0 0 0 0
    Period Title: Treatment Period 1
    STARTED 0 14 5 0 4 12 13 12
    COMPLETED 0 2 2 0 4 10 13 10
    NOT COMPLETED 0 12 3 0 0 2 0 2
    Period Title: Treatment Period 1
    STARTED 0 0 0 28 0 0 0 0
    COMPLETED 0 0 0 21 0 0 0 0
    NOT COMPLETED 0 0 0 7 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 5 Cohort 6 Arm 1 Cohort 6 Arm 2 Cohort 6 Arm 3 Total
    Arm/Group Description Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all. Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups. Total of all reporting groups
    Overall Participants 16 14 5 4 12 13 12 76
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    7.7%
    0
    0%
    1
    1.3%
    Between 18 and 65 years
    15
    93.8%
    13
    92.9%
    5
    100%
    4
    100%
    12
    100%
    11
    84.6%
    12
    100%
    72
    94.7%
    >=65 years
    1
    6.3%
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    1
    7.7%
    0
    0%
    3
    3.9%
    Sex: Female, Male (Count of Participants)
    Female
    12
    75%
    10
    71.4%
    3
    60%
    3
    75%
    8
    66.7%
    9
    69.2%
    9
    75%
    54
    71.1%
    Male
    4
    25%
    4
    28.6%
    2
    40%
    1
    25%
    4
    33.3%
    4
    30.8%
    3
    25%
    22
    28.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    6.3%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    2
    2.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    18.8%
    3
    21.4%
    0
    0%
    0
    0%
    2
    16.7%
    2
    15.4%
    3
    25%
    13
    17.1%
    White
    7
    43.8%
    10
    71.4%
    4
    80%
    1
    25%
    9
    75%
    9
    69.2%
    8
    66.7%
    48
    63.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    5
    31.3%
    1
    7.1%
    1
    20%
    2
    50%
    1
    8.3%
    2
    15.4%
    1
    8.3%
    13
    17.1%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died
    Description AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
    Time Frame Day 1 to Day 603

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All safety evaluations were carried out on the safety analysis set.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Arm 1 Cohort 6 Arm 2 Cohort 6 Arm 3
    Arm/Group Description Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator. Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all. Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
    Measure Participants 16 17 5 28 4 12 13 12
    SAEs
    0
    0%
    0
    0%
    1
    20%
    1
    25%
    0
    0%
    1
    7.7%
    0
    0%
    0
    0%
    Deaths
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AEs
    15
    93.8%
    12
    85.7%
    5
    100%
    23
    575%
    3
    25%
    10
    76.9%
    10
    83.3%
    12
    15.8%
    2. Secondary Outcome
    Title Number of Responders in Cohort 1, 2, 3 and 6 at Day 57
    Description A "responder" was defined as a participant who fulfilled at least one of the 3 criteria compared to baseline: 1. Increase in visual acuity by at least 15 letters using Early Treatment Diabetic Retinopathy Study method, no increase in daily prednisone dose compared to week 1 and without worsening of uveitis. 2. Decrease in vitreous haze by 2 steps or more or for participants with anterior uveitis, resolution of the anterior chamber inflammation (i.e., no cells or only a rare cell in the anterior chamber (score 0 or trace (0.5+)), use measurement before dilation), no increase in daily prednisone dose compared to week 1 and without any worsening of uveitis.3 For those participant on a. >20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 10 mg/day or less. b. ≤20 mg/day of prednisone during week 1: Reduction in daily prednisone dose to 0 mg/day. c. topical corticosteroids during week 1: Reduction in daily topical corticosteroid dose to 0 during the last 2 weeks.
    Time Frame Day 1 (Baseline), Day 57

    Outcome Measure Data

    Analysis Population Description
    The Per Protocol Analysis Set (PPAS) consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 6 Arm 1 Cohort 6 Arm 2 Cohort 6 Arm 3
    Arm/Group Description Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
    Measure Participants 15 14 5 12 13 11
    Intermediate uveitis
    0
    0%
    1
    7.1%
    0
    0%
    1
    25%
    1
    8.3%
    3
    23.1%
    Pars planitis
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Posterior uveitis
    3
    18.8%
    0
    0%
    0
    0%
    1
    25%
    2
    16.7%
    0
    0%
    Panuveitis
    5
    31.3%
    4
    28.6%
    0
    0%
    2
    50%
    5
    41.7%
    5
    38.5%
    Anterior uveitis
    3
    18.8%
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Birdshot
    0
    0%
    0
    0%
    2
    40%
    0
    0%
    0
    0%
    0
    0%
    Sympathetic ophthalmia
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    Multi-focal choroiditis
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Number of Complete Responders in Cohort 2, 3 and 6 at Day 57
    Description A "complete responder" was defined as a participant who was able to stop all topical and systemic corticosteroids in both eyes and maintain remission of uveitis (=remains a responder as defined above) lasting at least 1 week (since stopping corticosteroids, if corticosteroids were given).
    Time Frame Day 1 (Baseline), Day 57

