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Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome (REMITTER)

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ClinicalTrials.gov Identifier: NCT00465985
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : February 11, 2011
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muckle Wells Syndrome
Interventions Drug: ACZ885
Drug: Placebo
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks. Placebo subcutaneous injection every 8 weeks.
Period Title: Part I - Open-label Treatment Period
Started 35 [1] 0
Completed 31 [2] 0
Not Completed 4 0
Reason Not Completed
Unsatisfactory therapeutic effect             4             0
[1]
All patients received treatment with ACZ885 in Part I of the study.
[2]
Only patients with a complete response completed Part I and entered Part II of the study.
Period Title: Part II - 1:1 ACZ885:Placebo
Started 15 [1] 16
Completed 15 4
Not Completed 0 12
Reason Not Completed
Unsatisfactory therapeutic effect             0             12
[1]
Patients with complete response to treatment entered Part II and were randomized to ACZ885 ,placebo.
Period Title: Part III - Open-label Treatment Period
Started 31 [1] 0
Completed 29 0
Not Completed 2 0
Reason Not Completed
Unsatisfactory therapeutic effect             1             0
Adverse Event             1             0
[1]
All patients received treatment with ACZ885 in Part III of the study.
Arm/Group Title ACZ885
Hide Arm/Group Description ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
34  (14.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
25
  71.4%
Male
10
  28.6%
1.Primary Outcome
Title Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)
Hide Description Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.
Time Frame 32 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo subcutaneous injection every 8 weeks.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: percent of participants
0 81.3
2.Primary Outcome
Title Number of Participants Who Experienced a Disease Flare in Part II
Hide Description Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) > 30 mg/L and either a PGA > minimal, or PGA equal to minimal and > minimal SD.
Time Frame 32 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo subcutaneous injection every 8 weeks.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: Participants
0 13
3.Secondary Outcome
Title Number of Participants With Treatment Response in Part I (After 8 Weeks)
Hide Description Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by >30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA > 30 mg/L and either PGA > minimal or PGA = minimal and SD > minimal. Non-responders = no PR by Day 8 or no CR by Day 15.
Time Frame 8 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
Complete response 31
Partial response 2
Disease flare 1
Non-responder (protocol violation) 1
4.Secondary Outcome
Title Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)
Hide Description

A 5-point scale was used for the Physician’s global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items:

  • skin disease (urticarial skin rash)
  • arthralgia
  • myalgia
  • headache/migraine
  • conjunctivitis
  • fatigue/malaise
  • other symptoms related to autoinflammatory syndrome
  • other symptoms not related to autoinflammatory syndrome
Time Frame 32 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo subcutaneous injection every 8 weeks.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: Participants
Absent 8 0
Minimal 7 4
Mild 0 8
Moderate 0 4
Severe 0 0
5.Secondary Outcome
Title Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.
Hide Description [Not Specified]
Time Frame Week 8 and Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)population and LOCF.
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo subcutaneous injection every 8 weeks.
Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: mg/L
C reactive protein (CRP (mg/L)) 1.10  (3.086) 19.93  (24.175)
Serum amyloid A (SAA (mg/L)) 2.27  (8.604) 71.09  (136.637)
6.Secondary Outcome
Title Pharmacokinetics (CLD (L/d))
Hide Description Assessed serum clearance of ACZ885.
Time Frame 48 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients in Part I and Part II who received at least one dose of ACZ885.
Arm/Group Title ACZ885
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: L/day
0.177  (0.085)
7.Secondary Outcome
Title Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.
Hide Description [Not Specified]
Time Frame until Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population.
Arm/Group Title ACZ885
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: pg/mL
19.047  (17.6609)
8.Secondary Outcome
Title Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.
Hide Description [Not Specified]
Time Frame 32 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population.
Arm/Group Title ACZ885 Placebo
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo subcutaneous injection every 8 weeks.
Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: pg/mL
21.943  (10.3698) 0.596  (0.7289)
9.Secondary Outcome
Title Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.
Hide Description [Not Specified]
Time Frame 48 weeks after study start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population.
Arm/Group Title ACZ885
Hide Arm/Group Description:
ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: pg/mL
23.018  (16.5193)
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part I ACZ885 Part II ACZ885 Part II Placebo Part III ACZ885 Entire Study ACZ885
Hide Arm/Group Description ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks. ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks. Placebo subcutaneous injection every 8 weeks. ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks. Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
All-Cause Mortality
Part I ACZ885 Part II ACZ885 Part II Placebo Part III ACZ885 Entire Study ACZ885
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part I ACZ885 Part II ACZ885 Part II Placebo Part III ACZ885 Entire Study ACZ885
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/15 (0.00%)   0/16 (0.00%)   2/31 (6.45%)   2/35 (5.71%) 
Ear and labyrinth disorders           
Vertigo  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
Eye disorders           
Blindness unilateral  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
General disorders           
Pyrexia  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
Infections and infestations           
Sepsis  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
Injury, poisoning and procedural complications           
Post lumbar puncture syndrome  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
Investigations           
Intraocular pressure increased  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part I ACZ885 Part II ACZ885 Part II Placebo Part III ACZ885 Entire Study ACZ885
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/35 (77.14%)   15/15 (100.00%)   14/16 (87.50%)   24/31 (77.42%)   35/35 (100.00%) 
Blood and lymphatic system disorders           
Lymphocytosis  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Neutropenia  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Ear and labyrinth disorders           
Hypoacusis  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Tinnitus  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Vertigo  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  3/35 (8.57%) 
Eye disorders           
Erythema of eyelid  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Eye pain  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Gastrointestinal disorders           
Abdominal discomfort  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Abdominal pain  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Abdominal pain upper  1  2/35 (5.71%)  0/15 (0.00%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Aphthous stomatitis  1  0/35 (0.00%)  1/15 (6.67%)  1/16 (6.25%)  1/31 (3.23%)  3/35 (8.57%) 
Diarrhoea  1  0/35 (0.00%)  1/15 (6.67%)  2/16 (12.50%)  5/31 (16.13%)  7/35 (20.00%) 
Haemorrhoids  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Mouth ulceration  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Nausea  1  3/35 (8.57%)  1/15 (6.67%)  1/16 (6.25%)  1/31 (3.23%)  5/35 (14.29%) 
Rectal haemorrhage  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Stomach discomfort  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Tooth impacted  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Vomiting  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  1/31 (3.23%)  1/35 (2.86%) 
General disorders           
Asthenia  1  2/35 (5.71%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Chest pain  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Fatigue  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Hangover  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Influenza like illness  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Non-cardiac chest pain  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Oedema peripheral  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Immune system disorders           
Allergy to arthropod bite  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
House dust allergy  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Seasonal allergy  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Infections and infestations           
Bronchitis  1  3/35 (8.57%)  1/15 (6.67%)  1/16 (6.25%)  0/31 (0.00%)  4/35 (11.43%) 
Gastroenteritis  1  0/35 (0.00%)  2/15 (13.33%)  1/16 (6.25%)  2/31 (6.45%)  4/35 (11.43%) 
Herpes zoster  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Influenza  1  1/35 (2.86%)  2/15 (13.33%)  3/16 (18.75%)  0/31 (0.00%)  6/35 (17.14%) 
Nasopharyngitis  1  4/35 (11.43%)  4/15 (26.67%)  2/16 (12.50%)  4/31 (12.90%)  12/35 (34.29%) 
Oral herpes  1  1/35 (2.86%)  0/15 (0.00%)  2/16 (12.50%)  0/31 (0.00%)  3/35 (8.57%) 
Pharyngitis  1  0/35 (0.00%)  1/15 (6.67%)  1/16 (6.25%)  2/31 (6.45%)  4/35 (11.43%) 
Rhinitis  1  4/35 (11.43%)  1/15 (6.67%)  2/16 (12.50%)  0/31 (0.00%)  6/35 (17.14%) 
Tinea pedis  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Tooth abscess  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Tooth infection  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Upper respiratory tract infection  1  0/35 (0.00%)  1/15 (6.67%)  1/16 (6.25%)  1/31 (3.23%)  3/35 (8.57%) 
Urinary tract infection  1  0/35 (0.00%)  2/15 (13.33%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Viral infection  1  0/35 (0.00%)  2/15 (13.33%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Injury, poisoning and procedural complications           
Contusion  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Face injury  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Joint sprain  1  0/35 (0.00%)  2/15 (13.33%)  1/16 (6.25%)  0/31 (0.00%)  3/35 (8.57%) 
Traumatic haematoma  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Investigations           
Liver function test abnormal  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Weight increased  1  3/35 (8.57%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  4/35 (11.43%) 
Metabolism and nutrition disorders           
Hypercholesterolaemia  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Hypertriglyceridaemia  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Back pain  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  3/35 (8.57%) 
Groin pain  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Joint swelling  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Muscle contracture  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  1/31 (3.23%)  2/35 (5.71%) 
Muscle spasms  1  2/35 (5.71%)  0/15 (0.00%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Musculoskeletal chest pain  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  1/31 (3.23%)  1/35 (2.86%) 
Musculoskeletal pain  1  0/35 (0.00%)  1/15 (6.67%)  1/16 (6.25%)  2/31 (6.45%)  4/35 (11.43%) 
Pain in extremity  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  3/35 (8.57%) 
Tendonitis  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Nervous system disorders           
Complex regional pain syndrome  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Headache  1  0/35 (0.00%)  2/15 (13.33%)  0/16 (0.00%)  3/31 (9.68%)  5/35 (14.29%) 
Hypoaesthesia  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Memory impairment  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Nystagmus  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Paraesthesia  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Sciatica  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Tension headache  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Psychiatric disorders           
Anxiety  1  0/35 (0.00%)  1/15 (6.67%)  1/16 (6.25%)  0/31 (0.00%)  2/35 (5.71%) 
Depression  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Stress  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders           
Allergic cough  1  0/35 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  1/35 (2.86%) 
Cough  1  0/35 (0.00%)  2/15 (13.33%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Epistaxis  1  1/35 (2.86%)  0/15 (0.00%)  1/16 (6.25%)  1/31 (3.23%)  3/35 (8.57%) 
Oropharyngeal pain  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  1/31 (3.23%)  3/35 (8.57%) 
Respiratory tract congestion  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  1/31 (3.23%)  2/35 (5.71%) 
Rhinitis allergic  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Rhinorrhoea  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders           
Acne  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Erythema  1  1/35 (2.86%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  3/35 (8.57%) 
Hyperhidrosis  1  0/35 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  2/31 (6.45%)  2/35 (5.71%) 
Pruritus  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  1/31 (3.23%)  3/35 (8.57%) 
Vascular disorders           
Haematoma  1  1/35 (2.86%)  0/15 (0.00%)  1/16 (6.25%)  0/31 (0.00%)  2/35 (5.71%) 
Hot flush  1  1/35 (2.86%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  2/35 (5.71%) 
Hypertension  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Orthostatic hypotension  1  0/35 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/31 (0.00%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
The outcomes for this study were reported in separate tables for each period. The SAE and AEs were reported in all in one table.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00465985     History of Changes
Other Study ID Numbers: CACZ885D2304
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: November 16, 2010
Results First Posted: February 11, 2011
Last Update Posted: August 28, 2017