    Outcome Measure Data

    Analysis Population Description
    PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Cohort 2 Cohort 3 Cohort 6 Arm 1 Cohort 6 Arm 2 Cohort 6 Arm 3
    Arm/Group Description Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
    Measure Participants 14 5 12 13 11
    Intermediate uveitis
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    1
    8.3%
    Panuveitis
    1
    6.3%
    0
    0%
    1
    20%
    2
    50%
    2
    16.7%
    Pars planitis
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Anterior uveitis
    1
    6.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Birdshot
    0
    0%
    2
    14.3%
    0
    0%
    0
    0%
    0
    0%
    Sympathetic ophthalmia
    0
    0%
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    Multi-focal choroiditis
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Posterior uveitis
    0
    0%
    0
    0%
    1
    20%
    2
    50%
    0
    0%
    4. Secondary Outcome
    Title Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs
    Description Participants intake of oral prednisone or topical corticosteroid and other immunosuppressant drugs was reduced if participant was on up to 1.5 mg/kg/day dose of prednisone during the week prior to Day 1 or whom the resumption of prednisone was not considered the appropriate systemic therapy by investigator or who have never been on systemic immunosuppressive therapy and whose uveitis was so severe that, in the clinician's judgment, prednisone at a dose of 1.0-1.5 mg/kg/day alone will be insufficient to control the uveitis or participant with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
    Time Frame Baseline (Day 1) up to Month 8

    Outcome Measure Data

    Analysis Population Description
    PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Complete Study
    Arm/Group Description All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
    Measure Participants 0
    5. Secondary Outcome
    Title Number of Participants Who Were Able to Induce a Remission in Uveitis
    Description Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes by Day 57 visit after the first course of one or two doses of AIN457 were to be categorized as nonresponders and were to be discontinued from the study at the Day 85 visit. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
    Time Frame Day 1 to Day 85

    Outcome Measure Data

    Analysis Population Description
    PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Complete Study
    Arm/Group Description All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
    Measure Participants 0
    6. Secondary Outcome
    Title Number of Participants With Remission in Uveitis
    Description Participants with uveitis who were able to stop all topical and systemic topical corticosteroids in both eyes after the first course of one or two doses by Day 57 visit . The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
    Time Frame Baseline (Day 1) up to Month 8

    Outcome Measure Data

    Analysis Population Description
    PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Complete Study
    Arm/Group Description All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
    Measure Participants 0
    7. Secondary Outcome
    Title Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs
    Description A flare was defined as an increase of inflammation in either eye so that the anterior chamber cell score or the vitreous haze score become 1+ or greater. Vitreous haze was evaluated with an indirect ophthalmoscope and a hand-held 20-diopter lens. Haze is defined as a reduction in the clarity of fundus details seen through the vitreous, the degree of haze was quantified using standard National Eye Institute (NEI) photographs. The standard photographs provide a grading scale with photographs of fundi with vitreous haze grades "0" (zero), "trace" (which counts as 0.5+), 1+, 2+, 3+, and 4+. If the amount of vitreous haze appears to fall between two integer grades, the value would be recorded as halfway between the grades. The analysis was not conducted due to small sample size, insufficient number of participants and low initial doses; limited conclusions were drawn about dose response relationship leading to non summarization of results.
    Time Frame Day 1 to Day 57

    Outcome Measure Data

    Analysis Population Description
    PPAS consisted of all participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have at least one post-baseline assessment for one of the outcomes that define participants who respond.
    Arm/Group Title Complete Study
    Arm/Group Description All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
    Measure Participants 0

    Adverse Events

    Time Frame Day 1 to Day 603 (End of study)
    Adverse Event Reporting Description AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 5 Cohort 6 - Arm 1 Cohort 6 - Arm 2 Cohort 6 - Arm 3 Cohort 4 (Extension)
    Arm/Group Description Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22. Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all. Participants were administered with AIN457 300 mg s.c.and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43). Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups. Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
    All Cause Mortality
    Cohort 1 Cohort 2 Cohort 3 Cohort 5 Cohort 6 - Arm 1 Cohort 6 - Arm 2 Cohort 6 - Arm 3 Cohort 4 (Extension)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Serious Adverse Events
    Cohort 1 Cohort 2 Cohort 3 Cohort 5 Cohort 6 - Arm 1 Cohort 6 - Arm 2 Cohort 6 - Arm 3 Cohort 4 (Extension)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Infections and infestations
    Pyelonephritis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Urinary tract infection 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Injury, poisoning and procedural complications
    Tibia fracture 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Metabolism and nutrition disorders
    Hypokalaemia 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine cancer 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Cohort 1 Cohort 2 Cohort 3 Cohort 5 Cohort 6 - Arm 1 Cohort 6 - Arm 2 Cohort 6 - Arm 3 Cohort 4 (Extension)
    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 15/16 (93.8%) 12/17 (70.6%) 5/5 (100%) 3/4 (75%) 9/12 (75%) 10/13 (76.9%) 12/12 (100%) 20/28 (71.4%)
    Cardiac disorders
    Palpitations 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Ear and labyrinth disorders
    Ear pain 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Endocrine disorders
    Hypothyroidism 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Eye disorders
    Abnormal sensation in eye 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Anterior chamber flare 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Cataract 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Chalazion 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Colour blindness acquired 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Conjunctival hyperaemia 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Conjunctivitis allergic 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 3/28 (10.7%)
    Corneal disorder 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Dry eye 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 2/13 (15.4%) 0/12 (0%) 2/28 (7.1%)
    Eye irritation 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Eye pain 3/16 (18.8%) 2/17 (11.8%) 1/5 (20%) 0/4 (0%) 1/12 (8.3%) 1/13 (7.7%) 1/12 (8.3%) 3/28 (10.7%)
    Eye pruritus 1/16 (6.3%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Eye swelling 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Eyelid oedema 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 2/28 (7.1%)
    Foreign body sensation in eyes 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Iridocyclitis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 2/12 (16.7%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Iris adhesions 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Iris bombe 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Keratoconjunctivitis sicca 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Lacrimation increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Macular fibrosis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 1/28 (3.6%)
    Macular oedema 1/16 (6.3%) 2/17 (11.8%) 0/5 (0%) 1/4 (25%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Ocular hyperaemia 2/16 (12.5%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 3/28 (10.7%)
    Papilloedema 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Photophobia 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 2/28 (7.1%)
    Photopsia 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Pupillary reflex impaired 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Retinal detachment 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Retinal tear 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Scleritis 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Uveitis 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 2/12 (16.7%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Vision blurred 3/16 (18.8%) 1/17 (5.9%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 3/12 (25%) 1/28 (3.6%)
    Visual acuity reduced 2/16 (12.5%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Vitreous detachment 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Vitreous floaters 1/16 (6.3%) 1/17 (5.9%) 2/5 (40%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 4/28 (14.3%)
    Vitreous haemorrhage 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Gastrointestinal disorders
    Abdominal distension 1/16 (6.3%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Abdominal pain 0/16 (0%) 0/17 (0%) 0/5 (0%) 1/4 (25%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Abdominal pain lower 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Abdominal pain upper 3/16 (18.8%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Constipation 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Diarrhoea 0/16 (0%) 2/17 (11.8%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Inguinal hernia 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Mouth ulceration 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Nausea 1/16 (6.3%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Tooth disorder 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Vomiting 2/16 (12.5%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    General disorders
    Fatigue 2/16 (12.5%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 2/13 (15.4%) 2/12 (16.7%) 1/28 (3.6%)
    Infusion site extravasation 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Irritability 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 1/28 (3.6%)
    Oedema peripheral 0/16 (0%) 0/17 (0%) 2/5 (40%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Pain 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 1/28 (3.6%)
    Pyrexia 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Hepatobiliary disorders
    Non-alcoholic steatohepatitis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Immune system disorders
    Seasonal allergy 2/16 (12.5%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Infections and infestations
    Cellulitis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Ear infection 0/16 (0%) 0/17 (0%) 1/5 (20%) 1/4 (25%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Gastroenteritis 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Herpes zoster 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Hordeolum 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Lice infestation 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Nasopharyngitis 1/16 (6.3%) 1/17 (5.9%) 1/5 (20%) 0/4 (0%) 1/12 (8.3%) 1/13 (7.7%) 3/12 (25%) 6/28 (21.4%)
    Oral herpes 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Pharyngitis streptococcal 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Respiratory tract infection 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Sinusitis 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Upper respiratory tract infection 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Urinary tract infection 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 2/12 (16.7%) 1/28 (3.6%)
    Vaginitis bacterial 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Viral upper respiratory tract infection 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Vulvovaginal mycotic infection 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 1/12 (8.3%) 0/28 (0%)
    Injury, poisoning and procedural complications
    Back injury 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Joint injury 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Laceration 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Muscle strain 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Post procedural complication 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Radius fracture 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Investigations
    Alanine aminotransferase increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Aspartate aminotransferase increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Blood bilirubin increased 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Blood creatine phosphokinase increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Blood lactate dehydrogenase increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Blood pressure increased 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Blood triglycerides increased 2/16 (12.5%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Blood urine present 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Intraocular pressure increased 5/16 (31.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 2/28 (7.1%)
    Lipase increased 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Lymphocyte count decreased 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Lymphocyte percentage decreased 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Neutrophil percentage increased 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Protein urine 1/16 (6.3%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Weight decreased 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Metabolism and nutrition disorders
    Gout 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Increased appetite 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/16 (12.5%) 1/17 (5.9%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Back pain 2/16 (12.5%) 1/17 (5.9%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Exostosis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Flank pain 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Joint swelling 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Limb discomfort 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Muscle spasms 2/16 (12.5%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Musculoskeletal pain 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Musculoskeletal stiffness 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Myalgia 1/16 (6.3%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Pain in extremity 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Spondylitis 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Nervous system disorders
    Aphonia 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Dizziness 3/16 (18.8%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Headache 10/16 (62.5%) 4/17 (23.5%) 3/5 (60%) 2/4 (50%) 5/12 (41.7%) 3/13 (23.1%) 4/12 (33.3%) 1/28 (3.6%)
    Hyperaesthesia 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 1/28 (3.6%)
    Migraine 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Paraesthesia 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 2/28 (7.1%)
    Presyncope 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Sinus headache 2/16 (12.5%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Somnolence 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Syncope 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Tension headache 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 1/12 (8.3%) 1/28 (3.6%)
    Psychiatric disorders
    Anxiety 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 2/13 (15.4%) 0/12 (0%) 0/28 (0%)
    Anxiety disorder 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Depression 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Insomnia 0/16 (0%) 0/17 (0%) 0/5 (0%) 1/4 (25%) 0/12 (0%) 0/13 (0%) 1/12 (8.3%) 0/28 (0%)
    Nervousness 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Renal and urinary disorders
    Nephrolithiasis 1/16 (6.3%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Reproductive system and breast disorders
    Uterine haemorrhage 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Uterine spasm 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/16 (0%) 2/17 (11.8%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Nasal congestion 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Oropharyngeal pain 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 1/28 (3.6%)
    Rhinorrhoea 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Sinus congestion 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Vocal cord disorder 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 1/12 (8.3%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Alopecia 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 1/28 (3.6%)
    Dermatitis acneiform 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Dermatitis contact 0/16 (0%) 0/17 (0%) 0/5 (0%) 1/4 (25%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Eczema 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 0/12 (0%) 0/28 (0%)
    Madarosis 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Pruritus 0/16 (0%) 1/17 (5.9%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 1/12 (8.3%) 2/28 (7.1%)
    Pruritus generalised 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 2/12 (16.7%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Psoriasis 0/16 (0%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 2/28 (7.1%)
    Rash 1/16 (6.3%) 2/17 (11.8%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 1/13 (7.7%) 1/12 (8.3%) 1/28 (3.6%)
    Rash pruritic 0/16 (0%) 0/17 (0%) 1/5 (20%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Skin odour abnormal 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)
    Vascular disorders
    Hot flush 1/16 (6.3%) 0/17 (0%) 0/5 (0%) 0/4 (0%) 0/12 (0%) 0/13 (0%) 0/12 (0%) 0/28 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (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:
    NCT00685399
    Other Study ID Numbers:
    • CAIN457A2208
    • 2011-001243-67
    First Posted:
    May 28, 2008
    Last Update Posted:
    Jul 17, 2017
    Last Verified:
    Jun 1, 2017